RU2852964C1 - Nicotine replacement therapy based on biomarkers - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine and can be used for nicotine replacement therapy. A device is proposed that is capable of: determining a smoking cessation programme for the user; determining the sensor signal from the dispenser for dispensing the nicotine composition; determining the intensity of consumption of the nicotine composition associated with the user based on the sensor signal from the dispenser for dispensing the nicotine composition; determine the carbon monoxide saturation level for the user; determine the event of detecting smoking if the carbon monoxide saturation level exceeds a threshold value; determine the intensity of cigarette consumption by the user using the event of detecting smoking; determining a programme intervention event based on the phase of the smoking cessation programme, the intensity of nicotine compound consumption, and the intensity of cigarette consumption, wherein the phase is one of a phase of reducing the number of cigarettes smoked, a stabilisation phase, or a phase of reducing the amount of nicotine consumed; determining the duration of the smoking cessation programme's phase based on the programme intervention event and the intensity of cigarette consumption; and determining a modification to the smoking cessation programme based on the programme intervention event and the specified duration, wherein the modification increases the likelihood of smoking cessation.

EFFECT: biomarker-based nicotine replacement therapy.

19 cl, 63 dwg

Description

Cross-references to related applications

[001] This application claims the benefit of U.S. Provisional Patent Application No. 63/018,035, filed April 30, 2020, the contents of which are incorporated herein by reference in their entirety.

Prerequisites for the creation of the invention

[002] Smokers, other tobacco users, and e-cigarette users often use tobacco or nicotine products because of nicotine addiction. Specifically, such users will frequently use these products even though they may experience negative health consequences associated with biological and/or physiological dependence on nicotine. Some of these users desire to quit smoking. However, the nicotine addiction of these users may result in their attempts to quit being unsuccessful.

The essence of the invention

[003] A device for providing nicotine replacement therapy may be proposed. This device may comprise a dispenser for dispensing a nicotine composition. This device may comprise an actuator mounted to actuate the dispenser. This device may comprise a locking mechanism that may be movable between an operating position that allows the actuator to move so as to actuate the dispenser, and an inoperative position in which movement of the actuator may be impossible. The device may comprise a processor. The processor may be configured to determine the amount of nicotine that was previously consumed by the user. The processor may be configured to send a signal to the locking mechanism for the locking mechanism, which causes the locking mechanism to move to the inoperative position.

[004] A device for providing nicotine replacement therapy may be provided. The device may comprise a memory device and a processor. The processor may be configured to perform a method. It may be determined that a user experiences an urge to consume nicotine. The amount of nicotine previously consumed by the user may be determined. A nicotine threshold for the user may be determined. It may be determined that the amount of nicotine previously consumed by the user is below the nicotine threshold. A message may be sent to the user recommending that a portion of nicotine be dispensed to reduce the urge to consume nicotine.

[005] A device for providing nicotine replacement therapy may be proposed. This device may comprise a dispenser housing. This device may comprise a dispenser for dispensing a portion of a nicotine composition. This device may comprise a drive element mounted to actuate the dispenser. This device may comprise a carriage mounted to move relative to the dispenser housing upon contact with the drive element. This device may comprise a sensor configured to sense the movement of the carriage. The device may comprise a processor. The processor may be configured to perform one or more actions. Based on a signal from the sensor, it may be determined that a portion of the nicotine composition has been dispensed. An indication of the portion of the nicotine composition may be sent.

[006] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. The processor may be configured to perform one or more actions. A smoking cessation program may be defined for a user. An intervention event of the program may be determined based on a phase of the smoking cessation program. A marker associated with the user may be determined. A change in the smoking cessation program may be determined based on an intervention event of the program.

[007] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor that may be configured to perform one or more actions. A phase of a smoking cessation program associated with a user may be determined. A smoking detection event may be determined based on a biomarker associated with the user. A modification to the smoking cessation program may be determined based on the phase and the smoking detection event.

[008] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. The processor may be configured to determine a phase of a smoking cessation program associated with a user. An event of detecting the fact of nicotine consumption may be determined. A modification to the smoking cessation program may be determined based on the phase and the event of detecting the fact of nicotine consumption.

[009] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. A biomarker associated with the user may be determined. Using the biomarker associated with the user, an urge to consume nicotine may be determined. The user may be offered an intervention based on the urge to consume nicotine.

[010] A smart nicotine replacement therapy (NRT) device may include one or more integrated mechanical and/or biological sensors. For example, such a device may include one or more mechanisms for nicotine consumption detection, restlessness detection, position detection, replacement vial placement, vial authentication, and/or dose tracking. One or more applications running on the device or other device(s) may provide a dynamic, personalized smoking cessation plan based on nicotine consumption, sensor data, biological, and behavioral response data to facilitate cessation of cigarette smoking, e-cigarette smoking, tobacco smoking, and nicotine use. The smart NRT device may be used in combination with a smartphone and/or smartwatch to provide tools for monitoring and correcting the smoking cessation process.

[011] A smart NRT device may include a sensor for measuring a physiological parameter. For example, a smart NRT device may include a carbon monoxide (CO) sensor for measuring the CO level in the user's body. The CO measurement may be performed, for example, by the smart NRT device or another device during a smoking cessation program. Information about the user's CO level in the body may be used to provide the user with real-time feedback indicating that quitting smoking provides a significant biological benefit.

[012] The NRT device can be used in conjunction with a smartwatch to obtain information such as biomarker information. The biomarker can be heart rate (HR), heart rate variability (HRV), blood pressure, temperature, respiratory rate, oxygen saturation, carboxyhemoglobin level, carbon monoxide level, galvanic skin response (GSR), position, user gestures, motor and/or other activity, and/or the like. A potential urge to smoke can be determined based on information obtained from the NRT device, smartwatch, and/or smartphone. A preferred message for NRT use can be generated before the urge to smoke occurs.

[013] A user's smoking behavior or nicotine dependence may be determined based on real-time feedback on biological indicators, biomarkers, and/or behavioral support elements. The feedback information may be used to tailor a smoking cessation plan for the user during a quit attempt.

[014] The urge to smoke may represent a need for additional amounts of a substance or an activity consisting of the desire to experience euphoria or other states. The urge to smoke may include a desire to avoid the withdrawal symptoms associated with quitting smoking. The urge to smoke may represent a desire to consume a specific substance, such as nicotine.

[015] A device for providing nicotine replacement therapy (e.g., a smart NRT device) may include a dispenser for dispensing a nicotine composition and an actuator mounted to actuate the dispenser. This device may include a locking mechanism that may be movable between an operating position in which movement of the actuator is possible to actuate the dispenser, and a non-operating position in which movement of the actuator may be impossible. This device may include one or more processors as described herein. This device may include a sensor for measuring a physiological parameter. For example, this device may include a CO sensor. The level of CO in the user's body can be determined, and the CO level reading can be sent (e.g., to a processor or another device via a transmitter). This device may include one or more sensors for determining one or more physiological parameters of the user. The sensors may include one or more of a photoplethysmogram (PPG) sensor, a carbon monoxide sensor, a volatile organic compound (VOC) sensor, a spirometer sensor, an electrocardiograph (EKG) sensor, a galvanic skin reflex sensor, a temperature sensor, a pressure sensor, and/or the like.

[016] The device may include a processor configured to determine whether to send a signal to the locking mechanism to cause the locking mechanism to move to an inoperative position or to an operative position depending on the age of the user, the geographic location of the user, and/or the amount of nicotine that the user has previously consumed. For example, a signal to the locking mechanism that causes the locking mechanism to move to an inoperative position may be sent if it is determined that the amount of nicotine that the user has previously consumed exceeds a nicotine threshold. Such a nicotine threshold may be customized based on various data collected by the NRT device and/or other device(s) connected to the NRT device.

[017] This device may include a dispensing detection and tracking mechanism for detecting and tracking the number of doses dispensed. This device may include a mechanism for measuring the dispensed portion of the nicotine composition associated with the pump or atomizer. The dispensing tracking mechanism may include a contactless sensor. For example, this device may include a carriage (e.g., a magnetic carriage) mounted so as to move relative to the dispenser in contact with a drive element and a sensor (e.g., a magnetic sensor) configured to sense the movement of the carriage. The magnetic sensor may detect when the magnetic carriage is within range. The dispensed portion of the nicotine composition can be determined based on a signal from the sensor. An indication of the portion may be sent (e.g., to a processor in this device or to another device via a transmitter). This device may include a transmitter for sending a signal indicating the amount of nicotine composition consumed by the user.

[018] This device may include a receiver for receiving a signal that instructs the locking mechanism to move to an inoperative position (e.g., a lock activation message) and/or a signal that instructs the locking mechanism to move to an operative position (e.g., a resume use message). The signals may be received from a smartphone, smartwatch, and/or other device.

[019] It may be determined whether a user is experiencing an urge to consume nicotine, and a message may be sent or displayed to dispense a nicotine formulation to the user to reduce the urge to consume nicotine. A message may be sent instructing the nicotine dispensing device to allow the dispensing of a nicotine dose. A potential urge to consume nicotine may be determined based on at least one of motion detection, physical position, time of day, scheduled activity, the user's calendar, social media data, biometric measurement (e.g., resting heart rate, real-time heart rate data, skin temperature, etc.), user-initiated triggers, and/or triggers initiated based on various data.

Brief description of graphic materials

[020] FIGS. 1A-B show an example of a smart device for nicotine replacement therapy (NRT) in front and side views, respectively.

[021] FIG. 1B is a functional block diagram of some electrical components of an example NRT smart device.

[022] FIG. 2A is an architectural diagram of an example system for supporting a smart NRT device. FIG. 2B is a block diagram of the message exchange in the example system.

[023] FIGS. 3A-B are schematic illustrations of an example of a smart NRT device.

[024] FIG. 3B shows an example of a pumping mechanism that may be used by a smart NRT device.

[025] FIGS. 4A-D are perspective views of the NRT smart device in which the dispenser head is in a non-operating position (e.g., in a locked position).

[026] FIGS. 5A-D are perspective views of the NRT smart device showing the dispenser head in an operating position (e.g., in an unlocked position).

[027] FIGS. 6A-B are schematic views of an example of one or more components in a smart NRT device that may be used to dispense a nicotine formulation.

[028] FIG. 7 is a schematic view of components in a smart NRT device that may be used to dispense a nicotine composition and/or record the fact that a nicotine composition has been dispensed.

[029] FIGS. 8A-B are schematic views of a carriage system in a smart NRT device that may be used to detect and/or record the insertion of a vial, the removal of a vial, and/or the dispensing of nicotine.

[030] FIG. 9 is a schematic view of a smart NRT device that may include a sensor, such as a carbon monoxide sensor, for detecting tobacco consumption by a user.

[031] FIGS. 10A-B are schematic views of a locking mechanism in a smart NRT device that can be used to prevent the dispensing of a nicotine composition.

[032] FIG. 11A shows an example of a user interface for entering data on cigarette or other tobacco product consumption.

[033] FIG. 11B shows an example of a user interface for collecting information related to nicotine consumption.

[034] FIG. 12 illustrates an example of user interface(s) for displaying progress in a nicotine replacement therapy program.

[035] FIG. 13 illustrates an example of user interface(s) for specifying personalized weekly and/or daily goals and recommended actions.

[036] FIG. 14 illustrates an example of user interface(s) for creating a personalized cigarette substitution plan.

[037] FIG. 15A shows an example of a user interface that suggests an action before the urge to consume nicotine occurs.

[038] FIG. 15B shows an example of a user interface for entering an action aimed at overcoming a predicted urge to smoke.

[039] FIG. 15B shows an example of a user interface that prompts a user to confirm the consumption of cigarettes or another tobacco product.

[040] FIG. 16A illustrates an example of a nicotine/smoking cessation program overview.

[041] FIG. 16B shows an example of a user interface for providing feedback on carbon monoxide level information that is collected and monitored throughout the program.

[042] FIG. 16B shows an example of a user interface for providing feedback on heart rate information that is collected and monitored throughout the program.

[043] FIGS. 17A-B illustrate examples of user interfaces that offer actions aimed at obtaining benefits from implementing the nicotine cessation procedure.

[044] FIG. 18 shows an example of a flow chart for providing a personalized nicotine/smoking cessation procedure.

[045] FIG. 19 shows an example of a block diagram of the control of the locking mechanism.

[046] FIG. 20 shows an example of an NRT system.

[047] FIG. 21 shows an example of a 12-week NRT procedure that can be adjusted based on sensor feedback.

[048] FIG. 22 shows an example of a flow chart for updating the NRT program.

[049] FIG. 23A is an example of a flow chart for identifying a specific model and updating a user-customized NRT program based on the identified model.

[050] FIG. 23B shows an example of a flow chart for identifying a specific model and updating NRT programs for multiple users based on the identified model.

[051] FIG. 24 shows examples of biometric indicators related to smoking.

[052] FIG. 25 is an example flow chart for modifying a user-personalized NRT program based on various biometric data sources and nicotine consumption data sources.

[053] FIG. 26 shows an example of a flow chart for identifying a smoking urge. When a nicotine/smoking urge is detected, the use of NRT may be recommended to alleviate the smoking urge.

[054] FIG. 27 shows an example of a behavior intervention flow chart.

[055] FIG. 28 illustrates an example of a multi-phase smoking cessation program.

[056] FIG. 29 is a flow chart of an example of a smoking cessation program that provides personalized nicotine replacement therapy.

[057] FIG. 30 shows an example of a flow chart for a modification in a smoking cessation program.

[058] FIG. 31A shows an example of a flow chart of a smoking urge detection event.

[059] FIG. 31B shows an example of a table for determining a smoking urge detection event.

[060] FIG. 32A shows an example of a program intervention event flow chart.

[061] FIGS. 32B-32C illustrate example tables for determining a program intervention event.

[062] FIG. 33A shows an example of a flow chart of a smoking detection event.

[063] FIG. 33B shows an example of a table for determining a smoking detection event.

[064] FIG. 34 illustrates a method for providing nicotine replacement therapy that can be implemented by the device.

[065] FIG. 35 shows an example of a method for providing nicotine replacement therapy that may utilize a biomarker.

[066] FIG. 36 illustrates an example of a method for providing nicotine replacement therapy that may utilize a biomarker to detect an urge to consume nicotine.

Detailed description

[067] Nicotine replacement therapy (NRT) is a method of reducing the severe withdrawal symptoms associated with cessation of cigarette smoking and/or nicotine use. This effect can be achieved with NRT by replacing nicotine from cigarettes, tobacco products, or e-cigarettes with nicotine from an alternative source, such as a patch, gum, nasal spray, inhaler, lozenge/tablet, oral spray, etc. NRT has been shown to increase the likelihood of successful completion of smoking and/or nicotine cessation.

[068] Figs. 1A and 1B illustrate an example of a NRT device 100 in front and side views, respectively. The device 100 may be or may include an atomizer device for oral delivery of nicotine. To obtain a dose of nicotine, the user grasps the device 100 by the housing 102 and presses the actuator 104 (in the direction indicated by arrow 106), while directing the nozzle 108 to distribute a mist of the nicotine composition, for example, under the user's tongue. The example of the NRT device 100 may include mechanical elements, such as a child-resistant actuator and an internal replaceable vial for holding the liquid nicotine composition.

[069] An example of an NRT device 100 may further include some digital computing elements, such as to improve smoking behavior modification and nicotine addiction. The NRT device 100 may include advanced elements such as digital processing means, data transmission means, sensors, electromechanical interaction means, user feedback means, and the like. For example, the NRT device 100 may include a carbon monoxide (CO) sensor (not shown) integrated into the device 102. To use it, the user may squeeze its seal around the perimeter of the mouthpiece 110 and exhale, releasing air from the lungs through the inlet 112 of the device past the internal CO sensor and from the outlet nozzle 114. The CO sensor may measure the relative concentration of CO in the air exhaled by the person. The relative concentration of CO in the air exhaled by the person may indicate the number of cigarettes, which characterizes the smoking behavior of this person. And this data is very useful for tracking and adapting the smoking and/or nicotine cessation procedure.

[070] The NRT device 100 with such digital computing elements may be included in a larger system to further improve smoking behavior modification and nicotine addiction. This system may include aspects such as smartphones, wearable devices (e.g., smart watches) with biometric and activity tracking features, cloud processing, predictive algorithms, adaptive algorithms, etc. For example, this system may be a closed-loop NRT smoking cessation system. It may also include the NRT device 100 with an integrated CO sensor, dose detection mechanisms, restlessness detection, position detection, replaceable vial authentication, dose concentration tracking, etc. A corresponding NRT application and/or behavioral support application (e.g., a smartphone application, a smartwatch application, a tablet application, and/or a PC application), which can be used in combination with a smartwatch equipped with sensors for collecting biological data (e.g., biomarkers) on activity, heart rate, heart rate variability, etc., can provide a dynamic, personalized smoking cessation plan for the user. This plan can be based on collected nicotine consumption data, sensor data, biological data, behavioral response data, etc. This plan can be supported by adaptive and/or predictive algorithms for using this data to adjust the planned smoking cessation procedure and/or predict events, such as, for example, urges to smoke, which makes the device 100 part of a comprehensive set of tools for monitoring nicotine consumption and, accordingly, adjusting the smoking cessation procedure for a specific user. Such a device 100 and/or system may assist a subject in appropriately using nicotine substitutes, promote adherence to and completion of a planned NRT procedure or NRT procedure route for smoking cessation, and ultimately lead to successful smoking cessation and/or cessation of nicotine consumption.

[071] FIG. 1C is a functional block diagram of some electrical components 120 of an example NRT device 100. These components 120 may be included in a portable nicotine dispensing device, such as device 100. Such a dispenser may include a dispenser housing and a nicotine substitute dispensing mechanism. For example, the dispenser may be configured to switch between an operating configuration and a non-operating configuration. For example, in the non-operating configuration, a locking mechanism in the device may be activated to prevent the dispensing of the nicotine formulation. Components 120 may include sensing, electromechanical actuation, data communication, and digital processing functionality to control the structure and operation of the dispenser. In examples, components 120 may include a controller 122, communication interfaces 124, sensors 126, electrical and electromechanical actuators 128, and a power management subsystem 130.

[072] For example, controller 122 may include processor 132, memory 134, and one or more input/output devices 136. Controller 122 may be any suitable microcontroller, microprocessor, field programmable gate array (FPGA), application-specific integrated circuit (ASIC), or the like that is suitable for receiving data, computing, storing, and transmitting output data and/or signals. Controller 122 may be a device suitable for operating an embedded application. For example, controller 122 may include a system-on-chip (SOC).

[073] The processor 132 may include one or more data processing units. The processor 132 may be a processor of any suitable depth for performing the digital processing requirements described herein. For example, the processor 132 may include a 4-bit processor, a 16-bit processor, a 32-bit processor, a 64-bit processor, or the like.

[074] Memory device 134 may include any component or set of components suitable for storing data. For example, memory device 134 may include volatile memory and/or non-volatile memory. Memory device 134 may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, or the like.

[075] The input/output devices 136 may include any devices suitable for receiving and/or sending information. This information may be in the form of coded data (e.g., other digital components) and/or analog data (e.g., from analog sensors). The input/output devices 136 may include devices such as serial input/output ports, parallel input/output ports, universal asynchronous receiver/transmitters (UARTs), input/output contacts of discrete logic components, analog-to-digital converters, digital-to-analog converters. The input/output devices 136 may include specific interfaces with computing peripherals and auxiliary circuits, such as timers, event counters, pulse width modulation (PWM) generators, control circuits, clock signal generators, and the like. Input/output devices 136 may provide data transfer within and between components 100, such as data transfer between controller 122 and sensors 126, between controller 122 and actuators 128, between controller 122 and communication interfaces 124, and between controller 122 and power management subsystem 130, and may also be used as a channel for any other combination of components 120. Components 120 may also support direct communication, such as between sensor 126 and power management system 130.

[076] Communication interfaces 124 may include a transmitter 138 and/or a receiver 140. Communication interfaces 124 may include one or more transmitters 138 and/or receivers 140. Transmitter 138 and receiver 140 may include any electrical components suitable for transmitting data to and/or from electrical components 120. For example, transmitter 138 and receiver 140 may provide wired data transmission and/or wireless data transmission to devices external to components 120 and/or external to device 100 in which components 120 are integrated.

[077] The transmitter 138 and the receiver 140 may provide wired data transmission using any suitable communication protocol, such as protocols suitable for embedded applications. For example, the transmitter 138 and the receiver 140 may be configured to provide data transmission via a universal serial bus (USB), data transmission over an Ethernet local area network (LAN), and the like.

[078] Transmitter 138 and receiver 140 may provide wireless communication using any suitable communication protocol, such as protocols suitable for embedded applications. For example, transmitter 138 and receiver 140 may be configured to provide a wireless personal area network (PAN) communication protocol, a wireless local area network (LAN) communication protocol, a wide area network (WAN) communication protocol, and the like. The transmitter 138 and the receiver 140 may be configured to transmit data via Bluetooth, such as any supported or custom version of Bluetooth and/or any supported or custom protocol, including, for example, the A/V Control Transport Protocol (AVCTP), A/V Distribution Transport (AVDTP), Bluetooth Network Encapsulation Protocol (BNEP), IrDA Interoperability (IrDA), Multi-Channel Adaptation Protocol (MCAP), and RF Communications Protocol (RFCOMM), etc. In examples, the transmitter 138 and the receiver 140 may be configured to transmit data via the Bluetooth Low Energy (LE) protocol and/or the Bluetooth Internet of Things for physical objects (IoT). The transmitter 138 and the receiver 140 may be configured to transmit data via mesh network protocols, such as, for example, ZigBee, Z-Wave, Thread, etc. Such protocols can allow transmitter 138 and receiver 140 to exchange data with neighboring devices, such as the user's cell phone and/or smartwatch. Communication with a local network device, such as a mobile phone, provides additional capabilities for transmitting data between other devices on the wide area network (WAN), to remote devices, devices connected to the internet, to the corporate network, and so on.

[079] The transmitter 138 and the receiver 140 may be configured to exchange data via LAN protocols, such as 802.11 wireless protocols, such as Wi-Fi technology, including, but not limited to, data transmission in the 2.4 GHz, 5 GHz, and 60 GHz frequency bands. Such protocols may allow the transmitter 138 and the receiver 140 to exchange data with a local network access point, such as a wireless router, such as one installed at the user's home or office. And exchange of data with a local network access point provides the ability to additionally exchange data with other devices present on the local network, or via a WAN network with remote devices, devices connected to the Internet, a corporate network, etc.

[080] The transmitter 138 and the receiver 140 may be configured to communicate via mobile wireless communication protocols such as the Global System for Mobile Communications (GSM), the 4G Long Term Evolution (LTE) standard, the 5G and 5G New Radio Network (NR), and any number of mobile Internet of Things (IoT) protocols. Such protocols facilitate communication between the transmitter 138 and the receiver 140, such as when the user is mobile, moving away from home or office, and without manual configuration.

[081] The sensors 126 may include any device suitable for detecting an aspect of its surrounding environment, such as biometric, physical, chemical, mechanical, electrical, encoded information, and the like. The controller 122 may interact with one or more sensors 126. The sensors 126 may be biometric sensors. The sensors 126 may include, for example, a carbon monoxide (CO) sensor 142, a portion detection sensor 144, an information sensor 146, a motion sensor 148, and the like.

[082] As described herein, the term "biomarker" can be used interchangeably with the term "biometric data." The biomarker may be body temperature, such as core body temperature and/or skin temperature. A sensor that may be included in sensors 126 may be a body temperature detection system capable of measuring body temperature data, including temperature, emitted frequency spectra, and/or the like. The body temperature detection measurement system may measure body temperature data using some combination of thermometers and/or radio telemetry. For example, the body temperature detection system may include a wearable antenna that measures body radiant spectra. In another example, the body temperature detection system may include a wearable patch that measures body temperature data, such as skin temperature data. The body temperature detection system may be a smartwatch 206 and/or may be associated with a smartwatch 206.

[083] The body temperature detection system may calculate a body temperature using body temperature data. The body temperature detection system may transmit the calculated body temperature to the NRT device 100 and/or a device that may include the NRT and/or a behavioral application. The body temperature data may be tracked over time and may be displayed to the user.

[084] The body temperature detection system may process body temperature data locally or send the data to a data processing unit and/or a computing system, such as computing resource 212. Based on the measured temperature data, the body temperature detection system may determine biomarkers associated with body temperature, characteristic fluctuations, climatic activity, physical activity, urge to consume nicotine and/or nicotine consumption.

[085] For example, a body temperature detection system may determine that skin temperature has increased over a period of time before the user begins smoking a cigarette, e-cigarette, consuming tobacco, and/or consuming nicotine, and may determine that skin temperature has decreased after the user begins smoking a cigarette, e-cigarette, consuming tobacco, and/or consuming nicotine. Nicotine consumption may include nicotine from cigarettes, tobacco products, nicotine e-cigarettes, and/or nicotine from an alternative source such as a body patch, chewing gum, nasal spray, inhaler, lozenges/tablets, oral spray, and the like. In another example, a body temperature detection system may determine physical activities using measured fluctuations in body temperature.

[086] The biomarker may be maximal oxygen consumption (VO2). A sensor that may be included in sensors 126 may be a V02 max determination system that can measure VO2 max data, including oxygen uptake, heart rate, and/or movement speed. The V02 max determination system may measure VO2 max data during physical activity, including running and/or walking.

