Tailored NRT Integrated with Smartphone Behavioral Support

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 DESCRIPTION (provided by applicant): The CDC states that smoking causes 80% of lung cancers and 443,000 deaths annually and is the leading preventable cause of death in the USA. Smokers have peak cravings at predictable times, but existing NRTs are not tailored to preempt cravings. Further, NRT is often used in isolation from behavioral support despite data supporting the benefits of traditional and mobile-based interventions. Finally, innovation is needed in mobile-based cessation interventions to deliver evidence-based programming that also generates a positive user experience and ongoing utilization. Chrono Therapeutics, Inc. (CTI) has developed, patented and clinically tested in humans a technology, SmartStop(tm) (SS or SmartStop), for programmed and patient-individualized pulsatile nicotine replacement therapy (NRT) for smoking cessation. With $2.23M in grant support from the NCI, CTI is in the advanced stages of developing SS for manufacture as a `smart' wearable NRT device that counteracts nicotine withdrawal by tailoring NRT to pre-empt smokers' predictable craving patterns. The NRT component of the SS project is funded by the NCI grant and private funds. In this project, CTI will add (i) a behavioral support component via a smoking cessation mobile application, Digital Coach (DC), (ii) a SmartPhone Communication Application (SCA) that serves as the conduit for secure data exchange between SS and a Back End database which will be shared with Digital Coach, (iii) wireless communication technology built into the SS device to allow data transfer to the mobile components and (iv) a mechanism to SS and DC for tracking of craving episodes, allowing smarter more tailored coaching support. It is also our objective, but not part of this proposal, to add sensor-based compliance monitoring to SS. CTI believes that the combination of smart NRT, smart behavioral support and compliance monitoring will increase smoking cessation efficacy to 32% or greater. SmartStop, CTI's `smart' NRT device with wireless communication capability will be integrated with SCA and DC to provide (i) `smart' optimally-timed cravings management and behavioral interventions based on widely accepted psychological principles and synchronized with SS's delivery of NRT and (ii) a real-time sensor-based compliance monitoring system that delivers, via smartphone, algorithm-based, personalized and proactive messaging to encourage proper utilization of, and compliance with, the SS device. The key technical and therapeutic innovations in SS are (i) the integration of patient-individualized NRT and a behavioral intervention (via a paired smartphone) that is optimally timed to the NRT regimen and (ii) the creation of unique behavioral support content and algorithms to ensure synchronized and complementary programmable NRT and behavioral support based on smokers' actual NRT use and reported craving patterns.