[087] The VO2 max determination system may be included in a portable device, such as a smartwatch 206. The VO2 max measurement system may be the smartwatch 206 and/or may be associated with the smartwatch 206. The VO2 max determination system may process the VO2 max data locally or may transmit the data to a data processing unit (e.g., to the processor 132) and/or a computing system, such as the computing resource 212.

[088] Based on the measured VO2 max data, biomarkers can be derived, determined, and/or calculated, including a quantitative VO2 max metric, an estimate of VO2 max, physical activity, and/or physical activity intensity. The VO2 max determination system can select the correct VO2 max data measurements at the right time segments to calculate accurate VO2 max information. Based on the VO2 max information, the measurement system can detect dominant cardiac, vascular, and/or respiratory factors. Based on the VO2 max information, smoking urge can be predicted.

[089] The biomarker may be physical activity or may be associated with physical activity. A sensor that may be included in sensors 126 may be a physical activity detection system that can measure physical activity data, including heart rate, movement, position, posture, range of motion, speed of movement, and/or pace of movement. The physical activity detection system may measure physical activity data using devices such as an accelerometer, magnetometer, gyroscope, global positioning system (GPS), PPG, and/or EKG. The physical activity detection system may include a portable device, such as smartwatch 206. The portable device for detecting physical activity may include, but is not limited to, a watch, cuff, vest, glove, belt, headband, shoes, and/or clothing. The physical activity determination system may be a smart watch 206 and/or may be associated with the smart watch 206. The physical activity determination system may process the physical activity data locally or transmit the data to a data processing unit (for example, a processor 132) and/or a computing system, such as a computing resource 212.

[090] Based on the measured physical activity data, the physical activity determination system may determine physical biomarkers related to the activity, including, but not limited to, physical activity, physical activity intensity, physical activity frequency, and/or physical activity duration. The physical activity determination system may generate aggregated physical activity data based on the physical activity information.

[091] For example, the physical activity determination system may send physical activity information to the computing resource 212. Based on the physical activity information, the computing resource 212 may generate aggregated activity data, may associate activities with smoking urges, and/or may associate activities with nicotine consumption. The computing system may store the physical activity information in user profiles. The computing system may display the physical activity information in graphical form. The computing system may select certain physical activity information and display the information as a whole or individually.

[092] The biomarker may be a respiratory rate. A sensor that may be included in sensors 126 may be a respiratory detection system that can measure respiratory rate data, including inhalation, exhalation, chest cavity movement, and/or air flow. The respiratory detection system may measure respiratory rate data by mechanical, electrical, and/or optical means (e.g., by monitoring blood vessel dilation using light). The respiratory detection system may measure respiratory data mechanically by detecting chest cavity movement. Two or more electrodes placed on the chest may measure the changing distance between the electrodes to determine the expansion and contraction of the chest cavity during the respiratory cycle. The respiratory detection system may include a body patch. The respiratory detection system may measure respiratory data acoustically using a microphone to record sounds generated by air flow. The respiratory detection system may measure respiratory data optically by monitoring blood vessel dilation and contraction using light. The breathing detection system may be a smartwatch 206 and/or may be associated with the smartwatch 206. The breathing detection system may process breathing data locally or transmit data to a data processing unit (e.g., processor 132) and/or a computing system, such as computing resource 212.

[093] Based on the measured respiration data, the respiration detection system can generate respiration-related biomarkers, including respiration rate, respiration pattern, and/or respiration depth. Based on the respiration rate data, the respiration detection system can generate a respiration quality assessment. Based on the respiration rate data, the respiration detection system can determine respiration-related biomarkers, including shortness of breath, pain, nicotine cravings, and/or nicotine consumption.

[094] The biomarker may be a blood pressure measure. A sensor that may be included in sensors 126 may be a blood pressure determination system that can measure blood pressure data, including blood vessel diameter, tissue volume, and/or pulse transit time. The blood pressure determination system may measure blood pressure data using oscillometric measurements, ultrasound patches, photoplethysmography, and/or arterial tonometry. The blood pressure determination system using photoplethysmography may include a photodetector for measuring light scattered by a tissue area illuminated by light from an optical emitter. In the blood pressure determination system using arterial tonometry, arterial wall applanation may be used. The blood pressure determination system may include an inflatable cuff, a cuff, a watch, and/or an ultrasound patch. The blood pressure determination system may be a smartwatch 206 and/or may be associated with a smartwatch 206.

[095] Based on the measured blood pressure data, the blood pressure detection system may quantify blood pressure-related biomarkers, including systolic blood pressure, diastolic blood pressure, and/or pulse transit time. The blood pressure detection system may use blood pressure-related biomarkers to detect nicotine cravings and/or nicotine consumption. For example, a user who smokes 1 cigarette per day may be associated with a higher (0.21 bpm; 95% confidence interval, 0.19, 0.24) resting heart rate, slightly elevated diastolic blood pressure (0.05 mmHg; 95% confidence interval, 0.02, 0.08), systolic blood pressure (0.08 mmHg; 95% confidence interval, 0.03, 0.13). The blood pressure determination system may process the blood pressure data locally or transmit the data to a data processing unit (e.g., processor 132) and/or a computing system, such as computing resource 212.

[096] The biomarker may be heart rate variability (HRV). A sensor that may be included in sensors 126 may be an HRV determination system that can measure HRV data, including heart sounds and/or the duration between consecutive heartbeats. HRV data may include the standard deviation of the duration of intervals between normal (NN) sinus-triggered heartbeats (SDNN), the square root of the mean sum of squared differences between adjacent NN intervals (RMSSD), the number of pairs of NN intervals that differ by more than 50 milliseconds (NN50), the proportion of NN50 intervals divided by the total number of NN intervals (pNN50), low-frequency (LF) HR oscillations, ultra-low-frequency (ULF) HR oscillations, very-low-frequency (VLF) HR oscillations, high-frequency (HF) HR oscillations, etc.

[097] The HRV determination system may measure HRV data by electrical or optical means. The HRV determination system may measure HR variability data using ECG tapes. The HRV determination system may use ECG tapes to measure variability in the intervals of time between R peaks in a QRS complex. The HRV determination system may measure HR variability by optical means using PPG tapes. The HRV determination system may use PPG tapes to measure variability in the intervals of time between heartbeats. The HRV determination system may measure HRV data over a predetermined time interval. The HRV determination system may include a portable device, including a ring, a watch, a cuff, and/or a patch. The HRV determination system may be a smartwatch 206.

[098] Based on the HRV data, the HRV determination system may determine biomarkers associated with HRV that may indicate cardiovascular health, changes in HRV, nutrition monitoring, anxiety levels, physical activity, urges to consume nicotine, and/or nicotine consumption. For example, the HRV determination system may determine that the cardiovascular system is healthy based on high HRV. In another example, the HRV determination system may determine an increase in the HRV frequency domain index, which may indicate smoking cessation. In another example, the HRV determination system may determine a biomarker that indicates that the user has successfully quit smoking and/or reduced nicotine consumption, such as by determining a higher SDNN, a higher RMSSD, a higher pNN50, a higher LF, and/or a higher HF. The HRV determination system may process the HRV data locally or transmit the data to a data processing unit (e.g., to processor 132) and/or a computing system, such as computing resource 212.

[099] The biomarker may be a heart rate (HR). A sensor that may be included in sensors 126 may be an HR detection system that can measure HR data, including cardiac chamber expansion, cardiac chamber contraction, and/or reflected light. The HR detection system may use an ECG and/or PPG to measure HR data. For example, an HR detection system using an ECG may include a radio transmitter, a receiver, and one or more electrodes. The radio transmitter and receiver may detect voltages between electrodes located on the skin due to expansion and contraction of the cardiac chambers. The HR detection system may calculate HR using the measured voltage. For example, an HR detection system using PPG may direct green light onto the skin and detect reflected light using a photodetector. The HR detection system may calculate HR using the measured intensity of light absorbed by the blood over a period of time. The heart rate detection system may include a watch, a wearable elastic band, a body patch, a bracelet, clothing, a cuff, an earphone, and/or a headband. The heart rate detection system may be a smartwatch 206 and/or may be associated with the smartwatch 206.

[100] Based on the measured HR data, the HR detection system may calculate biomarkers associated with HR, including HR, HR variability, and/or average HR. Based on the HR data, the HR detection system may determine biomarkers that may indicate stress, pain, nicotine cravings, and/or nicotine consumption. The HR detection system may determine when the user's resting HR exceeds a threshold. For example, the HR detection system may determine that the user may have a higher resting HR, which may indicate that the user may not have quit smoking and/or reduced nicotine consumption. In another example, the HR detection system may determine that the user may continue to smoke and/or consume nicotine, or may be a smoker and/or nicotine user, by determining that the user has a slower increase in HR during exercise, a lower maximum HR, a lower heart rate reserve, and/or a slower decrease in HR during recovery. The heart rate determination system may process the heart rate data locally or transmit the data to a data processing unit (e.g., processor 132) and/or a computing system, such as computing resource 212.

[101] The biomarker may be a galvanic skin reflex. A sensor that may be included in sensors 126 may be a GSR detection system that can measure skin conductivity data, including electrical conductivity. The GSR detection system may comprise one or more electrodes. The GSR detection system may measure electrical conductivity by applying a voltage to the electrodes. The electrodes may comprise silver or silver chloride. The GSR detection system may be placed on one or more fingers. For example, the GSR detection system may include a portable device that may include one or more sensors that can be attached to one or more fingers. GSR data may vary depending on sweat levels. The GSR determination system may be a smartwatch 206 and/or may be associated with the smartwatch 206. The GSR determination system may process the GSR data locally or transmit the data to a data processing unit (for example, to the processor 132) and/or a computing system, such as the computing resource 212.

[102] Based on the GSR data, the GSR determination system may calculate GSR-related biomarkers that may indicate levels of single activity, urge to consume nicotine, and/or nicotine intake. For example, a GSR determination system based on high skin conductance may determine high levels of single activity. In another example, the GSR determination system may determine a smoking event by determining an increase in GSR measurement over time prior to the smoking event, a decrease in GSR during the smoking event, and/or an increase in GSR over time following the smoking event.

[103] The CO sensor 142 may include any measuring device suitable for determining the presence and/or concentration of CO near the sensor. The CO sensor may be a biomimetic type CO sensor, an electrochemical type CO sensor, a semiconductor type CO sensor, or the like. The CO sensor 142 may transmit information about the presence and/or concentration of CO to the controller 122 via the input/output devices 136. In examples, the CO sensor 142 may determine the level of CO in the air exhaled by a smoker engaged in a smoking cessation and/or nicotine consumption procedure. The level determined by the CO sensor 142 may indicate a numerical characteristic of smoking behavior. For example, CO levels in the exhaled air below about 9 ppm and/or about 4 ppm or lower may indicate general abstinence due to smoking cessation.

[104] The portion detection sensor 144 may be any sensor suitable for detecting the dispensed portion. In examples, a mechanical structure may transmit a force and/or movement that results in dispensing according to the readings of the sensor 144. The sensor 144 may include a magnetic field sensor, such as a small-scale microelectromechanical system (MEMS) magnetic field sensor, a contact closure, a reed switch, a potentiometer, a force sensor, a push button, or the like. In examples, the dispensing device may employ an electrically controlled dispensing mechanism, such as an electric pump with variable output. The portion detection sensor 144 may include an algorithm for logically determining the fact of dispensing a portion. The portion detection sensor 144 may transmit any information suitable for determining the dispensing of a portion. For example, the portion detection sensor 144 may output a signal in the form of a voltage level indicating a portion, a logical trigger, a numerical number of portions, or an analog signal that can be processed (e.g., using a low-pass filter) to determine that the signal indicates to the controller via the input/output devices 136 that a portion has been delivered. The portion detection sensor 144 may have a level of accuracy or resolution that allows the controller 122 to determine the duration of the response. For example, the analog signal may be processed using an analog-to-digital converter (ADC), processed using a hysteresis threshold, and the resulting duration of the condition may be determined.

[105] The information sensor 146 may include any sensor suitable for reading stored information. In an embedded application with a physical platform, the information may be encoded and stored on various media that may be included in aspects of the physical configuration. For example, information about the identity, concentration, volume, etc. of a vial with a nicotine formulation may be encoded and stored in a way that is physically associated with the vial itself. In examples, the information may be encoded on the vial in a quick read (QR) code, in a readable integrated circuit such as a single-wire identification integrated circuit, in a near field communication (NFC) tag, in a physical/mechanical key, in a subscriber identity module (SIM card), or the like. When the vial is inserted into the device 100, the information sensor 146 may read the information encoded on the vial. Controller 122 can use this information for cross-referencing and/or authenticating the vial. In one example, the function of information sensor 146 can be implemented using logic circuits and programming for receiving information encrypted in a QR code from a paired QR code reader in a smartphone. A user can pair the smartphone with device 100 via Bluetooth. The user can use the phone to scan the QR code, and this phone can transmit the information to controller 122 via communication devices 124. In examples, information sensor 146 can also be suitable for recording information associated with the vial on the same storage medium, for example, using a readable/writable NFC tag.

[106] After receiving information using the information sensor 146 and transmitting it to the processor 132, this processor 132 can identify the vial and verify its authenticity. The processor can execute any digital algorithm suitable for identification and/or authentication, such as public-key cryptographic algorithms, traditional cryptographic algorithms, security token processing, remote database searching, blockchain processing, and/or the like.

[107] The motion sensor 148 may include any sensor suitable for detecting relative motion, acceleration, velocity, orientation, and/or the like of the device 100. The motion sensor 148 may include a piezoelectric, piezoresistive, and/or capacitive component for converting physical motion into an electrical signal. For example, the motion sensor 148 may include an accelerometer. The motion sensor 148 may include a microelectromechanical system (MEMS), such as a MEMS thermal accelerometer. The motion sensor 148 may be suitable for detecting repetitive or periodic motion, such as restlessness, in a user possessing the device 100. The motion sensor 148 may transmit this information via the input/output devices 136 to the processor 132 for processing. The detection of restlessness in a user may indicate, for example, the onset of nicotine cravings.

[108] The device 100 may include one or more actuators 128 for transmitting feedback to the user and/or for initiating a mechanical action. The actuators 128 may include a locking mechanism 150, a light-emitting diode driver 152, and the like. Other actuators 128 may include haptic feedback drivers, audio output drivers, heating element drivers, and/or the like.

[109] The locking mechanism 150 may include any electromechanical device suitable for providing, upon command of the controller 122, mechanical interaction with the operation of the dispenser. For example, the locking mechanism 150 may include an electromagnet controlled by the processor 132 via the input/output device 136. The electromagnet may cause the movement of a mechanical latch, which may be configured to enable/disable the actuation of the dispenser. Similarly, the locking mechanism 150 may include a piezoelectric squiggle motor, which may be controlled by the processor 132 via the input/output devices 136 to rotate the mechanical latch inward and outward relative to the path of movement of the dispenser drive carriage. The locking mechanism 150 may include a stepper motor, a unipolar motor, a bipolar motor, a servo motor, and/or the like.

[110] The LED driver 152 may include any circuit suitable for controlling the illumination of the LED. The LED driver 152 may be configured to be controlled by the processor 132 via the input/output devices 136. The LED driver 152 may be used to indicate status information to the user. The LED driver 152 may include a multi-color LED driver.

[111] The power management subsystem 130 may include a circuit suitable for managing power and distributing power between the components 100. The power management subsystem 130 may include, for example, a battery, a battery charger, and a DC power distribution system. The power management subsystem 130 may communicate with the processor 132 via the input/output devices 136 to provide information such as the charge state of the battery. The power management subsystem 130 may include a replaceable battery and/or a physical connector for charging the battery from an external source.

[112] FIG. 2A is a block diagram of an example system 200 for supporting an NRT device 202. The NRT device 202 may be a nicotine dispenser with sensing, data communication, actuation, and processing functions, such as, for example, the NRT device 100 described in FIGS. 1A-C. The system 200 may include the NRT device 202, a smartphone 204 with an appropriate NRT application and/or behavioral support application, a smartwatch 206 with an appropriate NRT application and/or behavioral support application, a wireless access network 208, a communication network 210, and a computing resource 212.

[113] Smartphone 204 may include an NRT application and/or a behavioral support application. Smartphone 204 may provide a primary user interface for providing a personalized smoking cessation procedure. Smartphone 204 may provide passive or active tracking and/or location services.

[114] The smartwatch 206 may provide a device user interface. The smartwatch 206 may also provide biometric feedback and data such as heart rate and/or heart rate variability. The smartwatch 206 may perform activity tracking and provide activity information. In examples, the smartwatch 206 may include a galvanic skin reflex sensor.

[115] The device 202 may include a nicotine replacement therapy dispenser, a CO sensor, an electronically controlled locking mechanism, a replaceable vial with a nicotine composition, a vial identification and/or authentication function, an NRT activation/use detection function, a restlessness detection function, a geofencing function, and/or the like.

[116] Computing resources 212 may provide data storage and processing functionality. Computing resources 212 may receive and analyze behavioral data. For example, computing resources 212 may receive and analyze behavioral data to identify predicted endpoints for a procedure, such as, for example, heart rate, heart rate variability, and/or CO levels.

[117] The components of the system 200 may communicate with each other via various communication protocols. The device 202 may communicate with the smartphone 204, for example, via the Bluetooth wireless link 214. The smartwatch 206 may communicate with the smartphone 204 via the Bluetooth wireless link 216. The smartphone 204 may communicate with the wireless access network 208, for example, via the wireless link 218. The wireless link 218 may include any suitable wireless protocol, such as a wireless protocol of the 802.11 standard, such as Wi-Fi, GSM, 4G LTE, 5G and 5G NR, and any number of IoT mobile communication protocols.

[118] Communication network 210 may include a long-distance data network, such as a private corporate network, a virtual private network (VPN), a public commercial network, network interconnections such as the Internet, or the like. Communication network 210 may provide connectivity to computing resource 212.

[119] Computing resource 212 may include any server resources suitable for remote processing and/or storage of information. For example, computing resource 212 may include a server, a cloud server, a data center, a virtual machine server, etc. In examples, device 202 may communicate with computing resource 212 via smartphone 204. And in examples, device 202 may communicate with computing resource 212 via its own wireless communication link 220.

[120] System 200 may provide for collecting and processing information related to a smoking cessation procedure. System 200 may provide for receiving data on behavioral support for a smoking cessation procedure. For example, a CO measurement sensor integrated into device 202 may provide convenient CO measurements taken during NRT use. The measurements may be sent and processed via an NRT application and/or a behavioral support application in smartphone 204 and/or via computing resource 212. Analysis of the data provides for the identification of a smoking relapse in a user. In examples, activity data from smartwatch 206, from a motion sensor in device 202 and/or activity tracking data via smartphone 204 may be used to set dynamic thresholds for CO levels. In general, CO is eliminated from exhaled air, and the rate at which this occurs depends on the intensity of ventilation of the lungs of a particular person. Accordingly, the half-life of CO may be a function of the intensity of recent physical activity. Activity data can be used to more accurately interpret CO levels in specific measurements.

[121] Similarly, the NRT application and/or the behavioral support application in the smartphone 204 and/or the computer resources 212 may analyze data from the activation sensor on the device 202 indicating the use of NRT. This information may be used to assess compliance with the smoking cessation program and may be used to activate the user feedback loop to provide notifications and stimulation. The Bluetooth communication link 214 between the device 202 and the smartphone 204 may provide the ability to use the CO level and NRT use data to provide immediate feedback to the user during the implementation of the smoking cessation program.

[122] In examples, other related data, such as position, time stamps, serving number, or actuation duration, may be captured and processed in conjunction with CO levels and NRT application to identify patterns of successful and unsuccessful quitting behaviors and provide timely and relevant feedback to the user. This data may be used to train a machine learning algorithm that can determine appropriate action selection and timing. For example, position data may be used in conjunction with CO levels and NRT application to identify specific triggers and/or habits associated with smoking and/or urges to smoke. These identified position triggers may be used to provide timely feedback and stimulation to the user.

[123] The collected data can be used to enforce nicotine intake restrictions to further enhance the effectiveness of the smoking cessation program and/or for safety. For example, position data can be used to activate a locking mechanism to prevent the dispensing of a nicotine formulation. For example, the collected data regarding the identification and authentication of a vial of nicotine formulation can be used to ensure that genuine vials and/or vials containing the nicotine formulation at the proper concentration can be used, and that non-genuine vials and/or vials containing the nicotine formulation at the wrong concentration cannot be used for a particular user.

[124] FIG. 2B shows an example of a message flow chart in an example system 200. For example, system 200 may include data communication and processing functions for functions such as initialization and authentication of the dispensing device and the NRT application and/or the behavioral support application; collection of data from a smart watch and/or one or more sensors associated with the dispensing device 202; cloud-based management, launching, sending notifications, etc., application-based management, sending messages and notifications, etc.; and/or local management of the dispensing device 202.

[125] Initialization and authentication messages 222 may be exchanged between device 202 and smartphone 204. Initialization and authentication messages 224 may be exchanged between computing resource 212 and smartphone 204. For example, a new user may create a user account via smartphone 204. Account information may be processed by computing resource 212. The new user may initialize dispensing device 202 and/or wish to verify the authenticity of a vial with a nicotine composition. This information may be transmitted via messaging 222 with smartphone 204 and then via messaging 224 with computing resources 212. Response information about user accounts, vial authentication, etc. may be sent in the form of messages back to device 202.

[126] The data collection function may include transmitting messages 226 from the smartwatch 206 and/or to the smartphone 204. Such messaging may include transmitting information such as activity information, heart rate, heart rate variability, and other biometric information. The data collection function may include transmitting messages 228 from the device 202 to the smartphone 204. Such messaging 228 may include transmitting information about the operation of the device such as the time/date/position of activation, duration of activation, motion, CO level, and the like. In examples, the smartphone 204 may aggregate the exchange of messages 226, 228, process them locally, and/or transmit them or information related to them to the computing resources 212 via the exchange of messages 230.

[127] The system 200 provides cloud-based control functions, application control functions, and local control functions. For example, information related to the smoking cessation procedure, such as pre-alert/incentive for the user, adaptive updating of the procedure, mechanical locks, and other feedback, can be provided to the smartphone 204 by the computing resources 212 via messaging 232 and, if necessary, from the smartphone 204 to the device 202 via messaging 234. The computing resource 212 can directly communicate with the device 202 via a direct wireless connection 230 via an exchange of native messages (not shown).

[128] In examples, information related to the smoking cessation procedure may be generated from the NRT application and/or the behavioral support application displayed directly (and/or displayed via the smartwatch 206). Information related to the smoking cessation procedure may be transmitted to the device 202 via messaging 236.

[129] In examples, device 202 may provide local control via its own local processor. Internal system calls and/or local messaging are shown as local loop 238.

[130] FIG. 3A shows an example of a schematic view of a device that may be a smart NRT device 100. The device 100 may include a housing 341, a dispenser 337 configured to be slidably received into the housing 341, and a cover 308 that is attached to the housing 341.

[131] The housing 341 may be an elongated hollow housing, open at one end, and it may have an oval cross-section. The housing 341 may have a curved front wall 351 and a curved rear wall 353. The curved front wall 351 may have a cutout so that a cover 308 can be attached to the housing 341. A mouthpiece 342 (see FIG. 3B) may be provided at one end of the housing 341.

[132] An elongated, substantially vertical central groove 311 may be provided in the cover 308. A pair of smaller square openings 310a and 310c (see FIG. 5A) may be located at the upper end of the central groove 311, with the openings 310a and 310c located on each side of the central groove 311, diametrically opposite to each other. Similarly, a second pair of corresponding square openings 310b and 310d may be located at the lower end of the central groove 311 so that four openings 310a, 310b, 310c and 310d are located at the four corners of an imaginary square (see FIG. 5A).

[133] FIG. 3B shows another example of a schematic view of the device. The dispenser head 339 may include a top portion 304, a face portion 306, a spring member 302, and a transfer plate 300.

[134] The face portion 306 may have a D-shaped cross-section. The face portion 306 may be configured to engage with a telescopic extension by sliding within the housing 341. The face portion 306 may have a curved front wall 309 and a flat rear wall 307. The curved front wall 309 and the flat rear wall 307 of the face portion 306 may be mated with one or more walls of the housing 341.

[135] The upper section of the flat rear wall 307 of the front portion 306 may be cut to form an opening 305 of arbitrary shape. The lower section of the flat rear wall 307 may be made of a transparent material and may correspond to the opening 305 of arbitrary shape in the main portion 338 of the housing 341. Through the lower section of the flat rear wall 307 and the opening 305 of arbitrary shape, a portion of the vial 324 may be visible when the vial 324 is contained within the housing 341. For example, this is necessary so that the QR code 323 is visible through the opening 350 of arbitrary shape. In this way, another device can scan the QR code, for example for authentication, when the vial 324 is located in the housing 341.

[136] The lower portion of the curved front wall 309 may be cut out. A pair of sliding projections may be provided along the lower edge of the outer surface of the rear wall of the front portion 306. The pair of sliding projections may slidably engage with guide grooves on the rear wall of the main portion 338 of the housing 341. In addition, a pair of inclined projections may be provided along the upper edge of the inner surface of the rear wall of the main portion 338 of the housing. This pair of inclined projections may be provided for locking engagement with inclined members that may be provided on the coupling 320.

[137] An outlet 303 may be provided in the curved front wall 309. The outlet 303, which may be any spray outlet, is in fluid communication with a feed channel that may be formed integrally with the face 306 and may extend back into the opening 303.

[138] The top portion 304 may comprise a flat rear wall that may correspond to a cut-out section of the flat rear wall 307 of the front portion 306. The top portion 304 may have a cantilevered top that may extend beyond the top edge of the rear wall and may have a D-shaped cross-section corresponding to the cross-section of the front portion 306.

[139] The upper portion 304 may be received into the opening of the front portion 306 so that the rear wall of the upper portion 304 and the flat rear wall 307 form a peripheral edge. The rear wall of the upper portion 304 may form a rib-shaped stop.

[140] The rear wall of the top portion 304 may comprise an arched window 312. The upper edge of the arched window 312 may be provided with a crescent-shaped bead recessed relative to the rear wall of the top portion 304. The straight lower edge of the arched window 312 may be provided with a hinged arched frame on the inside of the rear wall of the top portion 304, which may be attached along the lower edge by means of a hinge.

[141] The spring member 302 may be attached to the arched window portion 312 and the transfer plate 300. For example, the spring member may be used to hold the transfer plate 300 within the arched window 312.

[142] The transfer plate 300 may have a contour shape identical to the shape of the arched window 312. The inner surface of the transfer plate 300 may comprise guide channels that can be used to slide into engagement with the frame section of the upper part 304.

[143] The transfer plate 300 may be slidably mounted to the hinge frame of the upper part 304. For example, the guide channels of the transfer plate 300 may contact a section of the frame of the upper part 304. The transfer plate 300 may be attached to the upper arm of the spring element 302, and the spring element 302 may operate to elastically bias the transfer plate 300 into a desired position.

[144] The cover 308 may be configured to be attached to the main portion 338 of the housing 341. The cover 308 has one or more guide projections that can be slidably engaged with the main portion 338 of the housing so that the cover 308 can be snapped into place. The cover 308 may cover the dispenser 337 and the dispenser head 339 when the dispenser head 339 is in the inoperative position. The cover 308 may not cover the dispenser head 339 when the dispenser head 339 is in the operative position. The cover 308 may allow the dispenser head 339 to telescope by sliding along an axis relative to the main portion 338 of the housing. For example, the cover 308 may be configured to telescope the dispenser head 339 by sliding from the main body portion 338 so that the dispenser head 339 may be in the operating position for dispensing.

[145] The dispenser 337 comprises a number of subcomponents: a dispenser body in the form of a vial 324, a dispensing mechanism, a coupling 320, a locking lever 322 and a drive element. The dispensing mechanism may be in the form of a pump mechanism 400. The coupling 320 may be configured to attach the pump mechanism 400 to the vial 324. The drive element may be a dispenser head 339.

[146] The vial 324 may comprise a main body portion that may have a D-shaped cross-section. The main body portion may have a dispensing chamber that contains a substance. For example, the vial 324 may contain a nicotine composition. The vial 324 may have a hollow cylindrical neck portion that may be an open mouth. The open mouth may provide a pump mechanism 400 for dispensing the nicotine composition located within the vial 324.

[147] The vial 324 may include a QR code 323. The QR code 323 may be used for authentication. For example, the QR code 323 may be used to authenticate the vial so that the device 100 is allowed to use the vial 324. As further described herein, the device 100 may employ a locking mechanism that prevents the use of the vial 324 when the device 100 fails to authenticate the vial 324, for example, using the QR code 323.

[148] The QR code 323 may be used for informational purposes. For example, the QR code 323 may provide information about the concentration of the nicotine composition, the volume of the nicotine composition contained in the vial 324, the amount of nicotine in a portion of the nicotine composition, the expiration date of the nicotine composition, and/or the like.

[149] Vial 324 may include chip 325. Vial 324 may include a small recess for chip 325 of appropriate thickness. Chip 325 may be a near field communication (NFC) device, a wire trace, an electronic integrated circuit, and/or the like. Chip 325 may comprise a housing or a flexible printed circuit board substrate. Device 100 may provide a mechanism that can contact or detect chip 325 such that device 100 can read and/or write information to chip 325.

[150] The chip 325 may be used for authentication. For example, the chip 325 may be used to authenticate the vial so that the device 100 is allowed to use the vial 324. As further described herein, the device 100 may employ a locking mechanism that prevents the use of the vial 324 when the device 100 fails to authenticate the vial 324, for example, using the chip 325.

[151] The microcircuit 325 may be used for information purposes. For example, the microcircuit 325 may provide information about the concentration of the nicotine composition, the volume of the nicotine composition contained in the vial 324, the amount of nicotine in a portion of the nicotine composition, the expiration date of the nicotine composition, and/or the like.

[152] The vial 324 may be formed from any suitable material using any suitable method, such as by blow molding a plastic material or the like. The vial 324 may retain the nicotine formulation and may be formed from a nicotine-inert material that may not absorb or react with the nicotine formulation. The vial 324 may be made from a material capable of providing a barrier to the migration of oxygen and water. Vial 324 may be made from glass, a copolymer of acrylonitrile and methyl acrylate, a copolymer of cyclic olefin (COC), and combinations thereof, and/or the like. Other suitable materials from which vial 324 may be formed include materials selected from polymers based on dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalene-dicarboxylic acid monomers, such as polyethylene naphthalate (PEN) and polytrimethylene naphthalate (PTN), liquid crystal polymers (LCP), preferably LCPs containing hydroxybenzoic acid and hydroxynaphthalene acid, and combinations thereof. Suitable materials also include materials blended with one or more other polymers selected from one or more of polyacrylonitrile (PAN), polyamide (PA), polyvinylidene chloride (PVDC), fluoropolymers, ethylene vinyl alcohol copolymer (EVOH), polyvinyl alcohol (PVA), ionomers, polyethylene (PE), polypropylene (PP), and polyethylene terephthalate (PET).

[153] The vial 324 may include a neck portion that may comprise a peripheral flange. The peripheral flange may be rectangular in shape, but may include a curved leading edge that may conform to the wall of the housing 341. The leading edge of the vial may include a guide projection and/or a pair of seating projections, respectively, located on opposite shorter sides of the substantially rectangular peripheral flange.

[154] The dispensing mechanism may be in the form of a pumping mechanism 400. The pumping mechanism 400 may be a manual control mechanism or an electronically controlled mechanism. For example, the pumping mechanism 400 may be a controlled electric pump.

[155] FIG. 3C shows an example of a pumping mechanism that may be used by a smart NRT device. Pumping mechanism 400 may include a suction tube for drawing fluid from a cavity in the main body of vial 324; a cylindrical pump body that may provide an internal pumping chamber in communication with the suction tube; and a piston member 408 mounted so as to move within the pumping chamber, against the force of a biasing member 410 in the form of a coil spring, for forcing the contents of the pumping chamber upward through an opening in piston member 408 and out through a hollow rod 404 connected to piston member 408.

[156] The pump mechanism 400 may comprise a pump housing formed by connecting the pump chamber 414 to the annular cap 402. The pump mechanism 400 may provide an internal pump chamber within the pump chamber 414. The pump chamber 414 may communicate with a suction tube. A check valve 412 may be located within the pump chamber 414. The check valve 412 allows contents to be received from the vial 324 into the pump chamber 414 through the suction tube. The check valve 412 is capable of preventing the contents from moving from the interior of the pump chamber 414 through the suction tube and into the vial 324.

[157] The piston member 408 may be movably mounted within the pump chamber 414. The piston member 408 may be positioned against the biasing member 410 and in contact with the check valve 412 so that the piston member may force the contents of the pump chamber 414 through the opening in the piston member 408 and discharge it out through the hollow rod 404. The hollow rod 404 may be connected to the piston member 408. The piston member 408 may be held in position within the pump chamber 414 by means of the piston shoulder 406. The piston flange 406 may be received inside the annular cap 402. The annular cap 402 may have an opening through which the upper portion of the hollow rod 404 may pass, and the annular cap 402 may be connected to the lower portion of the hollow rod 404.

[158] As also shown in FIG. 3B, the pump body may be seated on the rim of the mouth of the vial 324 so that the pump body can form a seal with the mouth of the vial 324 and the suction tube extends downward into the dispensing chamber of the vial 324.

[159] The coupling 320 may press the pumping mechanism 400 against the vial 324. For example, the coupling 320 may press the pumping mechanism 400 against the mouth of the vial 324 and may help seal the vial 324 during use. The coupling 320 may comprise an annular portion and a pair of diametrically opposed arms protruding from the annular portion. The arm (for example, each arm) may have an opening at the lower end. The coupling 320 may have a pair of additional tabs that may end in corresponding inclined members for locking the dispenser head 339 on the coupling 320.

[160] To press the pump mechanism 400 against the vial 324, the pump housing can be seated on the rim of the mouth of the vial 324 and the coupling 320 can be pressed from above onto the pump housing so that the arms of the coupling 320 extend downwards on both sides of the pump housing. The arms of the coupling 320 can be elastically deformed by the sides of the pump housing and can engage with one or more seating projections of the vial 324 in a locking connection. The pump housing can be clamped between the rim of the mouth of the vial 324 and the annular portion of the coupling 320.

[161] The locking lever 322 may comprise a pair of tabs extending from the ends of a connecting hook that extends perpendicular to the pair of tabs. A tab (for example, each tab) may comprise a locking element in the form of a projecting leg located at the distal end of the tab, an inwardly projecting ear located at the bend of the corresponding tab. The tab may comprise an element that may be elastic, extending backward from the back of the bend of the tab and ending opposite the heel of the projecting leg. The locking element, which may be elastic, may connect with the square holes 310a-d to lock the device 100 in an operating position (for example, an unlocked position) or a non-operating position (for example, a locked position). Locking may be accomplished using a locking connection. For example, the locking elements of the locking lever 322 can be connected to the square hole 310a and the square hole 310c to lock the device 100 in the working position, in which the dispenser head 339 is in a position that extends beyond the main part 338 of the housing. In another example, the locking elements of the locking lever 322 can be connected to the square hole 310b and the square hole 310d to lock the device 100 in the non-working position, in which the dispenser head 339 can be located flush with the edge of the main part 338 of the housing or below it.

[162] The tab of the locking lever 322 may be elastic to implement a locking connection. For example, by rotatably engaging the ears of the locking lever 322 with round holes on the arms of the coupling 320, the locking lever 322 can be attached to the coupling 320. The locking lever 322 can be attached to the coupling 320 in such a way that the locking lever 322 can rotate relative to the coupling 320 around an axis passing through the ears of the locking lever 322.

[163] The dispenser head 339 may be movable relative to the vial 324 to actuate the pump mechanism 400. For example, the dispenser head 339 may be mounted on the pump mechanism 400 via elastic elements with the ability to move relative to the vial 324 against the force of the coil spring to drive the pump mechanism 400 and dispense the contents of the vial 224 through the outlet 303. The actuator of the dispenser head 339 may cause the locking lever 322 and/or the vial 324 to come into contact with the carriage 328 to effect the movement of the carriage 328. For example, the carriage 328 may move in a direction relative to the movement of the actuator, the movement of the vial 324 and/or the movement of the locking lever 322. The actuator of the dispenser head 339 may cause the carriage 328 to move, which can be detected by the electronic device 600. For example, the electronic device 600 can detect the carriage 328, which may be magnetic, or may contain magnets, or may move in such a way that it may indicate the release of a dose of nicotine from vial 324.

[164] To install the dispenser head 339, the dispenser head 339 can be pressed against the pump mechanism 400, for example, so that the lower tube of the feed channel of the dispenser head 339 can engage the hollow rod of the piston element to form a closed channel between the vial 324 and the outlet pipe 303, through the internal pump chamber in the pump mechanism. After pressing the dispenser head 339 against the pump mechanism, the engagement of the inclined projections and the inclined members can lead to a locking connection between the rear wall 307 and the coupling 320, and the inclined projections and the inclined members can subsequently limit the upward movement of the dispenser head 339 relative to the coupling 320 and the vial 324.

[165] The housing 341 may comprise a mouthpiece 342, a main body 338, a housing frame 336, a carbon monoxide sensor 348, a port 332, a battery 326, an electronic device 600, a carriage frame 329, and a carriage 328.

[166] The frame 336 of the housing may be attached to the main part 338 of the housing, for example, using a screw. The frame 336 of the housing may have a hollow cylindrical neck portion that may provide an open mouth at one end. The carbon monoxide sensor 348 may be located inside the mouth of the frame 336 of the housing and may extend beyond the edge of the mouth of the frame 336 of the housing. The mouthpiece 342 may be seated on the rim of the mouth of the frame 336 of the housing so that the mouthpiece 342 can provide a seal between the mouth of the frame 336 of the housing with the carbon monoxide sensor 348 extending downward into the upper opening 343 of the mouthpiece 342.

[167] The main body portion 338 is an elongated hollow body, open at one end and having an oval cross-section. The main body portion 338 may have a curved front wall and a curved back wall. The front wall may have a cutout so that the lid 308 can be attached to the main body portion 338. The main body portion 338 may have an opening at one end that can contact the mouthpiece 342. A cutout may be made in the upper portion of the back wall of the main body portion 338 to form an opening 350 of an arbitrary shape. The opening 350 of an arbitrary shape may correspond to the lower portion of the flat back wall 307, which may be made of a transparent material. Through the opening 350 of an arbitrary shape, a portion of the vial 324 may be visible when the vial 324 is contained inside the main body portion 338. For example, this is necessary so that the QR code 323 is visible through the free-form opening 350. In this way, another device can scan the QR code, for example, to verify authenticity, when the vial 324 is located inside the main part 338 of the housing.

[168] The mouthpiece 342 may be attached to the frame 336 of the housing and may be in contact with the main part 338 of the housing. The mouthpiece 342 may include an upper opening 343 in the upper part of the mouthpiece 342, which may be attached to the frame 336 of the housing. The edge of the upper opening 343 may be in contact with the edge of the main part 338 of the housing. The upper opening 343 may correspond to the size of the carbon monoxide sensor 348 so that the carbon monoxide sensor 348 can protrude into the mouthpiece 342 through the upper opening 343.

[169] The mouthpiece 342 may comprise a circular opening 346 (see FIG. 4A). The circular opening 346 may be arranged to supply a flow of air from the user to insert the mouthpiece 342 through the circular opening 346. The mouthpiece 342 may include a recess on the surface of the mouthpiece 342 that helps the user to use the mouthpiece 342 correctly. For example, the recess may indicate to the user that the user can take the mouthpiece 342 into the mouth so that his upper lip is in contact with the recess. The mouthpiece 342 may include an oval opening 344. The oval opening 344 may be arranged to supply a flow of air from the user to remove the mouthpiece 342 through the oval opening 344.

[170] The carriage frame 329 may be attached to the housing frame 336. For example, the carriage frame 329 may be mounted to the housing frame 336 using one or more screws. The carriage frame 329 may include a pair of tabs depending on the ends of a connecting hook that may extend perpendicular to each of the tabs. A recessed or cut-out portion may be provided in the center of the hook of the carriage frame. The cut-out portion of the hook allows the carriage 328 to be positioned within the cut-out portion so that the carriage 328 can be positioned flush with the carriage frame 329 and can move relative to the carriage frame 329.

[171] The electronic device 600 may be attached to the carriage frame 329 using a screw, and the carriage frame 329 may be in a locking connection with the housing frame 336. The electronic device 600 may be connected to the port 332. The port 332 may be a universal serial bus (USB). The port 332 may be configured to receive power. The port 332 may be configured to send and/or receive data. The port 332 may be configured to receive a corresponding plug portion, such as the plug portion 334.

[172] The electronic device 600 may be connected and/or coupled to the battery 326. The battery 326 may include a battery, such as a lithium-ion battery. The electronic device 600 may include communication interfaces 124, sensors 126, electrical and electromechanical actuators 128, and a power management subsystem 130. For example, the electronic device 600 may include a sensor that can be used to read data from the QR code 323 and/or the microchip 325. The electronic device 600 may use the data to verify the authenticity of the vial 324.

[173] The electronic device 600 may comprise a printed circuit board with microcircuits mounted thereon. The printed circuit board may include serrated edges, such as serrated edge 602 (see FIG. 6A B), to facilitate its installation on the rear surface of the carriage frame 329. The electronic device 600 may be connected to the battery 326. The battery 600 may be attached to a surface of the printed circuit board of the electronic device 600 that may face away from the carriage frame 329. The electronic device 600 may be located between the battery 326.

[174] Various subcomponents of the dispenser 337 may be used to assemble the dispensing device 100, as described herein. The dispenser 337 may be slidably engaged with the housing 341 by moving the housing 341 by sliding onto the vial 324 and inserting the dispenser 337 into the locking connection. The lid 308 may be attached to the housing 341 by inserting into the locking connection.

[175] FIGS. 4A-D are perspective views of a smart NRT device in which the dispenser head is in a non-operating position (e.g., in a locked position). FIG. 4A is a front view of a smart NRT device, such as device 100. As shown in FIG. 4A, dispensing device 100 may include a cover 308, a main body portion 338, and a mouthpiece 342. Mouthpiece 342 may contain an oval opening 344 and a round opening 346. Cover 308 may contain square openings 310a, 310b, 310c, and 310d. Cover 308 may contain a central groove 311.

[176] The device 100 may be configured to not be in use to prevent accidental dispensing of the nicotine composition contained within the device 100. As shown in FIG. 4A, the dispenser head may be retracted into the housing such that the dispenser head may be located behind the cover 308, and the edge of the dispenser head may be flush with or below the edge of the cover 308. For example, as shown in FIG. 4B, in the inactive or locked position, the top portion 304 of the dispenser head may be flush with or below the edge of the cover 308. As shown in FIG. 4B, the face portion 306 of the dispenser head is lowered into the main portion 338 of the housing such that the lower section of the flat rear wall 307 and/or the QR code 323 may not be visible.

[177] FIG. 4G is a perspective cross-sectional view of the device 100 in an unused or inoperative position. As shown in FIG. 4G, the dispenser 100 may be configured to be unused to prevent accidental dispensing of the nicotine composition. The dispenser 337 may be lowered into the main body portion 338 to protect the dispenser 337 from mechanical impact, which may otherwise cause damage to the vial 324 and subsequent leakage of the substance. The dispenser 337 may be lowered to provide child resistance. For example, lowering the dispenser 337 into the main body portion 338 may prevent a child from dispensing from the device 100.

[178] As shown in FIG. 4D, the dispenser 337 can be lowered into the main body portion 338, leaving space for the carbon monoxide sensor 348. For example, the dispenser 337 can be lowered into the main body portion 338 so that the dispenser 337 cannot be damaged or brought into contact with the carbon monoxide sensor 348, providing protection from mechanical impacts that could otherwise damage the vial 324.

[179] FIGS. 5A-D are perspective views of a smart NRT device in which the dispenser head is in an operating position (e.g., in an unlocked position). FIG. 5A is a front view of a smart NRT device, such as device 100. As shown in FIG. 5A, dispensing device 100 may include a cover 308, a main body portion 338, a mouthpiece 342, and a dispenser head. The dispenser head may include a discharge nozzle 303, a face portion 306, and a top portion 304. The mouthpiece 342 may include an oval opening 344 and a round opening 346. The cover 308 may include square openings 310a, 310b, 310c, and 310d. The cover 308 may include a central groove 311.

[180] The device 100 may be configured to dispense a nicotine composition contained within the device 100. As shown in FIG. 5A, in the operating position, the outlet nozzle 303 may be free of obstructions so that the nicotine composition may be dispensed. The operating position of the device 100 allows the dispenser head to extend beyond the housing and cover 308. For example, as shown in FIG. 5B, the dispenser head may extend beyond the edge of the cover 308 and/or the edge of the main portion 338 of the housing.

[181] FIG. 5B shows a front portion 306 of the dispenser head that is raised above the main portion 338 of the housing so that the lower portion of the flat back wall 307 of the front portion 306 can be visible. The flat back wall 307 can be made of a transparent material so that a portion of the flat back wall 307 can function as a window through which the QR code 323 is accessible. The QR code 323 can be applied to the vial 324.

[182] As shown in FIG. 5D, the dispenser 337 may be raised within the main body portion 338 so that the locking mechanism 1004 can move. As further described herein, having a certain space allows the locking mechanism 1004 to move between a first position (e.g., an operating position), in which movement of the driving element to operate the dispenser is possible, and a second position (e.g., an inoperative position), in which movement of the driving element may not be possible.

[183] FIGS. 6A-B are schematic views of an example of one or more components in a smart NRT device that can be used to dispense a nicotine formulation. As described herein, a dispenser may include a number of subcomponents: a dispenser body in the form of a vial 324, a dispensing mechanism, a sleeve 320, a locking lever 322, and a drive element. The dispensing mechanism may be in the form of a pump mechanism. The sleeve 320 may be configured to attach the pump mechanism 400 to the vial 324. The drive element may be a dispenser head 339, which may include a top 304. The locking lever 322 may engage the sleeve 320 such that the locking lever 322 is attached to the sleeve 320.

[184] FIG. 6A shows an example of a schematic view of a smart NRT device with a vial inserted into the housing. When the vial 324 is inserted into the housing, the vial 324, the locking lever 322, the sleeve 320, or the upper portion 304 of the dispenser head 339 may be in contact with the carriage 328. Insertion of the vial 324 may cause another component within the device 100 to move to contact the carriage 328.

[185] For example, the vial 324 may be connected to the upper portion 304 of the dispenser head 339 via the locking lever 322 and/or the coupling 320. The upper portion 304 of the dispenser head 339 is in contact with the carriage 328. When the vial 324 is inserted into the housing, the upper portion 304 may be pressed against the carriage 328, and the locking elements of the locking lever 322 may engage with the square hole 310b and the square hole 310d. The locking elements of the locking lever 322 may engage with the square hole 310b and the square hole 310d, allowing the device 100 to be locked in an inoperative position, in which the dispenser head 339 may be positioned flush with or below the edge of the main portion 338 of the housing. The carriage 328 may be connected to one or more biasing members, such as a spring, so that the carriage 328 may be pressed against the upper portion 304.

[186] Contact with the carriage 328 may cause the carriage 328 to move, and the sensor may sense such movement. After detecting that the carriage 328 has moved, the sensor may send a signal indicating that the vial 324 has been inserted. In this way, the device 100 may determine when the vial 324 has been inserted into the housing. The device 100 may use a sensor to detect a QR code or a microchip associated with the vial 324. The device 100 may use a wire contact to connect to a wire track or a microchip associated with the vial 324. The device 100 may use the QR code, the microchip, and/or the wire track to determine the amount of nicotine composition that can be dispensed from the vial 324, the volume of the nicotine composition inside the vial 324, the concentration of the nicotine composition inside the vial 324, the expiration date of the nicotine composition inside the vial 324, and/or the like.

[187] The vial 324, the locking lever 322, or the coupling 320 may remain in contact with the carriage 328 or may remain in contact with a component that is in contact with the carriage 328. For example, the vial 324 may be connected to the top 304 via the locking lever 322 and the coupling 320.

[188] When the dispenser is activated, the actuation motion may cause the carriage 328 to move. For example, the actuation motion may apply downward pressure to the carriage 328 and may cause the carriage 328 to move downward toward the distal end of the housing, where a mouthpiece may be located. Such movement may be detected by a sensor. The device 100 may use the sensor to detect movement that may indicate the dispensing of a portion of the nicotine composition. When determining the potential dispensing of a portion of the nicotine composition, the device 100 may also determine whether the movement of the carriage 328 has exceeded a threshold value. This threshold value may be selected to prevent false positives. For example, this threshold value may be selected to ensure that small movements of the carriage 328, such as those that may occur when the device 100 is shaken or dropped, are not detected as indicative of the dispensing of the nicotine composition.

[189] The carriage 328 may be made of a magnetic material or may comprise a magnetic component. For example, the carriage 328 may comprise an opening, and a magnetic component, such as a small magnet, may be inserted into the opening (e.g., by a press fit). The starting motion may cause the carriage 328 to move toward the carbon monoxide sensor such that the carriage 328 or the magnetic component of the carriage may pass over the sensor, which may sense the presence of a magnetic field generated by the magnetic material. For example, the sensor may be a Hall effect sensor, and the movement of the carriage 328 may be determined by measuring the magnitude of the magnetic field generated by the magnetic material or the magnetic component of the carriage 328.

[190] The movement and direction of movement of the carriage 328 may be determined using one or more sensors. For example, the carriage 328 may pass over one or more Hall effect sensors, and the detection sequence may indicate the direction of movement of the carriage 328.

[191] The carriage 328 may be used in conjunction with a sensor to determine when a portion of the nicotine composition has been dispensed. For example, the device 100 may use a sensor to determine when the carriage 328 has moved, which is indicative of the dispensing of a portion of the nicotine composition. The device 100 may record the time of dispensing the portion, the location of dispensing the portion, and/or the number of portions dispensed. For example, the device 100 may record the number of portions remaining in the vial 324.

[192] In examples, device 100 may determine that movement of carriage 328 indicates that vial 324 has been inserted. Device 100 may determine a series of sequential movements of carriage 328 that may indicate that the pump mechanism has been filled with liquid. Device 100 may determine that movements of carriage 328 associated with filling should be ignored and may not consider them as dispensing of nicotine composition.

[193] The movement of the carriage 328 may be limited by the carriage frame 329, for example, to prevent the carriage 328 from coming into contact with the carbon monoxide sensor 348. For example, this is necessary to protect the carbon monoxide sensor 348 from damage as a result of a collision with the carriage 328.

[194] FIG. 6B shows an example of a schematic view of a smart NRT device with a vial removed from the housing. When the vial 324 is removed from the housing of the vial 324, the locking lever 322, the sleeve 320, or the upper portion 304 of the dispenser head 339 may remain in contact with the carriage 328 until the vial 324 is removed. Removal of the vial 324 may cause another component to move within the device 100 while maintaining contact with the carriage 328.

[195] For example, the vial 324 may be connected to the upper portion 304 of the dispenser head 339 via the locking lever 322 and/or the coupling 320. The upper portion 304 of the dispenser head 339 is in contact with the carriage 328. After the vial 324 is removed from the housing, the locking elements of the locking lever 322 may engage with the square hole 310b and the square hole 310d. The locking elements of the locking lever 322 may be disconnected from the square hole 310b and the square hole 310d so that the carriage 328 can push the dispenser head beyond the edge of the main portion 338 of the housing to remove the vial 324.

[196] The device 100 may determine that the movement of the carriage 328 indicates the removal of the vial 324. The device 100 may determine the removal of the vial 324 by the movement of the carriage exceeding a threshold. For example, the device 100 may determine that the carriage has moved over one or more Hall effect sensors in a sequence that indicates the removal of the vial.

[197] FIG. 7 is a schematic view of components in a smart NRT device that can be used to dispense nicotine and/or detect the fact of nicotine dispensing. As shown in FIG. 7, the carriage frame 329 may comprise a pair of tabs depending on the ends of a connecting hook that may extend perpendicular to each of the tabs. The pair of tabs belonging to the carriage frame 329 may end at a distance above the carbon monoxide sensor 348 to prevent the carriage 328 from coming into contact with the carbon monoxide sensor 348.

[198] A recessed or cut-out portion may be provided in the center of the carriage frame 329 hook. Due to the cut-out portion of the hook, the carriage 328 may be positioned within the cut-out portion of the carriage frame 329 hook so that the carriage 328 may be positioned flush with the carriage frame 329 and at the same time may move relative to the carriage frame 329. The carriage 328 may have an end that may extend beyond the carriage frame 329 and may end with a protruding leg. For example, the protruding leg may be positioned at the distal end of the carriage 328. The protruding leg of the carriage 328 may be in contact with the vial 324, the locking lever 322, the coupling 320 and/or the upper portion 304 of the dispenser head. For example, the protruding leg of the carriage 328 may be in contact with the top portion 304 such that the carriage 328 can move when a vial is inserted, when the smart NRT device is activated to dispense nicotine, and/or when a vial is removed.

[199] The carriage frame 329 may be attached to the electronic device 600, for example, using one or more screws. The electronic device 600 may comprise a printed circuit board with microcircuits mounted thereon. The printed circuit board may include serrated edges, such as serrated edge 602, to facilitate its installation on the rear surface of the carriage frame 329. The electronic device 600 may be connected to the battery 326. The battery 600 may be attached to the surface of the printed circuit board of the electronic device 600 facing away from the carriage frame 329. The electronic device 600 may be located between the battery 326.

[200] FIGS. 8A-B are schematic views of a carriage system in a smart NRT device that may be used to detect and/or record the insertion of a vial, the removal of a vial, and/or the dispensing of nicotine.

[201] As shown in FIG. 8A, the carriage 328 may be located in a cut-out portion of the hook of the carriage frame 329. One end of the carriage 328 may be terminated by a protruding leg, and the opposite end of the carriage 328 may be terminated by a T-shape. The carriage 328 may have a long rectangular shape, with its long side extending parallel to the carriage frame 329. The T-shape of the carriage 328 may be the width of the opening formed by two tabs of the carriage frame 329. Above the T-shape, an opening may be located passing through the carriage 328 to receive a pin passing through the carriage 328. The pin may be perpendicular to the long side of the carriage 328. The pin may be attached to the spring 330 and the spring 331.

[202] The carriage 328 may be made of a magnetic material or may comprise a magnetic component. For example, the carriage 328 may comprise an opening and a magnetic component 808, which may be a small magnet that can be inserted into the opening (e.g., by a press fit).

[203] The spring 330 and the spring 331 may be biasing members and may control the movement of the carriage 328. For example, the spring 330 and the spring 331 may bias toward the engagement of the carriage frame 329, which will thus result in pushing the T-shape of the carriage 328 toward the engagement of the carriage frame 329. The carriage 328 may come into contact with the upper portion 304 (not shown) of the dispenser head. The carriage 328 may push the upper portion 304 upward so that the dispenser (e.g., the dispenser 337 shown in FIGS. 3A-B) can be moved into an operating position (e.g., FIGS. 5A-B) or into a position in which insertion or removal of a vial is possible (e.g., FIG. 6B). The carriage 328 may push the top portion 304 upward in such a way as to provide resistance when pushing the dispenser into the locked position and/or the inoperative position (e.g., FIGS. 5B-5D).

[204] FIG. 8A shows the carriage system in a position that can be used to detect and/or register the insertion of a vial or the dispensing of nicotine. The spring 330 and the spring 331 can provide resistance that indicates to the user that the vial 324 is properly inserted. For example, the spring 300 and the spring 311 can be biasing elements that cause the carriage 328 to contact the top 304 and press the top 304 upward so that the dispenser comes out of the housing. The spring 300 and the spring 331 can provide resistance so that when the vial 324 is inserted, the carriage 328 can move a distance to maintain contact with the top 304. This distance can be detected by a sensor and can be an indication of the insertion of the vial 324.

[205] The spring 330 and the spring 331 may provide resistance such that when the device 100 is activated to dispense the nicotine composition, the resistance from the spring 330 and the spring 331 may control the movement of the carriage 328 so as to move the carriage 328 a certain distance. This distance may be determined by the sensor and may be indicative of the dispensing of the nicotine composition.

[206] The carriage frame 329 may be attached to the housing frame 336. The housing frame 336 may be attached to the main part 338 of the housing, for example, using a screw. The housing frame 336 may have a hollow cylindrical neck portion that provides an open mouth at one end. The carbon monoxide sensor 348 may be located inside the mouth of the housing frame 336 and may extend beyond the edge of the mouth of the housing frame 336. The mouthpiece 342 may be seated on the rim of the mouth of the housing frame 336 so that the mouthpiece 342 can provide a seal between the mouth of the housing frame 336 and the carbon monoxide sensor 348 extending downward into the upper opening 343 of the mouthpiece 342.

[207] FIG. 8B shows a carriage system in a position that can be used to determine and/or record the removal of a vial after dispensing nicotine. Spring 330 and spring 331 are connected to carriage 328 so as to push carriage 328 upward toward upper portion 304. Spring 330 and spring 331 can apply pressure on upper portion 304 via carriage 328 so that the dispenser can be pushed out of the housing to remove vial 324. Spring 330 and spring 331 can apply pressure on upper portion 304 via carriage 328 so that the dispenser can be moved within the housing to place the device in an operating position.

[208] The spring 300 and the spring 331 may provide resistance such that when the vial 324 is removed, the carriage 328 may move a certain distance. This distance may be determined by a sensor and may be an indication of the removal of the vial 324.

[209] The spring 330 and the spring 331 may provide resistance such that when the device 100 is actuated to dispense the nicotine composition, the resistance from the spring 330 and the spring 331 may control the movement of the carriage 328 so as to move the carriage 328 a certain distance. This distance may be determined by the sensor and may be indicative of the dispensing of the nicotine composition.

[210] The carriage 328 may be made of a magnetic material or may include a magnetic component. For example, the carriage 328 may include an opening and a magnetic component 808, which may be a small magnet that can be inserted into this opening (for example, by a press fit). As the carriage 328 moves, it can pass over the sensor 802, the sensor 804 and the sensor 806. The sensor 806 can be placed behind the carriage 328, as shown in FIGS. 8A and 8B. The sensor 806 can be positioned such that the sensor 806 can be in close proximity to the magnetic component 808 when the T-shape of the carriage 328 is pushed toward the hook of the carriage frame 329.

[211] The movement of the carriage 328 may be determined using the sensor 802, the sensor 804, and the sensor 806. For example, the sensor 802, the sensor 804, and the sensor 806 may be a Hall effect sensor, and the movement of the carriage 328 may be determined by measuring the magnitude of a magnetic field generated by the magnetic material of the carriage 328 and/or the magnetic component 808.

[212] The starting motion may cause the carriage 328 to move toward the carbon monoxide sensor 348 such that the carriage 328 or the magnetic component 808 may pass over the sensor 802, the sensor 804, and the sensor 806.

[213] The movement and direction of movement of the carriage 328 may be determined using one or more sensors. For example, the carriage 328 may pass over one or more Hall effect sensors, and a detection sequence may indicate the direction of movement of the carriage 328. The fact that a vial has been inserted may be determined by the magnetic component 808 passing over or in close proximity to the sensor 806. The fact that a vial has been removed may be determined by the magnetic component 808 passing over the sensor 804, passing over the sensor 802, and passing over or in close proximity to the sensor 806. The fact that a dose of nicotine has been dispensed may be determined by the fact that the magnetic component 808 passes over the sensor 802 and passes over or in close proximity to the sensor 804.

[214] The magnetic component 808 and/or the carriage 328 may be used in combination with the sensor 802, the sensor 804, and the sensor 806 to determine that the movement of the carriage 328 and/or the magnetic component 808 indicates the insertion of the vial 324. The sensor 802, the sensor 804, and the sensor 806 may determine a series of subsequent movements of the carriage 328 and/or the magnetic component 808, which may indicate the filling of the pump mechanism with liquid. The device 100 may determine that the movements associated with filling should be ignored and may not consider them as the dispensing of the nicotine composition.

[215] The magnetic component 808 may be moved to a position that may be above the sensor 804, or may be in this position (e.g., FIG. 8A). For example, this may occur when the nozzle 303 may be in a retracted position within the main body portion 338, and the dispenser head 339 may be positioned flush with the top edge of the main body portion 338 or below.

[216] The magnetic component 808 may be moved to a position that may be above the sensor 806, or may be in this position (e.g., FIG. 8B). For example, this may occur when the dispenser head 339 may be in the extended position and the nozzle 303 may be outside the main body portion 338. As shown in FIG. 8B, the sensor 806 is not visible because it is covered by the carriage 328, which includes the magnet 808.

[217] The magnetic component 808 and/or the carriage 328 may be used in combination with the sensor 802, the sensor 804, and the sensor 806 to determine whether a portion of the nicotine composition has been dispensed. For example, the sensor 802, the sensor 804, and the sensor 806 may determine movement of the carriage 328 and/or the magnetic component 808 that indicates the dispensing of a portion of the nicotine composition.

[218] The smart NRT device may detect the dispensing of nicotine when the magnetic component 808 moves from a position that may be in close proximity to or overlapped by the sensor 806 to a position that may be in close proximity to or overlapped by the sensor 802. At the user's discretion, the actuator may move or return to the extended position, which may cause the magnetic component 808 to return to a position that may be in close proximity to or overlapped by the sensor 806. The user may press the actuator down to lock it within the housing, which may cause the magnetic component 808 to move to a position that may be in close proximity to or overlapped by the sensor 804.

[219] FIG. 9 is a schematic view of a smart NRT device that may include a sensor, such as a carbon monoxide sensor, to detect tobacco consumption by a user. As shown in FIG. 9, a mouthpiece 342 may be located at the end of the body of the device 100. For example, the mouthpiece 342 may be the opposite end of the dispenser head. The mouthpiece 342 may be configured to direct the flow of exhaled air by the user through the mouthpiece and past the carbon monoxide sensor. For example, the user may exhale air into the circular opening 346 so that the exhaled air by the user passes over the carbon monoxide sensor 348 and exits into the mouthpiece 342 through the oval opening 344. The carbon monoxide sensor 348 may use the exhaled air by the user to determine the level of carbon monoxide in the user's body. For example, carbon monoxide sensor 348 may detect the level of carbon monoxide from the air flow through mouthpiece 342. Device 100 may use the carbon monoxide level to determine the amount of carbon monoxide in the user's body. Device 100 may determine that the amount of carbon monoxide indicates that the user may have consumed one or more tobacco products.

[220] FIG. 10 is a schematic view of a locking mechanism in a smart NRT device that can be used to prevent the dispensing of a nicotine formulation. Device 100 may include an electromagnet 1002 that may be operatively connected to locking mechanism 104. As shown in FIG. 10A, device 100 may be in an operating position, as shown by element 1010, the dispenser head may extend above the main body portion. In this way, the dispenser may move within the main body portion so that a space is provided for vial 324 that allows locking mechanism 1004 to move between a first position (e.g., an operating position), in which the driving element can move to actuate the dispenser, and a second position (e.g., an inoperative position), in which movement of the driving element may be impossible.

[221] The locking mechanism 1004 can be used to prevent the movement of the dispenser head. For example, as shown in FIG. 10A, the locking mechanism 1004 can contact the carriage 328. The locking mechanism 1004 can block the downward movement of the carriage 328, which can prevent the implementation of the spraying operation and can prevent the movement of the device 100 to the inoperative position. The locking mechanism 1004 can be placed in the operative position using the solenoid 1002. For example, the device 100 can determine that the vial 324 has not been authenticated and can send a signal to the solenoid 1002 that causes the solenoid to move the locking mechanism 1004 to the blocking or inoperative position in order to prevent the movement of the drive element.

[222] The device 100 may determine that the vial 324 has been authenticated and may send a signal to the electromagnet 1002 that causes the electromagnet 1002 to move the locking mechanism 1004 to an operating position. For example, as shown in FIG. 10B, the locking mechanism 1004 has been moved to position 1008, resulting in a space 1006 that allows the carriage 328 to move downward.

[223] The locking mechanism 1004 may be used to prevent the user from receiving an amount of nicotine that exceeds a certain value. For example, the user may be allowed to receive an amount of nicotine that he can consume over a period of time, such as during a day. If the user attempts to exceed the amount of nicotine that he can consume, the electromagnet 1002 may receive a signal to move the locking mechanism 1004 to an inoperative position such that the locking mechanism 1004 can contact the carriage 328, and the user is unable to dispense nicotine using the device 100.

[224] The locking mechanism 1004 can be used to ensure the delivery of nicotine to the user. For example, it can be assumed that the user may have an urge to smoke. And the user can be notified of the delivery of a portion of nicotine using the device 100. The electromagnet 1002 can receive a signal to move the locking mechanism 1004 to the operating position such that the locking mechanism cannot contact the carriage 328, and the user has the opportunity to deliver nicotine using the device 100.

[225] To allow the device 100 to move to the inoperative position, as shown in FIG. 10B, the electromagnet 1002 may cause the locking mechanism 1004 to move to the operative position to avoid contact with the carriage 328. The carriage 328 may move downward along with the dispenser. For example, the dispenser may move into the housing such that the device 100 may become more compact and may be in the inoperative position. Although the electromagnet 1002 may be shown in this case, the electromagnet 1002 may be replaced with another compatible component, such as a piezoelectric motor.

[226] The user may interact with an NRT application and/or a behavioral support application, such as one installed on a smartphone, tablet, and/or smartwatch. As described with reference to FIG. 2B, the application may receive data from an NRT smart device (e.g., a portable nicotine dispensing device), a smartwatch, and/or a remote server. Such an application may analyze the received data and provide a personalized program to the user.

[227] The personalized smoking/nicotine cessation program may include a standard 12-week procedure with biometric feedback and behavioral models. Such procedure may be dynamic and personalized for a specific user of the system during the program implementation. For example, the duration of the program may be determined based on the user's smoking behavior before using the NRT device. For example, if the user is not a heavy smoker, the program duration may be less than 12 weeks. For a heavy smoker with a long history of smoking, a longer program (e.g., lasting more than 12 weeks) may be provided. The duration of the smoking cessation program may be updated based on various collected data, as described herein. The smoking cessation program may also be adapted to users of other tobacco products, e-cigarettes, and e-smoking products. For example, a smoking cessation program can be adapted to a user who may consume nicotine from cigarettes, tobacco products, nicotine e-cigarettes, and/or nicotine from an alternative source such as a patch, gum, nasal spray, inhaler, lozenge/tablet, oral spray, etc.

[228] The application may receive biometric data, which may be referred to as biomarker data, associated with a user, such as from a smartwatch, smartphone, smart NRT device, and/or other devices. For example, biological sensors or a smartwatch may provide biometric data such as heart rate, heart rate variability, skin temperature, user gestures, and/or the like. The biometric data may be used to predict the onset of a smoking urge or a potential relapse to smoking or nicotine consumption. Recommendations for coping strategies may be provided by the application based on the predicted smoking urge or a potential relapse to smoking or nicotine consumption.

[229] As described herein, the smart NRT device may include an accelerometer. The user's movement or gestures may be determined based on signals from the accelerometer. For example, information about the user's gestures may be used to determine the user's restlessness. This information may be used to predict smoking urges and preventatively relieve such urges by activating the use of NRT or performing a series of self-control exercises (e.g., breathing exercises).

[230] The application may receive CO level information, for example from a smart NRT device. Based on biometric feedback and/or information on CO level improvement, it may be possible to determine health improvements associated with a reduction in the number of cigarettes smoked/nicotine consumed.

[231] FIG. 11A shows an example of a user interface for entering cigarette consumption data. FIG. 11B shows an example of a user interface for collecting other information related to the passage of NRT. The application allows a user to enter information about smoking a cigarette and/or tobacco and/or an electronic cigarette and/or electronic smoking products and/or about the consumption of another NRT substance, such as the date and time of each smoking, the location and/or the associated trigger. At step 1102, the user may enter the time and/or date when the smoking event occurred and/or the NRT event occurred. The event may have occurred in the past, may be occurring currently, or may occur in the future. For example, the user may plan to smoke and/or consume nicotine after entering the specified information. At step 1104, the user may enter the location for the smoking event and/or the NRT event. The location for the event may be manually entered by the user, or the user may determine the location using a smartphone (e.g., using a GPS system associated with the smartphone). At step 1106, the user can enter a trigger that may induce a smoking event and/or a NRT event. For example, the user may indicate that increased stress was the trigger. At step 1108, the user may enter the type of nicotine formulation used. For example, the user may indicate that they used nicotine gum, a nicotine spray, and/or the like.

[232] Recommendations for reducing cigarette/tobacco/e-cigarette/e-smoking product/NRT consumption may be determined based on data including, but not limited to, user-specified triggers, system-set triggers, user biometric data, cigarette/tobacco/e-cigarette/e-smoking product/NRT consumption tracking data, user age, gender, geographic location, and/or daily activities. For example, recommendations may be identified in such a way that the user can start with simpler actions, i.e., reducing cigarette consumption or replacing cigarette consumption with NRT, and this may increase the likelihood of successfully reducing tobacco consumption and ultimately quitting smoking.

[233] Information on NRT/nicotine formulation consumption may be obtained, for example, from a nicotine formulation dispensing device. The consumption information may include the amount of nicotine formulation dispensed and the time associated with consumption. Information on NRT/nicotine formulation consumption may be tracked over time.

[234] Information regarding the user's carbon monoxide level may be obtained, for example, from a nicotine dispensing device. The obtained carbon monoxide level in the user's body may be time-stamped and tracked over time.

[235] One or more triggers may be obtained for an NRT smoking or consumption event. Triggers may be obtained based on various data collected from various sources. For example, the application may receive data from other sources on the smartphone, such as a calendar, to identify actions that may constitute a trigger. For example, location-based triggers may be obtained by correlating NRT dispensing data with the user's location. Triggers may be continuously retrieved, updated, and/or deleted based on the collected data.

[236] FIG. 12 shows an example of user interfaces for displaying the progress of a nicotine replacement therapy program. The health improvement information may include, but is not limited to, a decrease in CO levels and/or a decrease in heart rate. At step 1202, a goal may be presented to the user. The goal may indicate that the user needs to reduce cigarette consumption by a certain amount. For example, at step 1202, the goal may indicate that the user needs to replace 50% of the cigarettes that he or she might smoke with a nicotine formulation. The goal may also indicate a phase in the smoking cessation program that the user may be in, lasting one week. At step 1204, the progress of the program may be displayed. The progress of the program may indicate the amount of nicotine that the user can consume. For example, the progress of the program may indicate how much nicotine the user can consume and how much nicotine the user has already consumed. This can be used, for example, to indicate to the user how much nicotine he or she can consume. At step 1206, the interface may include an indication of the number of cigarettes smoked by the user, and/or the amount of tobacco consumed by the user, and/or the amount of electronic cigarettes or electronic smoking products consumed by the user, and/or the amount of nicotine formulation consumed by the user. The interface may include an indication of the number of days during which the user has gone without consuming nicotine from cigarettes, tobacco products, electronic cigarettes with nicotine, and/or nicotine from an alternative source, such as a body patch, chewing gum, nasal spray, inhaler, lozenges/tablets, oral spray, etc.

[237] At step 1208, the interface may indicate which week of the program the user may be in. For example, the interface may indicate that the user is in week 4 of a 12-week program. At step 1210, the interface may indicate the amount of money saved by quitting smoking. Providing information about improvements at a point in time (e.g., at key points) during the procedure may increase the likelihood that the user will not quit the program. At step 1212, the user interface may indicate that the application is connected to a smart NRT device, such as via Bluetooth. At step 1220, the battery life of the smart NRT device may be indicated. At step 1222, the amount of nicotine formulation in a vial associated with the smart NRT device may be indicated.

[238] FIG. 13 illustrates an example of user interface(s) for specifying personalized weekly goals and plans. As shown in FIG. 13, the application may provide personalized weekly goals and/or specifically timed daily/weekly lifestyle change activities that the user is required to follow during this stage of the process.

[239] At step 1302, the user interface may indicate that the user may be in week 1 of the smoking cessation program. A goal may be established associated with a particular week of the smoking cessation program. For example, the goal of week 1 of the smoking cessation program may be to replace 25% of the cigarettes that the user may have smoked with a nicotine formulation. A daily action may be established associated with a particular week of implementation of the smoking cessation program. For example, the action for day 1 of week 1 of the smoking cessation program may be to replace every second cigarette smoked daily.

[240] At step 1304, the user interface may indicate that the user may be in week 5 of the smoking cessation program. A goal may be established associated with a particular week of the smoking cessation program. For example, the goal of week 5 of the smoking cessation program may be to avoid smoking cigarettes and to focus on using a nicotine formulation. A daily action may be established associated with a particular week of implementation of the smoking cessation program. For example, the action on day 1 of week 5 of the smoking cessation program may be to bring the user's CO level into a range or below a threshold.

[241] At step 1306, the user interface may indicate that the user may be in week 10 of the smoking cessation program. A goal may be established associated with a particular week of the smoking cessation program. For example, the goal of week 10 of the smoking cessation program may be to reduce dependence on the nicotine formulation by 25%. A daily action may be established associated with a particular week of implementation of the smoking cessation program. For example, the action on day 1 of week 10 of the smoking cessation program may be to reduce the consumption of the nicotine formulation by one serving.

[242] FIG. 14 illustrates an example of user interface(s) for creating a personalized cigarette substitution plan. The plan for a week, such as week 1, may include identifying a number of cigarettes to be replaced with an NRT/nicotine formulation based on the user's perceived stress levels, heart rate values, triggers, and/or the like. For example, at step 1402, the application may identify that one or more cigarettes smoked by the user should be considered for replacing with a nicotine formulation based on the heart rate. The user may interact with the interface and may select one or more identified cigarettes. The user may be presented with a time and heart rate associated with the selected cigarette. In another example, at step 1402, the application may identify that one or more cigarettes smoked by the user should be considered for replacing with a nicotine formulation based on the heart rate and a trigger. The user may interact with the interface and may select one or more identified cigarettes. The user can be presented with the time, heart rate and trigger associated with the selected cigarette.

[243] At step 1406, the user may be presented with one or more cigarettes that the user may select to replace with a nicotine formulation. At step 1406, reminders or events may be added to the calendar to remind the user to use the NRT/nicotine formulation.

[244] FIG. 15A shows an example of a user interface that offers an action before the onset of a predicted urge to smoke. The onset time of the predicted urge to smoke may be determined based on various data. For example, the onset time of the predicted urge to smoke may be determined based on nicotine consumption information, CO level information in the user's body, location information, the user's heart rate, heart rate change, skin temperature, scheduled activity based on a calendar, and/or detection of user movement/gestures (e.g., restlessness). An action may be offered to be performed before the onset time of the predicted urge to smoke. For example, recommendations may be provided to use NRT or behavioral technique(s) aimed at overcoming such urge. As shown in step 1502, a warning message about the urge may be displayed. The use of a nicotine formulation in an NRT device can be suggested in advance, based on a predicted potential urge. An action can be suggested to distract the user from the predicted urge to smoke. For example, at step 1502, the user may be presented with the option of using NRT or implementing a behavioral strategy aimed at overcoming the urge.

[245] FIG. 15B shows an example of a user interface in which a user can select an action aimed at overcoming a predicted urge to smoke. For example, the user can select a behavioral strategy aimed at overcoming the urge. At step 1504, one or more suggested distractions can be selected for a particular week or a particular period of time. Suggested distractions can include deep breathing exercises, games (e.g., a video game or an app), taking a walk, spending time on social media, communicating with friends, and/or the like.

[246] FIG. 15C illustrates an example of a user interface that prompts the user to confirm cigarette consumption. For example, the user may decide not to use the suggested coping strategy. The application may analyze the user's heart rate and CO level. The application may determine that the user may have smoked a cigarette based on the user's CO level and/or the user's heart rate information. Upon determining that the user has consumed cigarettes, a message may be provided at step 1506 for the user to confirm the cigarette consumption. The confirmation may be used to track information about the user's cigarette consumption and/or information about the user's nicotine consumption.

[247] An application may send messages to a smart NRT device to control one or more components of the smart NRT device. For example, an application may send a message to the smart NRT device indicating that the device should stop dispensing a nicotine formulation, such as for a period of time or until a resumption message is received. The application may send a message to the smart NRT device indicating that a portion of the nicotine formulation may be dispensed. The application may send an indication of the amount of nicotine formulation that may be dispensed, such as during a period of time, during use, or until a resumption message is received. The resumption message may be sent after a period of time has elapsed, which may be determined based on various data collected and/or tracked as described herein.

[248] It may be determined whether to activate a lock on a nicotine formulation dispenser. For example, the determination may be based on a nicotine threshold (e.g., a standard threshold or a personalized threshold) for the user and the amount of nicotine previously consumed by the user. The lock may be activated if it is determined that the amount of nicotine consumed by the user (e.g., over a period of time) exceeds the nicotine threshold (e.g., associated with that period of time). The amount of nicotine previously consumed by the user may be determined based on monitored tobacco product or NRT consumption data and/or the user's carbon monoxide level. The lock may be activated if it is determined that a vial whose authenticity has not been verified has been inserted into the NRT device. Authentication may be performed, for example, by recognizing a QR code. Blocking may be activated if the device is determined to be associated with a region where the use of the substance is prohibited.

[249] The standard nicotine threshold may include the number of sprayed doses, for example 64 sprayed doses. The threshold may also be different, for example 60, 62, 66, 68 sprayed doses, etc. Sprayed doses transferred for filling purposes may not be counted or excluded from the number of sprayed doses.

[250] A personalized nicotine threshold for a particular user may be determined based on one or more considerations, including, but not limited to, the user's CO level, the user's biometric data, the user's previous smoking habits, a daily consumption limit associated with an NRT program, cigarette consumption tracking, NRT consumption tracking, the user's age and gender, geographic location, and/or daily activities.

[251] The amount of formulation that may be dispensed over a period of time (e.g., per use, once every 30 minutes, once every hour, once every 24 hours) may be determined based on a predetermined nicotine consumption limit, the stage of the NRT program, the concentration of the nicotine formulation, the target nicotine reduction rate, and/or the like.

[252] The smartwatch may provide a user interface for the user, such as displaying metrics related to the smoking cessation process, the frequency of NRT use over a period of time (e.g., per half hour, per hour, per 24 hours), the number of cigarettes smoked, and/or the like. These metrics may be displayed against the smoking cessation program targets.

[253] FIG. 16A shows an example of a nicotine/smoking cessation program overview. The personalized smoking/nicotine cessation program may include a standard procedure, which may be a 12-week procedure. The smoking cessation program may be personalized for the user, for example, using biometric feedback and/or behavioral models. Such a procedure may be dynamic and personalized for a specific user of the system during the implementation of the program. For example, the duration of the program may be determined based on the user's smoking behavior before using the NRT device. For example, if the user is not a heavy smoker, the duration of the program may be less than 12 weeks. For a heavy smoker with a long history of smoking, a longer program (e.g., lasting more than 12 weeks) may be provided. In another example, the duration of the program may be determined and/or adjusted by the user. At step 1602, the personalized smoking/nicotine cessation program may be presented to the user. A slider control may be presented to the user. The user can use a slider to lengthen or shorten the smoking cessation program. For example, the user may be presented with a duration range, and use the slider to select from a range of durations.

[254] FIG. 16B illustrates an example of a user interface for providing the user with feedback on CO level reduction information that is collected and tracked throughout the program. The application may track one or more CO levels for the user. For example, the application may store a series of CO levels for the user measured over a period of time. Based on the CO levels, the application may determine that the user has reduced his or her cigarette consumption. For example, at step 1602, the user may be notified that his or her series of CO levels shows that the CO levels have decreased from 21 ppm to 5 ppm. The user may also be notified that a value of 5 ppm indicates that the user's CO level is at the level of a non-smoker.

[255] FIG. 16B shows an example of a user interface for providing the user with feedback on the user's heart rate information that is collected and monitored throughout the program. The application may monitor one or more heart rate measurements for the user. For example, the application may store a series of heart rate measurements taken from the user over a period of time. Based on the heart rate measurements, the application may determine that the user's health has improved. For example, at step 1606, the user may be notified that his or her resting heart rate has decreased from 83 to 70 over a 12-week period.

[256] A user's smoking behavior or nicotine addiction may be determined based on real-time feedback from biological indicators and/or behavioral support elements. The feedback information may be used to tailor a smoking cessation plan for the user during a quit attempt. For example, biomarkers, which may include physiological and phycological biomarkers, may be used to suggest actions and/or behavioral modifications to achieve the desired effect.

[257] FIGS. 17A-B illustrate examples of user interface(s) that suggest actions to take to benefit from implementing a nicotine cessation procedure. The timing of the suggestion may be determined based on biological indicators. FIG. 17A illustrates an example of a user interface that may suggest an action to a user based on one or more biomarkers. For example, one or more biomarkers may be used to determine that a user may experience an urge to smoke around lunchtime. The one or more biomarkers may indicate a possible positive development in the user associated with the smoking cessation program. For example, one or more biomarkers may indicate that the user has reduced nicotine consumption (e.g., reduced cigarette consumption or NRT). At step 1702, the user interface may suggest that the user celebrate his/her progress with some food. For example, the user interface may ask the user about his/her favorite food and may suggest that the user schedule the consumption of that food on a calendar. In FIG. 17B shows an example of a user interface in which a behavior modification is associated with an action selected by the user. For example, at step 1704, the user may schedule a meal, and the user interface may prompt the user to consciously consume the meal. This may be done, for example, to prevent the urge to consume nicotine, which may occur during a meal. FIG. 17C shows an example of a user interface that may request feedback from the user regarding an action and/or behavior modification. For example, at step 1706, the user interface may ask the user how the planned consumption of the meal went. The user may respond. The user's response may indicate that the user is actively performing the action. The response may indicate that the user has made a change in his or her behavior. The response may indicate the likelihood that this action prevented the urge to consume nicotine and/or reduced the likelihood of the urge to consume nicotine.

[258] FIG. 18 shows an example of a flow chart for providing a personalized nicotine cessation procedure. As shown, at the beginning of the personalized nicotine cessation procedure, at step 1802, initial user data may be collected. At step 1806, a personalized cessation procedure may be generated, at least in part based on the collected user data. At step 1808, as the procedure progresses, additional data may be collected, such as nicotine consumption information and biometric data of the user. At step 1810, a trigger may be determined, and at step 1812, a targeted notification may be provided. For example, a potential urge may be determined, and a suggestion to use NRT may be provided. For example, potential cigarette smoking may be determined based on the collected CO level in the user's body, and confirmation of the fact of smoking may also be requested. At step 1818, the personalized procedure may be modified based on the collected current user data. For example, the duration of the procedure may be shortened or lengthened. Weekly and/or daily targets may be updated. The type of behavioral suggestions may be refined based on the user's response. At step 1820, the smoking cessation program may be completed. The user's initial data and the collected data referred to in FIG. 18 may include various data received or obtained from various data sources described herein.

[259] FIG. 19 shows an example of a block diagram for controlling a lockout mechanism. At step 1906, nicotine consumption can be monitored, for example, using the techniques described herein. The nicotine consumption data can be determined based on the nicotine concentration of the nicotine formulation in the NRT device, the number of full actuations, partial actuations of the dispenser and the associated actuation time and/or cigarette smoking/tobacco consumption data recorded by the user. At step 1908, nicotine consumption can be compared to a threshold value. At step 1910, the lockout mechanism can be activated if it is determined that consumption has exceeded the threshold value. The threshold value of nicotine consumption can be associated with a period of time, such as 2 mg over half an hour, 4 mg over an hour, 64 mg over 24 hours, or the like. The nicotine consumption value can be reset after a period of inactivity during which the NRT device has not dispensed a nicotine composition. For example, after the NRT device has been inactive for 4 hours, the amount of nicotine consumed can be reset to 0 for comparison with the 24-hour consumption threshold. The determination of whether nicotine consumption has exceeded the threshold can be performed in the NRT device and/or another device, such as a mobile phone, smartwatch, tablet, cloud computing function, or the like. For example, a signal can be sent to the NRT device to instruct the NRT device to activate a lockout mechanism. The lockout mechanism can be deactivated after a period of time has elapsed. For example, the lockout mechanism can be deactivated after half an hour, one hour, two hours, or the like. If consumption has not exceeded the threshold, the NRT device can dispense a nicotine composition at step 1920.

[260] FIG. 20 illustrates an example of an NRT system. As shown in the figure, the example NRT system may include a smartphone 2002, a smartwatch 2004, an NRT device 2006, and a cloud 2010. A user 2008 may interact with the NRT system.

[261] The NRT device 2006 may receive commands from the smartphone 2002 to lock the dispenser. The NRT device 2006 may send data such as CO measurements, NRT dispensing data, vial authentication information, and/or vial information to the smartphone 2002. As described herein, the NRT device 2006 may include an NRT dispenser and a biometric sensor, such as a CO sensor. The NRT device 2006 may include one of more functions, including delivering NRT to the user, performing biometric CO determination, performing motion detection, locking the dispenser, and transmitting data to another device(s), such as via BLE.

[262] As shown in FIG. 20, an application with a user interface may run on a smartphone 2002. Through the application, the smartphone 2002 may perform one or more functions, including tracking user data, such as location data, providing a user interface, aggregating data, and calculating based on the data. For example, through a user interface in the application, the smartphone 2002 may receive various instructions from a user, such as user 2008. The user instructions may include one or more responses related to behavioral intervention, tracking of cigarette, NRT, or other nicotine product consumption, trigger tracking information, user demographic data, user smoking history, and/or the like. The smartphone 2002 may receive data from and/or send data to a smartwatch 2004. For example, via smartphone 2002, the application may receive data from smartwatch 2004, including GSR values, heart rate values, HRV values, peripheral blood oxygen saturation levels (e.g., SPO2), blood pressure, skin temperature values, and/or motion data. Smartphone 2002 may send user notifications and application status to smartwatch 2004 for display on smartwatch 2004.

[263] Smartphone 2002 may provide notifications to the user, such as through a user interface in an application. User notifications may include, but are not limited to, an indication of a potential urge to smoke, an indication of a potential smoking event, a recommended NRT, a request for CO measurement, provision of behavioral intervention recommendations, and provision of program/health status improvements.

[264] As shown, cloud-based control functions may be employed. For example, smartphone 2002 may send biometric data and user-entered data to cloud 2010 (e.g., one or more cloud servers, which may represent computing resource 212). Cloud 2010 may perform data aggregation, such as aggregating data from a community of users, perform calculations based on the data, and store various data. Cloud 2010 may refine an algorithm based on the received, aggregated, and/or calculated data. Cloud 2010 may send user notifications and software commands to smartphone 2002.

[265] As shown, the NRT system may include a smartwatch 2004 that can send various data to a smartphone 2002. The smartwatch 2004 may be or may include a wrist-worn device for determining biometric data and/or providing a user interface. The smartwatch 2004 may collect and filter biometric data from the user. The smartwatch 2004 may perform biometric measurements, such as measurements of GSR values, HR values, HRV values, SP02 values, blood pressure, skin temperature, and/or motion data. The smartwatch 2004 may send data, such as biometric data and regimen information, to another device(s), such as a mobile phone and the NRT device 2006. The smartwatch may be configured to provide notifications, such as notification of the onset of a smoking urge, recommendations for the use of NRT, and/or the provision of improvements in the program/health status.

[266] FIG. 21 shows an example of a 12-week NRT procedure that can be adjusted based on data from various sources, such as sensor feedback. The success rate of addiction recovery can be increased through various feedback and personalization. In examples, the user's biometric data can be collected during a control period, such as a period of time before the program is performed (e.g., one week before the program is started). A personalized program can be generated based on the biometric data collected during the control period and/or other baseline data about the user's behavior. The recommended program can be updated through a continuous update cycle, whereby the program can respond in a timely manner to the user's needs, such as lagging behind or ahead of expected development.

[267] As shown in FIG. 21, the program may include cigarette reduction targets that may be modified based on user data. The program may include NRT recommendations, such as NRT recommendations (e.g., during an initial phase of the program) and NRT reduction targets (e.g., at a later phase of the program), that may be modified based on user data (such as sensor feedback). The program may include NRT recommendations 2120 that may be provided and/or modified on a weekly basis. The program may include cigarette smoking recommendations 2128 that may be provided and/or modified on a weekly basis.

[268] At step 2102, the smoking cessation program may include a recommendation for a period of time before the program begins. For example, this may be done so that the user can become familiar with the smoking cessation app and/or the NRT device. This period of time may be three weeks before the potential cessation of cigarette smoking. With the recommendation at step 2102, the user can become familiar with the program, and the user may be advised not to reduce the number of cigarettes and/or NRT smoked.

[269] At step 2104, the smoking cessation program may include a recommendation for week 1. In week 1, the recommendation may be to reduce the number of cigarettes smoked by 50% and the use of NRT by 25%. For example, in week 1, the user may be recommended to reduce the baseline cigarette consumption by 50% and increase the baseline nicotine formulation consumption by 25%. The baseline cigarette consumption and/or the baseline nicotine formulation consumption may be based on a previous time period, a current time period, and/or a combination of both.

[270] At step 2106, the smoking cessation program may include a recommendation for week 2. In week 2, a recommendation may be made to reduce the number of cigarettes smoked by 25% and the use of NRT by 50%. For example, in week 2, the user may be recommended to reduce the baseline cigarette consumption by 25% and increase the baseline nicotine formulation consumption by 50%. The baseline cigarette consumption and/or the baseline nicotine formulation consumption may be based on a previous time period, a current time period, and/or a combination of both.

[271] At step 2108, the smoking cessation program may include a recommendation for week 3. In week 3, the recommendation may be to reduce the number of cigarettes smoked by 75% and the use of NRT by 75%. For example, in week 2, the user may be recommended to reduce the baseline cigarette consumption by 75% and increase the baseline nicotine formulation consumption by 75%. The baseline cigarette consumption and/or the baseline nicotine formulation consumption may be based on a previous time period, a current time period, and/or a combination of both.

[272] At stage 2110, the smoking cessation program may include a recommendation for week 4. At week 4, the recommendation may be to reduce the number of cigarettes smoked by 100% (i.e., to quit smoking completely) and to maintain the use of NRT at 100%. For example, at week 4, the user may be recommended to reduce the baseline cigarette consumption by 100% and to increase the baseline nicotine formulation consumption by 100%. The baseline cigarette consumption and/or the baseline nicotine formulation consumption may be based on a previous time period, a current time period, and/or a combination of both.

[273] At stage 2112, the smoking cessation program may include a recommendation for week 5. At week 5, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to maintain the use of NRT at 100% (e.g., maintain the use of the nicotine formulation). For example, at week 5, the user may be recommended to avoid smoking and continue to use the nicotine formulation.

[274] At stage 2114, the smoking cessation program may include a recommendation for week 6. At week 6, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to maintain the use of NRT at 100% (e.g., maintain the use of the nicotine formulation). For example, at week 6, the user may be recommended to avoid smoking and continue to use the nicotine formulation.

[275] At stage 2116, the smoking cessation program may include a recommendation for week 7. At week 7, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to maintain the use of NRT at 100% (e.g., maintain the use of the nicotine formulation). For example, at week 7, the user may be recommended to avoid smoking and continue to use the nicotine formulation.

[276] At stage 2118, the smoking cessation program may include a recommendation for week 8. For example, at week 8, the recommendation may be to leave the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and leave the use of NRT at 100% (e.g., maintain use of the nicotine formulation). For example, at week 8, the user may be advised to avoid smoking and continue using the nicotine formulation.

[277] At stage 2120, the smoking cessation program may include a recommendation for week 9. At week 9, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to reduce the use of NRT by 25% (e.g., reduce the use of nicotine formulation). For example, at week 9, the user may be recommended to avoid smoking and to reduce the baseline consumption of nicotine formulation by 25%. The baseline consumption of nicotine formulation may be based on a previous time period, a current time period, and/or a combination of both.

[278] At step 2122, the smoking cessation program may include a recommendation for week 10. At week 10, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to reduce the use of NRT by 50% (e.g., reduce the use of nicotine formulation). For example, at week 10, the user may be recommended to avoid smoking and to reduce the baseline consumption of nicotine formulation by 50%. The baseline consumption of nicotine formulation may be based on a previous time period, a current time period, and/or a combination of both.

[279] At stage 2124, the smoking cessation program may include a recommendation for week 11. At week 11, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to reduce the use of NRT by 75% (e.g., reduce the use of nicotine formulation). For example, at week 11, the user may be recommended to avoid smoking and to reduce the baseline consumption of nicotine formulation by 75%. The baseline consumption of nicotine formulation may be based on a previous time period, a current time period, and/or a combination of both.

[280] At stage 2126, the smoking cessation program may include a recommendation for week 12. At week 12, the recommendation may be to maintain the number of cigarettes smoked at 0% (e.g., the user may no longer smoke) and to reduce the use of NRT by 100% (e.g., the user may no longer consume a nicotine formulation). For example, at week 12, the user may be recommended to avoid smoking and to avoid consuming a nicotine formulation.

[281] The 12-week NRT procedure can also be adapted for smokeless tobacco users, heated tobacco product users, non-combustible tobacco product users, e-cigarette users, and/or e-smoking product users. For example, the 12-week NRT procedure can be adapted to nicotine consumption, which may include nicotine from a cigarette, a tobacco product, a nicotine e-cigarette, and/or nicotine from an alternative source such as a patch, gum, nasal spray, inhaler, lozenge/tablet, oral spray, etc.

[282] Before a user enters a typical smoking cessation program and periodically during the program, various data may be collected. Monitoring data may be collected, received, and/or stored prior to or at the beginning of the program. Such monitoring data may include one or more biometric measurements described herein. For example, monitoring data may include control values for heart rate, HRV, CO levels, and/or the like.

[283] A user may experience a decrease in CO levels. The risk of disenrollment can be determined based on CO levels monitored over time. A cigarette user's smoking history can be monitored. For example, if a user's monitored CO levels do not decrease as expected, or if the user's CO levels increase, a potential disenrollment can be identified. The program can be updated to address the potential disenrollment.

[284] Health improvements can be determined from HRV, HR, CO levels and blood pressure data and communicated to the user, for example to encourage the user to remain in the program.

[285] Behavioral support data may be collected at the beginning of the program and tracked throughout the program to personalize the program. For example, the user may enter data related to motivation, self-control, and addiction. The application may identify (e.g., the user and/or the program may infer this based on the user's data) the cigarettes that are easiest to quit. Smoking urge management strategies may be entered by the user. Smoking urge management strategies may be created and presented to the user. For example, smoking urge management strategies may be created based on the user's behavioral support data tracked over time and/or behavioral support data from other users. Potential program dropout may be predicted based on the behavioral support data, and appropriate behavior change recommendations may be communicated to the user.

[286] As described in this document, cigarette and/or tobacco and/or e-cigarette and/or e-smoking product use and/or NRT use can be tracked along with triggers, location, and time. Location tracking data can be used to determine location-based behavioral support. Urges to consume nicotine or smoke cigarettes can be tracked during program implementation. Risk of disengagement from the NRT program can be determined based on whether a user uses NRT more frequently than recommended. The program can be updated to address potential disengagement.

[287] FIG. 22 shows an example of a flow chart for updating an NRT program. As shown, a recommended program 2202 can be generated by the system 2200 based on the control biometric data 2204 and the nicotine addiction, nicotine consumption habits, and/or behavioral data 2206. The recommended program 2202 can be executed by the system 2200 as an NRT program 2208. The NRT program 2208 can be updated continuously based on the program adaptation data and certain user activity, such as falling behind in the smoking cessation program.

[288] As the user progresses through each stage of the NRT program 2208, the system 2200 may use the control biometric data 2204 and the nicotine addiction, nicotine consumption habits, and/or behavioral data 2206 to determine whether the user is on schedule, behind schedule, or ahead of schedule. If the user is on schedule, the system 2200 may not recommend any changes to the initially recommended program 2202. If the user is behind schedule, the system 2200 may determine whether the delay is due to a single smoking event or multiple smoking events. If the user is behind schedule due to a single smoking event, then some behavioral intervention (e.g., urge management techniques) may be suggested to help the user get back on schedule. If the user falls behind schedule due to multiple smoking episodes (e.g., a behavioral trend has been identified), System 2200 may recommend extending the initially recommended Program 2202, giving the user more time to return to schedule. If the user is ahead of schedule, System 2200 may recommend reducing the initially recommended Program 2202.

[289] FIG. 23A shows an example of a flow chart for identifying a particular model and updating a user's personalized NRT program based on the identified model. As shown in the figure, models 2304 can be used to change the user's personalized NRT program 2302. Models 2304 can be identified by analyzing (e.g., continuously analyzing) various data. These various data can include data 2306 on the number of cigarettes smoked, biometric data 2308, data 2310 on triggers and/or data 2312 on actions.

[290] FIG. 23B shows an example of a flow chart for identifying a particular model and updating NRT programs for a plurality of users based on the identified model. As shown, models 2322 can be used to modify personalized NRT programs 2320A-2320E for users. Models 2322 can be identified by analyzing (e.g., continuously analyzing) various data. These various data can include data 2324 on the number of cigarettes smoked, biometric data 2326, data 2328 on triggers and/or data 2330 on actions from a plurality of users (e.g., users from the NRT community, users with similar demographic information). Models 2322 can be used to develop personalized and modify existing NRT programs 2320A-2320E for a plurality of users. For example, models 2322 can be used to generate recommendations for replacing a particular type of cigarette with NRT therapy. The 2322 models can be used to generate recommendations that initiate NRT as part of the NRT reduction process.

[291] FIG. 24 shows examples of biometric indicators due to smoking. As shown, at step 2402, the biometric data may change before the smoking marker 2404. At step 2406, the biometric data may change after the smoking marker 2404. In FIG. 24, the time relative to the smoking marker 2404 is shown in seconds. Examples of biometric data that may influence HR include HR 2408, skin temperature 2410, and arousal/GSR 2412. For example, HR 2408 may begin to increase approximately two and a half minutes (-150 seconds, as shown in FIG. 24) before users begin smoking at point 2402 (before smoking marker 2404), and may decrease approximately two and a half minutes (150 seconds, as shown in FIG. 24) after users smart smoking at point 2406 (after smoking marker 2404). For example, skin temperature 2410 may increase (e.g., steadily increase) at point 2402 before users begin smoking (before smoking marker 2404), and it may decrease immediately after they begin smoking at the position of smoking marker 2404 and after smoking at point 2406. The increase in skin temperature 2410 before smoking marker 2404 may occur even though users may frequently (e.g., most often) smoke outdoors. For example, arousal/GSR 2412 may increase one to two minutes before smoking marker 2404. Arousal/GSR 2412 may decrease sharply (e.g., decrease instantly) before smoking marker 2404 and may increase (e.g., increase again) for approximately thirty seconds after smoking marker 2404.

[292] In examples, smoking cessation in habitual smokers can affect blood pressure and heart rate variability. As described in Minami et al. (Minami, Junichi, Toshihiko Ishimitsu, and Hiroaki Matsuoka. Effects of smoking cessation on blood pressure and heart rate variability in habitual smokers. Hypertension 33.1 (1999): 586–590), a study of blood pressure, heart rate, and heart rate variability was conducted in 39 normotensive male heavy smokers with an average age of approximately 33 years in an outpatient setting. Participants were divided into groups: 19 smokers were randomly assigned to abstain for one week and (for example) smoke for one week, and 23 smokers were randomly assigned to smoke for one week and (for example) smoke for one week. These participants had their blood pressure measured using volumetric compression oscillometry every 30 minutes on the last day of each period, and their R-R interval was measured on a five-minute ECG recording taken on the last day of each period. The results showed that smokers had higher blood pressure (e.g., systolic: 3.5 mmHg, diastolic: 1.9 mmHg, but only during the daytime), higher heart rate (e.g., 7.3 bpm), lower LF values, lower HF values, and a higher LF/HF ratio (e.g., but only during the daytime).

[293] In the examples of 24-hour trends in BP and HR measured during the smoking and abstinence periods and with an average number of cigarettes smoked per hour, during the smoking period, daytime BP was significantly lower during the abstinence period than during the smoking period, while nighttime BP did not differ for these two periods (e.g., did not differ significantly). In the examples, daytime and nighttime HR values were significantly lower during the abstinence period than during the smoking period. In the examples of 24-hour trends in the LF component, HF component, and LF/HF ratio measured during the smoking and abstinence periods and with an average number of cigarettes smoked per hour during the smoking period, the LF and HF components were higher (e.g., significantly higher) in both the daytime and nighttime during the abstinence period than during the smoking period. In the examples of 24-hour LF/HF ratio trends, the daytime LF/HF ratio was significantly lower during the abstinence period than during the smoking period, whereas the nighttime LF/HF ratio did not differ between the two periods (i.e., did not differ significantly).

[294] In examples, smoking cessation and nicotine patches may affect heart rate variability. As described in Stein et al. (Stein, Phyllis K., Jeffrey N. Rottman, and Robert E. Kleiger. Effect of 21 mg transdermal nicotine patches and smoking cessation on heart rate variability. The American journal of cardiology 77.9 (1996): 701–705), 54 male smokers, with a mean (SD) age of approximately 43 (12) years, wanted to quit, smoked at least one pack of cigarettes per day, and had made at least one previous quit attempt. Of these, 35 smokers used 21 mg patches for four to six weeks, and 25 smokers stopped using the patches within four weeks. In the results measured on 24-hour ECG recordings during the cessation period, smoking cessation resulted in a decrease (e.g., a significant decrease) in heart rate and an increase in all 24-hour indices of the time and frequency domains of heart rate variability. Some of these changes may occur during the transition from smoking to patches, and additional changes may occur upon discontinuing patch use. In the results measured four weeks after complete cessation of all nicotine use, the mean heart rate remained elevated, and heart rate variability remained reduced compared to values recorded for healthy middle-aged adults.

[295] In examples, smoking cessation may influence heart rate variability in long-term male smokers. As described in Harte et al. (Harte, Christopher B., and Cindy M. Meston. Effects of smoking cessation on heart rate variability among long-term male smokers. International journal of behavioral medicine 21.2 (2014): 302–309), 62 male smokers aged 23 to 60 years who had smoked more than 15 cigarettes/day for at least five years were enrolled in an eight-week transdermal nicotine patch therapy program. Of these, 20 successfully quit smoking, and 42 smokers failed to quit. Participants' heart rate variability was assessed at baseline (e.g., when they were regularly smoking), during treatment (e.g., when they were using high-dose patches), and at a follow-up period four weeks after patch use was discontinued, using a three-lead electrocardiogram (ECG) recorded over a four-hour period at the study center. The 20 successful quitters, compared with the 42 unsuccessful smokers, had higher (e.g., significantly higher) levels of SDNN, RMSSD, pNN50, LF, and HF at the follow-up period when they were nicotine- and smoke-free.

[296] In examples, smoking can affect resting heart rate, heart rate during exercise, and heart rate recovery in young adults. As described in Papathanasiou et al. (Papathanasiou, George, et al. Effects of smoking on heart rate at rest and during exercise, and on heart rate recovery, in young adults. Hellenic J Cardiol 54.3 (2013): 168–177), a sample of 298 adults aged 20 to 29 years with normal BMI and normal blood pressure was tested. The study included 79 nonsmoking women, 60 smoking women, 86 nonsmoking men, and 73 smoking men. Smokers smoked at least 20 cigarettes/day for at least three years, and nonsmokers had never smoked. Heart rate was measured using a 12-lead ECG during the Bruce maximal exercise test; HR was measured during exercise, at peak exercise, and after stopping exercise. Smokers had higher (e.g., significantly higher) resting HR values than non-smokers. Both male and female smokers demonstrated a slower (e.g., significantly slower) increase in HR during exercise. Female smokers missed the age-predicted maximum HR by 6.0 bpm, while male smokers missed it by 3.6 bpm. The actual maximum HR (HRmax) achieved was significantly lower in both female (191.0 bpm vs. 198.0 bpm) and male smokers (193.2 bpm vs. 199.3 bpm) compared to non-smokers. Heart rate reserve was also lower (e.g., significantly lower) in both female smokers (114.6 bpm vs. 128.1 bpm) and male smokers (120.4 bpm vs. 133.0 bpm). During recovery, the decline in heart rate was slower (e.g., significantly slower), but only in female smokers. Women had higher resting heart rates and demonstrated higher heart rates in response to submaximal exercise compared to men.

[297] FIG. 25 shows an example of a flow chart for modifying a user-personalized NRT program based on various sources of biometric data and sources of nicotine consumption data. The NRT program 2502 may be modified based on various factors. For example, at step 2504, the stage of the NRT program 2502 may be determined. The stage of the program may be determined on a weekly basis. Based on the stage of the program, an expected range of biometric data and/or nicotine consumption data may be determined at step 2506. For example, at some point in the cigarette smoking cessation program, the expected CO levels may shift toward levels characteristic of non-smokers. For example, at some point in the cigarette smoking cessation program, the expected HR value may be 10 bpm below the user's control HR. The expected range of biometric/nicotine consumption data may include data from one or more biometric data sources, nicotine consumption data sources, and/or various combinations of HR, HRV, resting heart rate (RHR), CO, respiration rate, NRT, number of cigarettes, other NRT consumption data.

[298] As shown in FIG. 25, at step 2510, it may be determined whether the user is following the program as scheduled by comparing the current biometric data and/or nicotine consumption data at point 2508A, the recently obtained biometric data and/or nicotine consumption data at point 2508B, and the original biometric data and/or nicotine consumption data at point 2508C with the expected biometric data and/or nicotine consumption data at point 2506.

[299] If it is determined at step 2510 that the user is executing the program in compliance with the schedule, no changes may be made to the NRT program 2502 at step 2512. If it is determined at step 2510 that the user is not on schedule, it may be determined at step 2514 whether the user is behind schedule, or it may be determined at step 2522 whether the user is ahead of schedule. If it is determined at step 2522 that the user is ahead of schedule, it may be determined at step 2524 whether the user is ahead of schedule only once. If a negative answer is received at step 2524, and if it is determined that the user has been ahead of schedule multiple times (e.g., multiple instances of exceeding the threshold have been observed), the NRT program 2502 may be shortened at step 2528. If a positive response is received at step 2524 and if it is determined that the user is ahead of schedule, but this was an isolated occurrence or occurred infrequently, no changes may be made to the recommended program at step 2526. If a user is determined to be behind schedule at step 2514, it may be determined at step 2516 whether the user was behind schedule on an isolated occasion. If a negative response is received at step 2516 and if it is determined that the user was behind schedule on multiple occasions (e.g., multiple threshold exceedances were observed), at step 2520, the NRT program 2502 may be extended compared to the original recommended program. If a positive response is received at step 2516 and if it is determined that the user is behind schedule on an isolated occurrence or occurred infrequently, at step 2518, a behavioral intervention recommendation may be indicated to the user. The behavioral intervention may include providing (e.g., sending a text message, displaying a notification, or the like) motivation to continue performing the NRT program 2502, encouraging the user to begin performing breathing exercises, encouraging the user to deploy one or more strategies and/or distraction techniques for overcoming urges, encouraging the user to analyze target indicators, etc.

[300] FIG. 26 is an example of a flow chart for identifying a smoking urge. When a nicotine/smoking urge is detected, NRT may be recommended to alleviate the smoking urge. If the onset of smoking urges correlates with certain locations or times of day, behavioral intervention and/or a recommendation to use NRT to alleviate the smoking urge (e.g., before the onset of smoking urges) may be provided. As the user progresses through each stage in the recommended program, the system may apply a range of data to determine whether the user is experiencing nicotine/smoking urges. The types of data applied may include collected biometric data. The collected biometric data may include measured GSR values and skin temperature values at step 2604A, HR values, HRV values and blood pressure values at step 2604B, SPO2 values at step 2604C and/or accelerometer readings at step 2604D, such as restlessness (e.g., which may be associated with an NRT dispenser).

[301] For example, at step 2602, the biometric data can be analyzed periodically (e.g., weekly). At step 2606, it can be determined whether significant changes have occurred in the periodically analyzed biometric data. If a negative response is received at step 2606 and no changes are determined, at step 2602, the periodic analysis of the monitored biometric data can continue. If a positive response is received at step 2606 and significant changes are determined (e.g., one or more changes exceeding a threshold are determined), at step 2608, it can be determined whether the user's current or recent activity indicates an urge to smoke. For example, the user's current or recent activity can be determined at step 2610 based on accelerometer readings from the user (e.g., data detected and transmitted by a smartwatch). If the user's activity at step 2608 does not indicate a smoking urge, the periodic analysis of the monitored biometric data may continue at step 2602. If the user's activity at step 2608 indicates a smoking urge, then at step 2612, the urge is identified. If the smoking urge is identified, at step 2614, the user may be provided with a behavioral intervention recommendation. The behavioral intervention may be or include providing (e.g., sending a text message, displaying a notification, etc.) motivation to continue the NRT program, encouraging the user to begin breathing exercises, encouraging the user to deploy one or more strategies and/or distraction techniques for overcoming urges, encouraging the user to analyze target indicators, etc. A behavioral intervention may be identified at step 2616 based on location, time, previous cigarette consumption, cigarette consumption trends, triggers for cigarette smoking or NRT consumption, and/or cigarette smoking or NRT consumption trends. At step 2618, it may be determined whether the behavioral intervention at step 2614 results in an improvement in sensor data. If a positive response is received at step 2618 and the behavioral intervention at step 2614 results in an improvement in sensor data, no further intervention may be required at step 2620. If a negative response is received at step 2618 and the behavioral intervention does not result in an improvement in sensor data, then a suggestion for NRT use may be provided at step 2622.

[302] FIG. 27 is an example of a behavioral intervention flow chart. As the user progresses through each stage of the NRT program 2701, the system may use the measured biometrics to determine a relapse to cigarette smoking. If the user's cigarette smoking was not determined, the system may not make any changes to the recommended program. If cigarette smoking was determined, the system may further determine whether the smoking was a single event or whether there were multiple smoking episodes. If the smoking was a single event, a behavioral intervention may be recommended to help the user return to the schedule. If there were multiple cigarette smoking episodes, the system may recommend extending the program, which will give the patient more time to return to the schedule.

[303] As shown in FIG. 27, a current CO level 2702A and a previous CO level 2702B can be compared. Current and previous biometric data, such as GSR values, skin temperature values, HR values, HRV values, blood pressure values, SPO2 values, can be compared at step 2704. At step 2706, it can be determined whether there are changes between the current and previous values. If a negative answer is received at step 2706 and there are no changes in the readings or the changes are insignificant, then the recommended program can remain the same as at step 2708. If a positive answer is received at step 2706 and changes in the readings are determined (e.g., a significant change, such as one or more changes exceeding a threshold value), a smoking event can be identified at step 2710. At step 2712, it can be determined whether such an event was the first or whether such events occurred rarely. If a positive response is received at step 2712 and it is determined that the smoking episode was the first or that such episodes were infrequent, then at step 2714 the user may be given a behavioral intervention recommendation, as described herein. If a negative response is received at step 2712 and it is determined that the smoking episodes were numerous or that such episodes were frequent, the NRT program 2701 may be extended at step 2716 beyond the recommended program.

[304] CO levels can be measured in parts per million (COppm). Values greater than 100 COppm may indicate the heaviest smokers and are rarely measured. Values of 50-99 COppm may be seen in smokers who smoke two or more packs of cigarettes per day. Values of 36-19 COppm may be seen in smokers who smoke one and a half packs of cigarettes per day. Values of 20-35 COppm may be seen in smokers who smoke one pack of cigarettes per day. Values of 11-19 COppm may be seen in smokers who smoke less than one pack of cigarettes per day. Values of 7-10 COppm may be seen in smokers who smoke a small number of cigarettes per day, but their level of dependence may be high, especially if they obtain nicotine from multiple sources. Values of 0-6 COppm can be found in nonsmokers and those who have recently quit smoking. In examples, current smokers can be distinguished from smokers who have abstained for the previous eight hours using a cutoff level of 12 COppm with a specificity of 94% and a sensitivity of 90% (see Sandberg, AnnSofi, et al., "Assessing recent smoking status by measuring exhaled carbon monoxide levels." PLoS One 6.12 (2011): e28864). For example, in observational analyses among current smokers smoking 1 cigarette/day, higher smoking severity was associated with higher (0.21 bpm; 95% confidence interval, 0.19, 0.24) resting heart rate and higher (e.g., slightly elevated) diastolic blood pressure (0.05 mmHg; 95% confidence interval, 0.02, 0.08) and systolic blood pressure (0.08 mmHg; 95% confidence interval, 0.03, 0.13) (see Linneberg, Allan, et al. Effect of smoking on blood pressure and resting heart rate: a Mendelian randomization metaanalysis in the CARTA consortium. Circulation: Cardiovascular Genetics 8.6 (2015): 832–841).

[305] FIG. 28 shows an example of a smoking cessation program with multiple phases. As shown in the figure, the smoking cessation program 2802 may include a cigarette reduction phase 2804, a stabilization phase 2806, and a nicotine reduction phase 2808. During the cigarette reduction phase 2804, the number of cigarettes smoked may be reduced, or cigarettes may be eliminated entirely and replaced with NRT. NRT may act as a replacement for cigarettes to provide (e.g., temporarily provide) users with nicotine while reducing or eliminating the number of cigarettes smoked. In examples, the cigarette reduction phase 2804 may represent the first phase in the smoking cessation program 2802 (e.g., during weeks 1-4 of the smoking cessation program 2802). In the cigarette reduction phase 2804, users may have a similar (e.g., somewhat similar) total nicotine intake, but may reduce the number of cigarettes smoked or eliminate them entirely, using NRT instead as a nicotine source. In the stabilization phase 2806, cigarettes may be eliminated entirely, and NRT intake may remain unchanged or decrease. The stabilization phase 2806 may represent the second phase in a smoking cessation program (e.g., during weeks 5-8 of the smoking cessation program 2802). In the stabilization phase 2806, users may consume the same amount of nicotine or a lower amount of nicotine while completely eliminating cigarettes. Instead, users in the stabilization phase 2806 may completely use NRT as a source of nicotine intake. In the NRT reduction phase 2808, NRT must be reduced or eliminated in order to reduce or eliminate the users' nicotine intake. The NRT reduction phase may be the third and final phase of the 2802 smoking cessation program (e.g., during weeks 9-12 of the 2802 smoking cessation program). During the 2808 NRT reduction phase, users must adhere to a schedule to completely eliminate nicotine from their system.

[306] Each of the cigarette reduction phase 2804, the stabilization phase 2806, and the NRT consumption reduction phase 2808 may be performed sequentially. For example, the stabilization phase 2806 may not begin until the user completes the cigarette reduction phase 2804, and the NRT consumption reduction phase 2808 may not begin until the user completes the stabilization phase 2806. Depending on the overall condition of the users, which may be measured by various biometric indicators, as described in the examples herein, each of the cigarette reduction phase 2804, the stabilization phase 2806, and the NRT consumption reduction phase 2808 may be extended or shortened. Phase prolongation may mean extending the phase's duration, decreasing the amount by which the number of cigarettes smoked and/or NRT consumption is reduced during the phase, decreasing the rate of reduction in the number of cigarettes smoked and/or NRT consumption during the phase, and/or returning to the previous phase. Phase shortening may mean shortening the phase's duration, increasing the amount by which the number of cigarettes smoked and/or NRT consumption is reduced during the phase, and/or accelerating the rate of reduction in the number of cigarettes smoked and/or NRT consumption during the phase.

[307] FIG. 29 is a flow chart of an example of a smoking cessation program that provides personalized nicotine replacement therapy. The smoking cessation program 2902 may utilize data collection 2904, event determination 2914, and program interventions and/or program modifications 2924 to generate a personalized nicotine replacement therapy 2932. Data collection 2904 may be used to generate or trigger an event determination 2914. Event determination 2914 may be used to generate or trigger program interventions and/or program modifications 2924. Data collection 2904 may include collection of biomarkers 2906, user data 2908, program change history 2910, and medical records 2912. Biomarkers 2906 may include CO levels, GSR values, skin temperature values, HR values, HRV values, blood pressure values, SP02 values, and the like. User data 2908 may include personal data such as body weight, height, BMI, smoking history and/or other nicotine product use, current and/or previous health conditions, as well as family history, etc. Program change history 2910 may include any previous data about the user collected by the smoking cessation program 2902 and/or similar smoking cessation programs. In examples, program change history 2910 may include (for example, may also include) any previous data about users with similar physical conditions, similar smoking history, physical characteristics, and/or health conditions. Medical documentation 2912 may include medical documentation related to smoking and nicotine replacement therapy.

[308] The event determination 2914 may include a smoking urge detection event 2916, a program intervention event 2918, a smoking detection event 2920, and a behavioral intervention event 2922. The smoking urge detection event 2916 may be determined by administering biomarkers, which are described in more detail herein. The program intervention event 2918 may be determined by administering biomarkers and/or by determining a change in the number of cigarettes smoked, the amount of NRT consumed, and a certain amount of carbon monoxide, which are described in more detail herein. The smoking detection event 2920 may be determined by biomarkers and/or by a certain amount of carbon monoxide, which are described in more detail herein. The behavioral interference event 2922 may be determined through biomarkers, whereby the user may be prompted to deploy one or more strategies and/or distraction techniques to overcome urges, or the user may be prompted to check targets, etc.

[309] The program interventions and/or program modifications 2924 may include determining 2926 a phase, determining 2928 a phase duration, and determining 2930 a behavioral therapy. In examples, data collection 2904 and event determination 2914 may be used to determine 2926 a phase to determine whether the user is in the appropriate phase of the smoking cessation program 2902. If the answer is positive, the user may continue to follow the recommended smoking cessation program. Otherwise, the user may return to the previous phase of the smoking cessation program 2902 or move to the next phase of the smoking cessation program 2902. In examples, data collection 2904 and event determination 2914 may be used to determine 2928 a phase duration to determine whether the appropriate phase duration for the user is being applied in the smoking cessation program 2902. If the answer is positive, the user may continue to follow the recommended smoking cessation program. Otherwise, the user can extend the duration of the phase in the smoking cessation program 2902 that he is currently in, or the user can shorten (e.g., decrease) the duration of the phase in the smoking cessation program 2902 that he is currently in. In examples, for determining 2930 behavioral therapy, data collection 2904 and determining 2914 events can be used to determine the type of behavioral therapy for the user. The types of behavioral therapy can include providing (e.g., sending a text message, displaying a notification, or the like) motivation to continue performing the smoking cessation program 2902, which encourages the user to begin performing breathing exercises, encourages the user to deploy one or more strategies and/or distraction techniques for overcoming urges, encourages the user to analyze target indicators, and the like. Each action from the program interventions and/or program modifications 2924 can be applied to the recommended smoking cessation program to update the personalized nicotine replacement therapy 2932.

[310] FIG. 30 shows an example of a flow chart for a modification to a smoking cessation program. The program modification 3002 may be applied to determine a urge to consume nicotine at step 3004. In examples, if a urge to consume nicotine was determined at step 3004, the program may suggest applying NRT to alleviate the urge to smoke at step 3008. In examples, if a urge to consume nicotine was determined at step 3004, the program may (for example, may also) perform a behavioral therapy component to alleviate the urge to smoke 300. The program modification 3002 may be applied at step 3006 to determine smoking occurrences. In examples, if a smoking occurrence was determined at step 3006, the program may perform a behavioral therapy component to alleviate the urge to smoke at step 3010.

[311] The modification 3002 of the program may be applied at step 3012 to determine trends. If any trend was determined at step 3012, the program may be extended at step 3014 or shortened at step 3016. In examples, if the program was extended at step 3014, the program may reduce the rate of reduction in the number of cigarettes smoked if the program is in the reduction phase of the number of cigarettes smoked, or may reduce the rate of reduction in NRT consumption if the program is in the nicotine reduction phase 3018, which is described in detail herein. In examples, if the program was extended at step 3014, at step 3020 the program may return to the previous phase (e.g., move from the reduction phase of the amount of nicotine consumption to the stabilization phase). In examples, if the program was extended at step 3014, at step 3022 the program may extend the duration of the phase (e.g., use of NRT during the stabilization phase). In examples, if the program was extended at step 3014, at step 3024 the program may reduce the rate of reduction in the number of cigarettes smoked/NRT consumption (e.g., reduce every two weeks instead of once a week, etc.).

[312] In examples, if the program was shortened at step 3016, at step 3026 the program may increase the rate of reduction in the number of cigarettes smoked and/or NRT consumption (e.g., if in the reduction phase or in the nicotine reduction phase the number of cigarettes smoked/NRT consumption was reduced by 50% instead of 25%). In examples, if the program was shortened at step 3016, at step 3028 the program may shorten the duration of the phase (e.g., using NRT in the stabilization phase). In examples, if the program was shortened at step 3016, at step 3030 the program may increase the rate of reduction in the number of cigarettes smoked/NRT consumption (e.g., reducing the number of cigarettes/NRT every few days instead of once a week).

[313] FIG. 31A shows an example of a flow chart of a smoking urge detection event. FIG. 31B shows an example of a table for determining a smoking urge detection event. As shown in FIG. 31A, a smoking urge detection event 3102 may be determined by a number of biomarkers 3104. The biomarkers 3104 may include GSR 3106, skin temperature 3108, and/or HR 3110. As shown in FIG. 31B, each of the biomarkers 3104 may be used as input data 3112 of the smoking urge event to determine output data 3114 of the smoking urge event. The output data 3114 of the smoking urge event may indicate the presence or absence of the urge to smoke. As shown in FIG. 31B, the positive predictive value 3116 of the urge to smoke (PPV of the urge) can be calculated using the input data 3112 of the urge to smoke event. The PPV 3116 of the urge can be calculated by dividing the number of input data 3112 of the urge to smoke event for which a positive predictive value of the urge to smoke was obtained by the total number of input data 3112 of the urge to smoke event.

[314] As shown in FIG. 31B, the urge event input data 3112 that represents a positive predictive indicator of the urge to smoke is shaded, and the urge event input data 3112 that represents a negative predictive indicator of the urge to smoke is not shaded. In examples, the urge event input data 3112 may be designated UP or DOWN compared to previously measured urge event input data. In examples, the urge event input data 3112 about GSR 3106 may be designated UP or DOWN compared to a previously measured GSR value. In examples, the urge event input data 3112 about HR 3110 may be designated UP or DOWN compared to a previously measured HR value. In the examples, the skin temperature 3108 urge event input may be labeled UP or DOWN compared to a previously measured skin temperature value.

[315] As shown in FIG. 31B, the urge to smoke event input data 3112 of the GSR 3106, labeled DOWN, is shaded and may represent a positive predictive indicator of the urge to smoke, and the urge to smoke event input data 3112 of the GSR 3106, labeled UP, is not shaded and may represent a negative predictive indicator of the urge to smoke. The urge to smoke event input data 3112 of the HR 3110, labeled UP, is shaded and may represent a positive predictive indicator of the urge to smoke, and the urge to smoke event input data 3112 of the HR 3110, labeled DOWN, is not shaded and may represent a negative predictive indicator of the urge to smoke. The urge event input 3112 about skin temperature 3008, labeled UP (Above), is shaded and may represent a positive predictive indicator of the urge to smoke, and the urge event input 3112 about skin temperature 3008, labeled DOWN (Below), is not shaded and may represent a negative predictive indicator of the urge to smoke.

[316] In examples, if one set of urge event input data 3112 out of three sets of urge event input data 3112 is shaded and represents a positive predictive indicator of urge to smoke, this may cause the urge event output data 3114 to indicate CRAVING. If one set of urge event input data 3112 out of three sets of urge event input data 3112 is shaded and represents a positive predictive indicator of urge to smoke, the urge PPV 3116 may be 33.33% (1/3). In examples, if two sets of urge event input data 3112 out of three sets of urge event input data 3112 are shaded and represent a positive predictive indicator of urge to smoke, this may result in the urge event output data 3114 indicating CRAVING. If two sets of urge event input data 3112 out of three sets of urge event input data 3112 are shaded and represent a positive predictive indicator of urge to smoke, the urge PPV 3116 may be 66.67% (2/3). In examples, if three sets of urge event input data 3112 out of three sets of urge event input data 3112 are shaded and represent a positive predictive indicator of urge to smoke, this may result in the urge event output data 3114 indicating CRAVING. If three sets of urge event input data 3112 out of three sets of urge event input data 3112 are shaded and represent a positive predictive indicator of urge to smoke, the urge PPV 3116 may be 100% (3/3). In the examples, if none of the urge event input data sets 3112 of the three urge event input data sets 3112 are shaded and do not represent a positive predictive indicator of urge to smoke, this may result in the urge event output data 3114 indicating NO CRAVING. If none of the urge event input data sets 3112 of the three urge event input data sets 3112 are shaded and do not represent a positive predictive indicator of urge to smoke, the urge PPV 3116 may be 0% (0/3).

[317] FIG. 32A shows an example of a program intervention event flow chart. FIGS. 32B-32C show an example of tables for determining a program intervention event. As shown in FIG. 32A, a program intervention event 3202 may be determined by measuring data collection metrics 3204. The data collection metrics 3204 may include cigarette consumption 3206, NRT consumption 3208, carbon monoxide level 3210, RHR 3212, HRV 3214, and/or blood pressure 3216. As shown in FIG. 32B, some of the data collection metrics 3204 may be used as program intervention inputs 3218 to determine program intervention outputs. In examples, the program intervention inputs 3218 may be cigarette consumption 3206, NRT consumption 3208, and/or carbon monoxide level 3210.

[318] Smoking cessation programs may include a cigarette reduction phase 3222, a stabilization phase 3224, and a nicotine reduction phase 3226. The cigarette reduction phase 3222 may include a cigarette reduction phase output 3230. The stabilization phase 3224 may include a stabilization phase output 3234. The NRT reduction phase 3226 may include an NRT reduction phase output 3238. Each of the sets of cigarette reduction phase output 3230, stabilization phase output 3234, and NRT reduction phase output 3238 may be determined by program intervention inputs 3218.

[319] In the cigarette reduction phase 3222, the number of cigarettes smoked may be reduced, or cigarettes may be eliminated entirely and replaced with NRT. NRT may act as a replacement for cigarettes to provide (e.g., temporarily provide) users with nicotine while reducing or eliminating the number of cigarettes smoked. In examples, the cigarette reduction phase 3222 may be the first phase in a smoking cessation program (e.g., during weeks 1-4 of a smoking cessation program). In the stabilization phase 3224, cigarettes may be eliminated entirely and NRT consumption may remain unchanged or decrease. The stabilization phase 3224 may be the second phase in a smoking cessation program (e.g., during weeks 5-8 of a smoking cessation program). In the NRT reduction phase 3226, NRT must be reduced or eliminated to reduce or eliminate nicotine consumption by users. Phase 3226 of the NRT reduction program may represent the third and final phase of the smoking cessation program (e.g., during weeks 9-12 of the smoking cessation program). During Phase 3226 of the NRT reduction program, users must adhere to a schedule to completely eliminate nicotine from their system.

[320] In examples, the program intervention input 3218 may be designated UP or DOWN compared to previously measured urge event input. In examples, the program intervention input 3218 on cigarette consumption 3206 may be designated UP or DOWN compared to previously measured number of cigarettes smoked. In examples, the program intervention input 3218 on NRT consumption 3208 may be designated UP or DOWN compared to previously measured NRT consumption. In examples, the program intervention input 3218 on carbon monoxide level 3210 may be designated UP or DOWN compared to previously measured carbon monoxide level.

[321] In the cigarette reduction phase 3222, if the program intervention input data 3218 about cigarette consumption 3206, NRT consumption 3208, and carbon monoxide level 3210 are indicated as UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the cigarette reduction phase 3222 may be extended, which may be indicated by the cigarette reduction phase output data 3230 as EXTEND. If the program intervention input data 3218 on cigarette consumption 3206 is designated UP, the NRT consumption data 3028 is designated DOWN, and the carbon monoxide level data 3210 is designated UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the cigarette reduction phase 3222 may be extended, which may be indicated by the cigarette reduction phase output data 3230 as EXTEND. If the program intervention input data 3218 for cigarette consumption 3206 is marked DOWN, the NRT consumption data 3028 is marked UP, and the carbon monoxide level data 3210 is marked DOWN, the user may be considered to be on schedule with his or her smoking cessation program, which may be indicated by the output data 3230 of the reduction phase as ON TRACK. If the program intervention input data 3218 on cigarette consumption 3206 is designated DOWN, the NRT consumption data 3028 is designated DOWN, and the carbon monoxide level data 3210 is designated DOWN, the user may be considered to be ahead of schedule in his or her quit smoking program, and the cigarette reduction phase 3222 may be shortened (e.g., completed quickly), which may be indicated by the cigarette reduction phase output data 3230 as TRUNCATE. As shown in FIG. 32B, some of the program intervention input data 3218 and the cigarette reduction phase output data 3230 are shaded, which may indicate that such a combination of program intervention input data and/or cigarette reduction phase output data 3230 may not exist. In these cases, the output data of the 3230 cigarette reduction phase may be designated N/A.

[322] In the stabilization phase 3224, if the program intervention input data 3218 about cigarette consumption 3206, NRT consumption 3208, and carbon monoxide level 3210 are indicated as UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the stabilization phase 3224 may be extended, which may be indicated by the stabilization phase output data 3234 as EXTEND. If the program intervention input data 3218 for cigarette consumption 3206 is designated UP, the NRT consumption data 3028 is designated DOWN, and the carbon monoxide level data 3210 is designated UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the stabilization phase 3224 may be extended, which may be indicated by the stabilization output data 3234 as EXTEND. If the program intervention input data 3218 for cigarette consumption 3206 is designated DOWN, the NRT consumption data 3028 is designated UP, and the carbon monoxide level data 3210 is designated DOWN, the user may be considered to be behind schedule in his or her smoking cessation program, and the stabilization phase 3224 may be extended, which may be indicated by the stabilization output data 3234 as EXTEND. If the program intervention input data 3218 on cigarette consumption 3206 is designated DOWN, the NRT consumption data 3028 is designated DOWN, and the carbon monoxide level data 3210 is designated DOWN, the user may be considered to be ahead of schedule in his or her cessation program, and the stabilization phase 3224 may be shortened (e.g., quickly completed), which may be indicated by the stabilization phase output data 3234 in the form of the inscription TRUNCATE. As shown in FIG. 32B, some program intervention input data 3218 and stabilization phase output data 3234 are shaded, which may indicate that such a combination of program intervention input data and/or stabilization phase output data 3230 cannot exist. In these cases, the stabilization phase output data 3230 may be designated N/A.

[323] In the NRT reduction phase 3226, if the program intervention input data 3218 about cigarette consumption 3206, NRT consumption 3208, and carbon monoxide level 3210 are indicated as UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the NRT reduction phase 3226 may be extended, which may be indicated by the NRT reduction phase output data 3238 as EXTEND. If the program intervention input data 3218 for cigarette consumption 3206 is UP, the NRT consumption data 3028 is DOWN, and the carbon monoxide level data 3210 is UP, the user may be considered to be behind schedule in his or her smoking cessation program, and the NRT reduction phase 3226 may be extended, which may be indicated by the NRT reduction phase output data 3238 as EXTEND. If the program intervention input data 3218 for cigarette consumption 3206 is designated DOWN, the NRT consumption data 3028 is designated UP, and the carbon monoxide level data 3210 is designated DOWN, the user may be considered to be behind schedule in his or her smoking cessation program, and the NRT reduction phase 3226 may be extended, which may be indicated by the NRT reduction phase output data 3238 as EXTEND. If the program intervention input data 3218 on cigarette consumption 3206 is marked DOWN, the NRT consumption data 3028 is marked DOWN, and the carbon monoxide level data 3210 is marked DOWN, the user may be considered to be on schedule with his or her smoking cessation program, which may be indicated by the NRT reduction phase output data 3238 as ON TRACK. As shown in FIG. 32B, some program intervention input data 3218 and NRT reduction phase output data 3238 are shaded, which may indicate that such a combination of program intervention input data and/or NRT reduction phase output data 3238 cannot exist. In these cases, the NRT reduction phase output data 3238 may be marked N/A.

[324] As shown in FIG. 32B, some (e.g., some other) data collection metrics 3204 may be used as program intervention inputs 3218 to determine program intervention outputs 3240. In examples, program intervention inputs 3218 may be RHR 3212, HRV 3214, and/or blood pressure 3216. Program intervention outputs 3240 shown in FIG. 32B may be used to verify and/or supplement cigarette reduction phase outputs 3230, stabilization phase outputs 3234, and NRT reduction phase outputs 3238 shown in FIG. 32B.

[325] As shown in FIG. 32B, the program intervention inputs 3218 that represent a positive predictive indicator of the need to extend the phase are shaded, and the program intervention inputs 3218 that represent a negative predictive indicator of the need to extend the phase are not shaded. In examples, the program intervention inputs 3218 may be designated UP or DOWN compared to previously measured program intervention inputs. In examples, the program intervention inputs 3218 about RHR 3212 may be designated UP or DOWN compared to previously measured RHR values. In examples, the program intervention inputs 3218 about HRV 3214 may be designated UP or DOWN compared to previously measured HRV values. In examples, the input data 3218 of the program intervention about blood pressure 3216 may be designated UP (Higher) or DOWN (Lower) in comparison with a previously measured blood pressure.

[326] As shown in FIG. 32B, the program intervention input data 3218 about RHR 3212, labeled UP, is shaded and may represent a positive predictive indicator of prolongation of the phase, and the program intervention input data 3218 about RHR 3212, labeled DOWN, is not shaded and may represent a negative predictive indicator of prolongation of the phase. The program intervention input data 3218 about HRV 3214, labeled DOWN, is shaded and may represent a positive predictive indicator of urge to smoke, and the program intervention input data 3218 about HRV 3214, labeled UP, is not shaded and may represent a negative predictive indicator of prolongation of the phase. The input data 3218 of the blood pressure program intervention 3216, labeled UP (above), are shaded and may represent a positive predictive indicator of prolongation of the phase, and the input data 3218 of the blood pressure program intervention 3216, labeled DOWN (Below), are not shaded and may represent a negative predictive indicator of prolongation of the phase.

[327] In examples, if one set of program intervention input data 3218 out of three sets of program intervention input data 3218 is shaded and represents a positive predictive indicator of urge to smoke, this may cause the program intervention output data 3240 to indicate EXTEND. In examples, if two sets of program intervention input data 3218 out of three sets of program intervention input data 3218 are shaded and represent a positive predictive indicator of urge to smoke, this may cause the program intervention output data 3240 to indicate EXTEND. In examples, if three sets of program intervention input data 3218 out of three sets of program intervention input data 3218 are shaded and represent a positive predictive indicator of urge to smoke, this may cause the program intervention output data 3240 to indicate EXTEND. In the examples, if none of the sets of program intervention input data 3218 of the three sets of program intervention input data 3218 are shaded and do not represent a positive predictor of urge to smoke, this may cause the program intervention output data 3240 to indicate ON TRACK.

[328] FIG. 33A shows an example of a flow chart of a smoking detection event. FIG. 33B shows an example of a table for determining a smoking detection event. As shown in FIG. 33A, a smoking detection event 3302 may be determined by measuring data collection metrics 3304. The data collection metrics 3304 may include a heart rate 3306, a skin temperature 3308, a GSR 3310, and/or a carbon monoxide level 3312. As shown in FIG. 33B, each of the data collection metrics 3304 may be used as input data 3314 of a smoking event determination to determine a smoking event output data 3316. The smoking event output data 3316 may indicate that a smoking event has occurred, a smoking event is unlikely, a smoking event is possible, a smoking event is unlikely, or that a smoking event is absent.

[329] As shown in FIG. 33B, the smoking event input data 3314 that represents a positive predictive indicator of the smoking event are shaded, and the smoking event input data 3314 that represents a negative predictive indicator of the smoking event are not shaded. In examples, the smoking event input data 3314 may be designated UP or DOWN compared to the previously measured smoking event input data 3314. In examples, the carbon monoxide level 3312 smoking event input data 3314 may be designated UP or DOWN compared to the previously measured carbon monoxide level. In examples, the heart rate 3306 smoking event input data 3314 may be designated UP or DOWN compared to the previously measured heart rate value. In examples, the smoking event input data 3314 about skin temperature 3308 may be designated as UP (Higher) or DOWN (Lower) compared to a previously measured skin temperature value. In examples, the smoking event input data 3314 about GSR 3310 may be designated as UP (Higher) or DOWN (Lower) compared to a previously measured GSR value.

[330] As shown in FIG. 33B, the smoking event input data 3314 of the carbon monoxide level 3310, labeled UP, is shaded and may represent a positive predictive indicator of the smoking event, and the smoking event input data 3314 of the carbon monoxide level 3310, labeled DOWN, is not shaded and may represent a negative predictive indicator of the smoking event. The smoking event input data 3314 of the heart rate 3306, labeled DOWN, is shaded and may represent a positive predictive indicator of the smoking event, and the smoking event input data 3314 of the heart rate 3110, labeled UP, is not shaded and may represent a negative predictive indicator of the smoking event. The smoking event input data 3314 about skin temperature 3308, designated DOWN, are shaded and may represent a positive predictive indicator of the smoking event, and the smoking event input data 3314 about skin temperature 3008, designated UP, are not shaded and may represent a negative predictive indicator of the smoking event. The smoking event input data 3314 about GSR 3310, designated UP, are shaded and may represent a positive predictive indicator of the smoking event, and the smoking event input data 3314 about GSR 3310, designated DOWN, are not shaded and may represent a negative predictive indicator of the smoking event.

[331] In examples, if the carbon monoxide level 3310 is shadowed without the other (e.g., one of the other three) sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating NOT LIKELY SMOKING EVENT. In examples, if the carbon monoxide level 3310 is shadowed with another (e.g., one of the other three) set of smoking event input data 3314, this may result in the smoking event output data 3316 indicating POSSIBLE SMOKING EVENT. In the examples, if the carbon monoxide level 3310 is shadowed with two other (e.g., out of three other) sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating LIKELY SMOKING EVENT. In the examples, if the carbon monoxide level 3310 is shadowed with three other (e.g., out of three other) sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating SMOKING EVENT.

[332] In examples, if the carbon monoxide level 3310 is not obscured in the absence of other (e.g., of the other three) unobscured sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating NO SMOKING EVENT. In examples, if the carbon monoxide level 3310 is not obscured in the presence of another (e.g., of the other three) unobscured set of smoking event input data 3314, this may result in the smoking event output data 3316 indicating NOT LIKELY SMOKING EVENT. In the examples, if the carbon monoxide level 3310 is not obscured in the presence of two (e.g., out of three other) unobscured sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating NOT LIKELY SMOKING EVENT. In the examples, if the carbon monoxide level 3310 is not obscured in the presence of three (e.g., out of three other) unobscured sets of smoking event input data 3314, this may result in the smoking event output data 3316 indicating NOT LIKELY SMOKING EVENT.

[333] FIG. 34 shows a method for providing nicotine replacement therapy that can be implemented by a device. This device may include a dispenser housing. This device may include a dispenser for dispensing a nicotine composition. This device may include a drive element mounted to actuate the dispenser. This device may include a carriage mounted to move relative to the dispenser housing upon contact with the drive element. This device may include a sensor that may be configured to sense movement of the carriage.

[334] This device may comprise a locking mechanism movable between an operating position that allows the drive element to move so as to operate the dispenser, and an inoperative position in which movement of the drive element is prevented. The device may comprise a transmitter for sending a nicotine amount signal, which may indicate the amount of nicotine that may have been consumed by the user previously. This device may comprise a receiver for receiving a locking signal, which may indicate that the locking mechanism requires movement to the inoperative position. This device may comprise a sensor for measuring a physiological parameter.

[335] This device may comprise a processor that may be configured to perform one or more of the actions shown for method 3400. For example, the device may perform one or more of actions 3402, 3404, 3406, 3408, 3410, 3412 and/or any combination thereof.

[336] At step 3402, a sensor signal, a biomarker, and/or a physiological parameter may be obtained. This sensor signal, biomarker, and/or physiological parameter may be used as described herein. For example, the biomarker may be used to determine the user's nicotine consumption, the user's cessation phase, the user's progress within the cessation phase, the user's health indicator, the urge to consume nicotine, and/or the like.

[337] In one example, a sensor signal may be received from a sensor for measuring a physiological parameter, which may indicate a value of a physiological parameter of a user. The value of the physiological parameter of the user may be determined based on the sensor signal. The value of the physiological parameter of the user may be sent, for example, to the user and/or to a device. The physiological parameter may be any biometric parameter and/or biomarker as described herein.

[338] In one example, data may be received from a sensor. The data may include one or more of heart rate, heart rate variability, blood pressure, temperature, respiratory rate, oxygen saturation level, carboxyhemoglobin level, carbon monoxide level, galvanic skin reflex, and accelerometer data received from a portable device associated with the user. A personalized nicotine replacement therapy program or nicotine reduction program may be modified for the user based on the data received from the portable device.

[339] At step 3404, an urge to consume nicotine may be determined. The urge to consume nicotine may be determined using user input, biomarkers, a sensor signal, a physiological parameter, a history of nicotine consumption, and the like. In one example, a motion signal may be received from a motion sensor. Based on the motion signal, it may be determined that the user is in a restless state for a period of time. The user's restlessness may indicate that the user may be experiencing an urge to consume nicotine. An indication (e.g., a notification) of the restless state, such as an urge to consume nicotine, may be sent to the user and/or a device, such as a smartphone.

[340] In one example, it may be determined that the user is experiencing an urge to consume nicotine using at least one of detected motion, physical location, time of day, scheduled activity, the user's calendar, social media data, and a biometric measurement. In one example, it may be determined that the user is experiencing an urge to consume nicotine using a resting heart rate associated with the user or using a noticeable change in the user's heart rate.

[341] In one example, the onset time of a predicted urge to smoke may be determined. For example, the onset time of the predicted urge to smoke may be determined using one or more of: the time of delivery of the first portion of the nicotine formulation and the amount of nicotine that has previously been consumed by the user. At the onset time of the predicted urge to smoke, a notification may be sent prompting the user to administer a second portion of the nicotine formulation.

[342] In one example, the onset time of a predicted urge to smoke may be determined, and/or a smoking abstinence event may be determined. Heart rate data associated with a user may be received. A heart rate trend and/or a heart rate change trend for the user may be determined using the received heart rate data. An expected time of occurrence of a smoking abstinence event may be determined.

[343] A command, message, and/or signal may be sent. For example, a message may be sent requesting that a user dispense a nicotine formulation at or before the expected time of occurrence of a smoking abstinence event. In one example, a signal may be sent to a nicotine dispensing device commanding the nicotine dispensing device to dispense and/or allow a user to dispense a nicotine formulation at or before the expected time of occurrence of a smoking abstinence event. In one example, a message may be sent commanding an actuator to actuate a dispenser so that the dispenser dispenses an amount of nicotine formulation at or before the expected time of occurrence of a smoking abstinence event.

[344] At step 3406, the amount of nicotine that was previously consumed by the user can be determined. In one example, the amount of nicotine previously consumed can be determined using a dispenser actuation counter. The number of actuations of the dispenser can be determined. The number of actuations of the dispenser can relate to and/or be associated with a period of time. The concentration of the nicotine formulation can be determined. The amount of nicotine consumed by the user during a period of time can be determined based on the number of actuations and the concentration of the nicotine formulation. The amount of nicotine previously consumed by the user can be determined based on the amount of nicotine consumed by the user during a period of time.

[345] In one example, the amount of nicotine previously consumed by a user may be determined based on one or more tobacco products that may have been consumed by the user over a period of time. A nicotine level associated with one or more tobacco products may be determined. For example, a nicotine level for an e-cigarette that the user may have smoked may be determined.

[346] In one example, a total amount of nicotine consumed may be determined. The total amount of nicotine consumed may indicate an amount of nicotine that was previously consumed by the user. An amount of nicotine to be dispensed may be determined. The user may be permitted to dispense the nicotine formulation when the total amount of nicotine consumed and the amount of nicotine to be dispensed may be less than the maximum daily nicotine serving. For example, the actuator may be commanded to actuate the dispenser so that the dispenser dispenses an amount of nicotine when the total amount of nicotine consumed and the amount of nicotine to be dispensed are less than the maximum daily nicotine serving. The user may be prohibited from dispensing the nicotine formulation when the total amount of nicotine consumed and the amount of nicotine to be dispensed combined are greater than or equal to the maximum daily nicotine serving.

[347] At step 3408, a nicotine threshold value for the user may be determined. The nicotine threshold value may take into account nicotine consumption from one or more sources, such as cigarettes, smokeless tobacco, electronic cigarettes, heated tobacco, a nicotine formulation, nicotine gum, and the like. The nicotine threshold value may be personalized for the user. The nicotine threshold value may be based on the age of the user, the body weight of the user, the cessation phase in which the user is, the intensity of nicotine consumption by the user, and the like. The nicotine threshold value may be determined to prevent the user from consuming a lethal dose of nicotine, an excessive dose of nicotine, an amount of nicotine that may be harmful for cessation of nicotine consumption, and/or the like.

[348] In one example, it may be determined that the amount of nicotine that was previously consumed by the user may be greater than or equal to a nicotine threshold. It may be determined that the user is not allowed to consume an additional amount of nicotine. The lockout mechanism may be instructed to prevent the dispensing of the nicotine formulation from the dispenser (e.g., at step 3410).

[349] In one example, it may be determined that the amount of nicotine that was previously consumed by the user may be below a nicotine threshold. It may be determined that the user may consume an additional amount of nicotine. A message (e.g., a notification) may be sent to the user recommending that they dispense a dose of nicotine, for example, to reduce the urge to consume nicotine. The lockout mechanism may be instructed to allow the dispensing of the nicotine formulation from the dispenser (e.g., at step 3410).

[350] In one example, a nicotine threshold for a user may be determined using one or more smoking behavior patterns of the user. For example, one or more smoking behavior patterns of the user may be determined. A smoking cessation program for the user may be determined based on one or more smoking behavior patterns of the user.

[351] At step 3410, a signal, such as a signal for a locking mechanism, and/or a message may be sent to the locking mechanism. In one example, the signal for the locking mechanism may cause the locking mechanism to move to an operative position. For example, it may be determined that the user has not exceeded the nicotine threshold, is experiencing an urge to consume nicotine, and/or is permitted to consume nicotine. In addition, a signal may be sent that causes the locking mechanism to move and/or remain in an operative position so that the user can dispense a nicotine formulation.

[352] In one example, a signal to the locking mechanism may cause the locking mechanism to move to an inoperative position. In one example, it may be determined that the amount of nicotine previously consumed by the user may exceed a nicotine threshold. And a signal to the locking mechanism may be sent if the amount of nicotine previously consumed by the user exceeds the nicotine threshold to cause the locking mechanism to move to an inoperative position.

[353] In one example, it may be determined that the user may experience an urge to consume nicotine (e.g., at step 3402) and that some condition may indicate that the user should not take a portion of the nicotine formulation. And a signal may be sent to the locking mechanism for the locking mechanism, which may cause the locking mechanism to move to an inoperative position (e.g., even though the user may experience an urge to consume nicotine).

[354] In one example, the locking mechanism may be included in another device, which may be a nicotine delivery device. A message may be sent to the nicotine delivery device to cause the nicotine delivery device to deliver a dose of nicotine.

[355] At step 3412, a portion of the nicotine composition may be dispensed. For example, the device may dispense the nicotine composition. In another example, the device may send a message and/or signal to the nicotine delivery device to dispense the nicotine composition.

[356] In one example, a portion of a nicotine formulation may be dispensed. The portion of the nicotine formulation may be determined based on a signal from a sensor, as described herein. An indication of the portion of the nicotine formulation may be sent. For example, a user may be notified of the portion of the nicotine formulation. In another example, a message indicating the portion of the nicotine formulation may be sent to a smartphone.

[357] It is possible to determine the time at which a portion of the nicotine composition was dispensed. And the time can be indicated in the indication of the portion.

[358] A device for providing nicotine replacement therapy may be provided. This device may comprise a dispenser for dispensing a nicotine composition. This device may comprise an actuator mounted to actuate the dispenser. This device may comprise a locking mechanism that may be movable between an operating position that allows the actuator to move so as to actuate the dispenser, and an inoperative position in which movement of the actuator may be impossible. The device may comprise a processor. The processor may be configured to determine the amount of nicotine that has previously been consumed by the user. The processor may be configured to send a signal to the locking mechanism for the locking mechanism that causes the locking mechanism to move to the inoperative position.

[359] In one example, a nicotine threshold value may be determined for the user, wherein the nicotine threshold value may take into account nicotine consumption from one or more sources. It may be determined whether the amount of nicotine that has been previously consumed by the user may exceed the nicotine threshold value, and if the amount of nicotine that has been previously consumed by the user exceeds the nicotine threshold value, a signal may be sent to the locking mechanism that causes the locking mechanism to move to an inoperative position.

[360] In one example, the device may comprise a transmitter that may be used to send a nicotine quantity signal indicating the amount of nicotine that has previously been consumed by the user. The device may comprise a receiver that may be used to receive a lock signal that may indicate that the lock mechanism needs to be moved to an inoperative position.

[361] In one example, the device may comprise a sensor for measuring a physiological parameter.

[362] In one example, the device may comprise a transmitter, and the processor may be configured to receive a sensor signal from a sensor for measuring a first physiological parameter, which indicates the value of the first physiological parameter of the user. The value of the first physiological parameter of the user may be determined based on the sensor signal. The transmitter may receive a command to send the value of the first physiological parameter of the user.

[363] In one example, the processor may be configured to determine a number of dispenser actuations associated with a period of time. A concentration of the nicotine formulation may be obtained. The amount of nicotine consumed by the user during the period of time may be determined based on the number of actuations and the concentration of the nicotine formulation, and the amount of nicotine previously consumed by the user may be determined based on the amount of nicotine consumed by the user during the period of time.

[364] In one example, the processor may be configured to determine that the user is experiencing an urge to consume nicotine and that the condition indicates that the user should not consume a portion of the nicotine formulation, wherein upon determining that the user is experiencing an urge to consume nicotine, a signal is sent to the locking mechanism to cause the locking mechanism to move to an inoperative position.

[365] In one example, the device may comprise a motion sensor, and the processor may be configured to receive a motion signal from the motion sensor. Based on the motion signal, it may be determined that the user is in a restless state for a period of time. An indication of the user's restless state may be sent.

[366] A device for providing nicotine replacement therapy may be provided. The device may comprise a memory device and a processor. The processor may be configured to perform a method. It may be determined that a user experiences an urge to consume nicotine. The amount of nicotine that has previously been consumed by the user may be determined. A nicotine threshold for the user may be determined. It may be determined that the amount of nicotine previously consumed by the user is below the nicotine threshold. A message may be sent to the user recommending that a portion of nicotine be dispensed to reduce the urge to consume nicotine.

[367] In one example, the message may be a first message, and the processor may be configured to send a second message to the nicotine delivery device instructing the nicotine delivery device to allow the delivery of a portion of nicotine.

[368] In one example, the processor may be configured to determine that the user may be experiencing an urge to consume nicotine using at least one of detected motion, physical location, time of day, scheduled activity, the user's calendar, social media data, and a biometric measurement.

[369] In one example, the processor may be configured to determine that the user is experiencing an urge to consume nicotine using a resting heart rate associated with the user or using a noticeable change in the user's heart rate.

[370] In one example, the processor may be configured to determine the amount of nicotine that has been previously consumed by the user. For example, one or more tobacco products consumed by the user over a period of time may be determined. A nicotine level associated with the one or more tobacco products may be determined.

[371] In one example, the processor is further configured to determine a nicotine threshold for the user. For example, one or more smoking behavior patterns of the user may be determined. A smoking cessation program for the user may be determined based on the one or more smoking behavior patterns of the user.

[372] A device for providing nicotine replacement therapy may be provided. The device may comprise a dispenser housing. The device may comprise a dispenser for dispensing a portion of a nicotine composition. The device may comprise a drive element mounted to actuate the dispenser. The device may comprise a carriage mounted to move relative to the dispenser housing upon contact with the drive element. The device may comprise a sensor configured to sense movement of the carriage. The device may comprise a processor. The processor may be configured to perform one or more actions. Based on a signal from the sensor, it may be determined that a portion of the nicotine composition has been dispensed. An indication of a portion of the nicotine composition may be sent.

[373] In one example, the carriage may be a magnetic carriage. The sensor may be a magnetic sensor configured to detect when the magnetic carriage is within a certain range.

[374] In one example, the processor may be configured to determine the time at which a portion of the nicotine composition was dispensed. The indication of the portion may further indicate the time.

[375] In one example, the portion of the nicotine composition may be a first portion, and the processor may be configured to determine the amount of nicotine that has previously been consumed by the user. The time of occurrence of the predicted urge to smoke may be determined using the time of delivery of the first portion of the nicotine composition and the amount of nicotine that has previously been consumed by the user. A notification may be provided offering a second portion of the nicotine composition at the time of occurrence of the predicted urge to smoke.

[376] In one example, the processor may be configured to receive heart rate data associated with a user. A heart rate trend and/or a heart rate change trend for the user may be determined using the received heart rate data. An expected time of occurrence of a smoking abstinence event may be determined. The drive element may be commanded to actuate the dispenser so that the dispenser dispenses an amount of nicotine formulation at or before the expected time of occurrence of a smoking abstinence event.

[377] In one example, the processor may be configured to receive data. This data may include one or more of heart rate, heart rate variability, blood pressure, temperature, respiratory rate, oxygen saturation level, carboxyhemoglobin level, carbon monoxide level, galvanic skin reflex, and accelerometer data received from a portable device associated with the user. A personalized nicotine replacement therapy program or nicotine reduction program for the user may be modified based on the received data from the portable device.

[378] In one example, the processor may be configured to determine a total amount of nicotine consumed. The total amount of nicotine consumed may indicate an amount of nicotine that was previously consumed by the user. An amount of nicotine to be dispensed may be determined. The actuator may be commanded to actuate the dispenser so that the dispenser dispenses an amount of nicotine when the total amount of nicotine consumed and the amount of nicotine to be dispensed are less than the maximum daily nicotine serving.

[379] FIG. 35 shows an example of a method for providing nicotine replacement therapy that may utilize a biomarker. This method may be performed by a device comprising a processor that may be configured to perform one or more of the actions shown for method 3500. For example, the device may perform one or more of actions 3502, 3504, 3506, and/or any combination thereof.

[380] At step 3502, a smoking cessation program may be determined for the user. The smoking cessation program may comprise one or more phases. A phase of the smoking cessation program may be determined in accordance with the description herein. The phase may be one of a reduction phase, a stabilization phase, and a reduction phase of the amount of nicotine consumed.

[381] At step 3504, a program intervention event may be determined. The program intervention event may be determined based on the phase of the smoking cessation program and/or a marker associated with the user.

[382] The program intervention event may be one or more of a smoking urge detection event, a smoking detection event, and a behavioral intervention event. In one example, it may be determined that a user's behavioral intervention may be recommended. It may be determined that a previously recommended behavioral intervention may not produce the desired effect. A modification to the smoking cessation program and/or any phase of the smoking cessation program may be performed based on a determination that a previously recommended behavioral intervention did not produce the desired effect. The user may be offered a different behavioral intervention if it is determined that a previously recommended behavioral intervention did not produce the desired effect.

[383] The marker may comprise one or more of a cigarette count, nicotine consumption data, a user biomarker, a user behavior indicator, a smoking urge detection, and a smoking detection. The marker may comprise one or more of a heart rate, a resting heart rate, a heart rate variability, a blood pressure, a user temperature, a respiratory rate, an oxygen saturation level, a skin temperature, a carbon monoxide level detection, and a galvanic skin reflex.

[384] A program intervention event may be determined using the user's cigarette consumption rate. For example, the user's nicotine consumption rate may be determined. The user's carbon monoxide saturation level may be determined. The program intervention event may be based on the user's cigarette consumption rate, the nicotine consumption rate, and the user's carbon monoxide saturation level.

[385] The program intervention event may be a smoking detection event. For example, the smoking detection event may be determined based on a biomarker associated with the user.

[386] The program intervention event may be a nicotine consumption detection event. For example, the nicotine consumption detection event may be determined based on a biomarker associated with the user.

[387] At step 3506, a modification to the smoking cessation program may be determined. The modification to the smoking cessation program may be based on a program intervention event. The modification to the smoking cessation program may be one or more of an actual rate of reduction in the number of cigarettes smoked, a duration of the phase, a desired rate of reduction in the number of cigarettes smoked, an actual rate of reduction in the use of nicotine replacement therapy, and a desired rate of reduction in the use of nicotine replacement therapy.

[388] A modification to the smoking cessation program may be determined using a smoking cessation trend. The smoking cessation trend may be indicated by a program intervention event. The duration of any phase of the smoking cessation program may be modified based on the smoking cessation trend. For example, a program intervention event may indicate that the user has increased smoking intensity, the smoking cessation trend may indicate an increase in cigarette consumption, and the duration of the reduction phase may be increased.

[389] A modification to a smoking cessation program may be determined based on a phase and/or a smoking detection event. For example, the program intervention event may be a smoking detection event. It may be determined that the phase may be a cigarette reduction phase, and it may be determined that the cigarette reduction phase may be extended based on the smoking detection event.

[390] A modification to the smoking cessation program may be based on a biomarker, a biomarker trend, and/or a smoking detection event. If the biomarker trend is determined to have exceeded a threshold, the user may be transitioned to the second phase of the smoking cessation program. The cigarette consumption rate may be determined using the smoking detection event. The duration of the second phase of the smoking cessation program may be determined based on the cigarette consumption rate.

[391] A modification to the smoking cessation program may be determined based on the intensity of cigarette consumption. The intensity of cigarette consumption may be determined using a smoking event. It may be determined that a threshold value for a biomarker trend may have been exceeded. The intensity of consumption may be determined using a smoking detection event where the biomarker trend may have exceeded the threshold value. The duration of any phase of the smoking cessation program may be determined based on the intensity of cigarette consumption.

[392] A modification to the smoking cessation program may be based on the smoking cessation program and a program intervention event, which may be a smoking event. For example, the user's cigarette consumption rate may be determined using a smoking detection event. An increase in the duration of the first phase may be determined using a smoking detection event. The increase in the duration of the first phase may exceed a threshold. If the duration of the first phase exceeds the threshold, the user may be transferred to the second phase of the smoking cessation program.

[393] A modification to the smoking cessation program may be determined based on a phase and a nicotine consumption detection event. For example, the program intervention event may be a nicotine consumption detection event. It may be determined that the phase may be a cigarette reduction phase, and it may be determined that the cigarette reduction phase can be extended based on the smoking detection event. In an example, a modification to the smoking cessation program may include transitioning the user to a phase of the smoking cessation program, determining the nicotine consumption rate using the nicotine consumption detection event, and determining the duration of the smoking cessation program phase based on the nicotine consumption rate.

[394] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. The processor may be configured to perform one or more actions. A smoking cessation program may be defined for a user. An intervention event of the program may be determined based on a phase of the smoking cessation program. A marker associated with the user may be determined. A change in the smoking cessation program may be determined based on an intervention event of the program.

[395] In one example, the marker may comprise one or more of a cigarette count, nicotine consumption data, a user biomarker, a user behavior indicator, a smoking urge detection, and a smoking history detection.

[396] In one example, the marker may comprise one or more of heart rate, resting heart rate, heart rate variability, blood pressure, user temperature, respiratory rate, oxygen saturation level, skin temperature, carbon monoxide level detection, and galvanic skin reflex.

[397] In one example, the phase is one of a cigarette reduction phase, a stabilization phase, and a nicotine reduction phase.

[398] In one example, the program intervention event may be one or more of a smoking urge detection event, a smoking detection event, and a behavior intervention event.

[399] In one example, a modification to a smoking cessation program that may be based on a program intervention event may include changing one or more of the actual rate of reduction in the number of cigarettes smoked, the duration of the phase, the desired rate of reduction in the number of cigarettes smoked, the actual rate of reduction in the use of nicotine replacement therapy, and the desired rate of reduction in the use of nicotine replacement therapy.

[400] In one example, the marker may represent the rate of reduction of the user's cigarette consumption, and the processor may be configured to determine a program intervention event. For example, the user's rate of consumption of a nicotine formulation may be determined. The user's carbon monoxide saturation level may be determined. The program intervention event may be determined based on the user's rate of cigarette consumption, the rate of consumption of the nicotine formulation, and the user's carbon monoxide saturation level.

[401] In one example, a modification to a smoking cessation program may be determined using a smoking cessation trend. For example, a smoking cessation trend may be indicated by a program intervention event. The duration of a phase of the smoking cessation program may be changed based on the smoking cessation trend. In another example, a modification may be based on a determination that a biomarker trend may have exceeded a threshold.

A device for providing nicotine replacement therapy may be proposed. The device may comprise a processor configured to perform one or more actions. A smoking cessation program phase associated with the user may be determined. A smoking detection event may be determined based on a biomarker associated with the user. A modification to the smoking cessation program may be determined based on the smoking detection phase and event.

[402] In one example, the biomarker may be one or more of the user's associated carbon monoxide level, the user's heart rate, the user's skin temperature, and the user's galvanic skin reflex.

[403] In one example, the phase may be a first phase, and the processor may be configured to determine a modification to the smoking cessation program based on the first phase and a smoking detection event. For example, the user's cigarette consumption rate may be determined using a smoking detection event. An increase in the duration of the first phase may be determined based on the cigarette consumption rate. It may be determined that an increase in the duration of the first phase results in exceeding a threshold. The user may be transferred to the second phase of the smoking cessation program.

[404] In one example, the processor may be configured to determine that a biomarker trend may exceed a threshold. The biomarker trend may be associated with a particular biomarker.

[405] In one example, the phase may be a first phase, and the processor may be configured to determine a modification to the smoking cessation program based on the first phase and a smoking detection event. For example, if it is determined that the biomarker trend has exceeded a threshold, the user may be transferred to the second phase of the smoking cessation program. The cigarette consumption rate may be determined using the smoking detection event. The duration of the second phase of the smoking cessation program may be determined based on the cigarette consumption rate.

[406] In one example, the processor may be configured to determine a modification to the smoking cessation program based on the phase and the smoking detection event. The cigarette consumption rate may be determined using the smoking detection event if it is determined that the biomarker trend has exceeded a threshold. The duration of the smoking cessation program phase may be determined based on the cigarette consumption rate.

[407] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. The processor may be configured to determine a phase of a smoking cessation program associated with a user. An event of detecting the fact of nicotine consumption may be determined. A modification to the smoking cessation program may be determined based on the phase and the event of detecting the fact of nicotine consumption.

[408] In one example, the phase may be a first phase, and the processor may be configured to determine a modification to the smoking cessation program based on the first phase and nicotine consumption. If it is determined that nicotine consumption is below the nicotine threshold for the user, the user may be transferred to the second phase of the smoking cessation program. The intensity of nicotine consumption may be determined using the nicotine consumption detection event. The duration of the second stage of the smoking cessation program may be determined based on the intensity of nicotine consumption.

[409] FIG. 36 shows an example of a method for providing nicotine replacement therapy that may use a biomarker to detect an urge to consume nicotine. This method may be performed by a device comprising a processor that may be configured to perform one or more of the actions shown for method 3600. For example, the device may perform one or more of actions 3602, 3604, 3606, and/or any combination thereof.

[410] At step 3602, a biomarker associated with the user may be determined. The biomarker may be any biomarker described herein.

[411] At step 3604, a urge to consume nicotine may be determined. The urge to consume nicotine may be determined using a biomarker. For example, a second biomarker associated with the user may be determined. A predictive value may be calculated based on the first biomarker and/or the second biomarker. The predictive value may indicate the likelihood that the user may experience a urge to consume nicotine. It may be determined that the user may experience a urge to consume nicotine when the predictive value exceeds a threshold.

[412] The urge to consume nicotine may be determined using one or more biomarkers. For example, the galvanic skin response associated with the user may be determined. The user's heart rate may be determined. The user's skin temperature may be determined. The urge to consume nicotine may be determined using the galvanic skin response, heart rate, and skin temperature.

[413] At step 3606, an intervention may be provided to the user. The intervention may be a behavioral intervention, a nicotine replacement therapy intervention, a combination thereof, and/or the like. The intervention may be aimed at reducing tobacco consumption, nicotine consumption, e-cigarette consumption, cigarette consumption, and/or the like.

[414] Intervention may be delivered to the user based on the urge to consume nicotine and the phase of the smoking cessation program. The phase of the smoking cessation program may be associated with a specific user.

[415] The intervention may be provided to the user based on the urge to consume nicotine and the phase by sending a notification to the user. The notification may contain one or more of an indication that the user can dispense a dose of the nicotine formulation, behavioral therapy instructions, an indication of an action the user can take to reduce the urge to consume nicotine, and an indication of a biomarker.

[416] An intervention may be a modification to a smoking cessation program and/or a phase of a smoking cessation program. For example, an intervention may be modified during a phase based on the smoking cessation trend.

[417] A device for providing nicotine replacement therapy may be provided. The device may comprise a processor. A biomarker associated with the user may be determined. Using the biomarker associated with the user, an urge to consume nicotine may be determined. The user may be offered an intervention based on the urge to consume nicotine.

[418] In one example, the biomarker may be a first biomarker, and the processor may be configured to determine an urge to consume nicotine using the first biomarker and/or the second biomarker. For example, the second biomarker may be associated with a specific user. A predictive value may be determined based on the first biomarker and/or the second biomarker. The predictive value may indicate the likelihood that the user may experience an urge to consume nicotine. It may be determined that the user may experience an urge to consume nicotine when the predictive value exceeds a threshold.

[419] In one example, the biomarker may be a galvanic skin response associated with the user, the processor may be configured to determine the urge to consume nicotine using the galvanic skin response. The user's heart rate may be determined. The user's skin temperature may be determined. The urge to consume nicotine may be determined using the galvanic skin response, heart rate, and skin temperature.

[420] In one example, the processor may be configured to determine a phase of a smoking cessation program associated with the user. Intervention may be provided to the user based on the urge to consume nicotine and the phase of the smoking cessation program.

[421] In one example, the intervention may be one or more of a behavioral intervention and a nicotine replacement therapy intervention, and the processor may be configured to provide the intervention to the user based on the urge to consume nicotine and the phase by sending a notification to the user. The notification may include one or more of an indication that the user can dispense a portion of the nicotine formulation, instructions for behavioral therapy, an indication of an action the user can take to reduce the urge to consume nicotine, and an indication of a biomarker.

[422] In one example, a modification to a smoking cessation program may be based on an intervention, a phase, and a biomarker. In one example, the processor may be configured to determine a smoking cessation trend, which may be indicated by the intervention, the phase, and the biomarker. The duration of the phase may be changed based on the smoking cessation trend.

[423] This application may relate to "determining" various pieces of information. Determining information may include, for example, one or more of evaluating information, computing information, predicting information, or retrieving information from memory.

[424] Furthermore, this application may relate to "receiving" various pieces of information. The term "receiving," like the term "accessing," is a broad term. Receiving information may include, for example, one or more of accessing information or retrieving information (e.g., from memory). Furthermore, typically, "receiving" is included in some way in operations such as storing information, processing information, transmitting information, moving information, copying information, deleting information, computing information, determining information, predicting information, or evaluating information.

[425] It should be noted that the use of any of the following: /, "and/or," and "at least one of," such as in the cases of "A/B," "A and/or B," and "at least one of A and B," implies the selection of only the first option from the list (A), or the selection of only the second option from the list (B), or the selection of both options (A and B). In a further example, in the cases of "A, B and/or C" and "at least one of A, B, and C," such wording implies the selection of only the first item from the list (A), or the selection of only the second item from the list (B), or the selection of only the third item from the list (C), or the selection of only the first and second items from the list (A and B), or the selection of only the first and third items from the list (A and C), or the selection of only the second and third items from the list (A and B and C), or the selection of all three items (A and B and C). As will be understood by those skilled in the art and related fields, this provision may be extended to as many elements as are contained in the list.

[426] A number of examples are described herein. The features of these examples may be provided in claims of various categories and types, individually or in any combination. Furthermore, embodiments may include one or more of the following features, devices, or aspects provided in claims of various categories and types, individually or in any combination.

Claims (78)

1. A device for providing nicotine replacement therapy, comprising: a processor configured to: defining a smoking cessation program for the user; determining the sensor signal from the dispenser for dispensing the nicotine composition; determining the intensity of consumption of a nicotine composition associated with the user based on a sensor signal from a dispenser for dispensing a nicotine composition; determining the level of carbon monoxide saturation for the user; determining the event of detection of the fact of smoking if the level of carbon monoxide saturation exceeds the threshold value; determining the intensity of cigarette consumption by the user using the smoking detection event; determining the intervention event of the program based on the phase of the smoking cessation program, the intensity of consumption of the nicotine composition and the intensity of cigarette consumption, wherein the phase is one of the reduction phase of the number of cigarettes smoked, the stabilization phase or the reduction phase of the amount of nicotine consumed; determining the duration of the smoking cessation program phase based on the program intervention event and the intensity of cigarette consumption; and determining a modification to a smoking cessation program based on a program intervention event and a specified duration, wherein the modification increases the likelihood of smoking cessation. 2. The device of claim 1, wherein the processor is further configured to determine a marker comprising at least one of a count of the number of cigarettes smoked, nicotine consumption data, a user biomarker, a user behavior indicator, a determination of an urge to smoke, or a determination of the fact of smoking. 3. The device of claim 1, wherein the processor is further configured to determine a marker that is at least one of heart rate (HR), resting HR, HR variability, blood pressure, user temperature, respiratory rate, oxygen saturation level, skin temperature, carbon monoxide level determination, or galvanic skin reflex. 4. The device of claim 1, wherein the program intervention event is at least one of a detection event of an urge to smoke, a detection event of the fact of smoking, or a behavioral intervention event. 5. The device of claim 1, wherein the modification to the smoking cessation program comprises changing at least one of the rate of reduction in the number of cigarettes smoked, the duration of the phase, the desired rate of reduction in the number of cigarettes smoked, the rate of reduction in the use of nicotine replacement therapy, or the desired rate of reduction in the use of nicotine replacement therapy. 6. The device of claim 1, wherein the processor is configured to determine a modification in the smoking cessation program based on the program intervention event and the specified duration by: determining the smoking cessation trend indicated by the program intervention event; and changes in the duration of the smoking cessation program phase based on the smoking cessation trend. 7. A device for providing nicotine replacement therapy, comprising: a receiver for receiving a sensor signal from a dispenser for dispensing a nicotine composition; a processor configured to: user-associated biomarker definitions; determining the level of carbon monoxide saturation for the user; determining the intensity of consumption of a nicotine composition associated with the user based on a sensor signal from a dispenser for dispensing a nicotine composition; determining the event of detection of the fact of smoking if the level of carbon monoxide saturation exceeds the threshold value; determining the intensity of cigarette consumption by the user using the smoking detection event; defining the program intervention event based on the phase of the smoking cessation program, the intensity of nicotine composition consumption, and the intensity of cigarette consumption; determining the duration of the smoking cessation program phase based on the program intervention event and the intensity of cigarette consumption; determining the urge to consume nicotine using a user-associated biomarker; and providing the user with an intervention based on the duration of the specified phase and the urge to consume nicotine, whereby the intervention increases the likelihood of quitting smoking. 8. The device of claim 7, wherein the biomarker is a first biomarker, and the processor is configured to determine the urge to consume nicotine using the first biomarker associated with the user by: determining a second biomarker associated with the user; calculating a predictive value based on the first biomarker and the second biomarker, wherein the predictive value indicates the likelihood that the user experiences an urge to consume nicotine; and determining that the user experiences an urge to consume nicotine if the predictive value exceeds the predictive threshold value. 9. The device of claim 7, wherein the biomarker is a galvanic skin reflex associated with the user, and the processor is configured to determine the urge to consume nicotine using the galvanic skin reflex associated with the user by: determining the user's heart rate; determining the user's skin temperature; and determining the urge to consume nicotine using the galvanic skin reflex, heart rate and skin temperature. 10. The device according to claim 7, wherein the processor is further configured to: determining the phase of the smoking cessation program associated with the user. 11. The device of claim 10, wherein the intervention is at least one of a behavioral intervention and a nicotine replacement therapy intervention, and wherein the processor is configured to provide an intervention to the user based on the duration of the phase and the urge to consume nicotine by sending a notification to the user, wherein the notification comprises at least one of an indication that the user should dispense a portion of the nicotine formulation, instructions for behavioral therapy, an indication of an action that the user can take to reduce the urge to consume nicotine, or an indication of a biomarker. 12. The device of claim 10, wherein the processor is further configured to determine a modification in the smoking cessation program based on the intervention and the duration of the phase. 13. The device according to claim 10, in which the processor is further configured to: determining the smoking cessation trend indicated by the intervention, phase and biomarker; and changes in the duration of the phase based on the smoking cessation trend. 14. A device for providing nicotine replacement therapy, comprising: a processor configured to: determining the phase of the smoking cessation program associated with the user; determining the level of carbon monoxide saturation for the user; determining the sensor signal from the dispenser for dispensing the nicotine composition; determining the intensity of consumption of a nicotine composition associated with the user based on a sensor signal from a dispenser for dispensing a nicotine composition; determining the event of detection of the fact of smoking if the level of carbon monoxide saturation exceeds the threshold value; determining the intensity of cigarette consumption by the user using the smoking detection event; defining the program intervention event based on the phase of the smoking cessation program, the intensity of nicotine composition consumption, and the intensity of cigarette consumption; determining the duration of the smoking cessation program phase based on the program intervention event and the intensity of cigarette consumption; and determining modifications to a smoking cessation program based on phase and duration, with modifications increasing the likelihood of smoking cessation. 15. The device of claim 14, wherein the processor is further configured to determine a biomarker that is at least one of a carbon monoxide level associated with the user, a heart rate of the user, a skin temperature of the user, or a galvanic skin reflex of the user. 16. The device of claim 14, wherein the phase is a first phase, and wherein the processor is configured to determine a modification in the smoking cessation program based on the first phase and duration by: determining the increase in duration based on at least the intensity of cigarette consumption; determining that the increase in duration will exceed the duration threshold; and transferring the user to the second phase of the smoking cessation program. 17. The device of claim 16, wherein the phase is a first phase and the duration is a first duration, and wherein the processor is configured to determine a modification in the smoking cessation program based on the first phase and duration by: moving the user to the second phase of the smoking cessation program if the biomarker trend is determined to have exceeded the threshold; and determining the second duration for the second phase of the smoking cessation program based at least on the intensity of cigarette consumption. 18. A device for providing nicotine replacement therapy, comprising: a processor configured to: determining the phase of the smoking cessation program associated with the user; determining the level of carbon monoxide saturation for the user; determining the sensor signal from the dispenser for dispensing the nicotine composition; determining the intensity of consumption of a nicotine composition associated with the user based on a sensor signal from a dispenser for dispensing a nicotine composition; determining the event of detection of the fact of nicotine consumption if the level of carbon monoxide saturation exceeds the threshold value; defining the program intervention event based on the phase of the smoking cessation program, the intensity of nicotine composition consumption, and the intensity of cigarette consumption; determining the duration of the smoking cessation program phase based on the program intervention event and the intensity of cigarette consumption; and determining a modification in a smoking cessation program based on the phase, duration, and event of detection of nicotine consumption, wherein the modification increases the likelihood of smoking cessation. 19. The device of claim 18, wherein the phase is a first phase, and wherein the processor is configured to determine a modification in the smoking cessation program based on the first phase, the duration, and the event of detecting the fact of nicotine consumption by: transferring the user to the second phase of the smoking cessation program if it is determined that the nicotine intake is below the user's nicotine threshold; determining the intensity of nicotine consumption using the event of detection of the fact of nicotine consumption and the intensity of consumption of the nicotine composition; and determining the second duration for the second phase of the smoking cessation program based on the intensity of nicotine consumption.