CHRONO THERAPEUTICS, INC. — Department of Health and Human Services SBIR Phase I: 102

Description

DESCRIPTION provided by applicant The CDC states that smoking causes of lung cancers and 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 $ M in grant support from the NCI CTI is in the advanced stages of developing SS for manufacture as a `smartandapos wearable NRT device that counteracts nicotine withdrawal by tailoring NRT to pre empt smokersandapos 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 or greater SmartStop CTIandapos s `smartandapos NRT device with wireless communication capability will be integrated with SCA and DC to provide i `smartandapos optimally timed cravings management and behavioral interventions based on widely accepted psychological principles and synchronized with SSandapos 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 smokersandapos actual NRT use and reported craving patterns PUBLIC HEALTH RELEVANCE According to the Centers for Disease Control and Prevention cigarette smoking causes the vast majority of lung cancers and over deaths annually with a total monetary cost exceeding $ billion While the majority of the million US smokers want to quit a small fraction of this number actually succeeds Chrono Therapeutics Inc CTI plans to produce a programmable wristwatch like device SmartStopTM integrated with real time behavioral intervention that delivers tailored doses of nicotine through a patch in pulses throughout the day to preempt the regular craving and peak smoking episodes that smokers experience synched to the delivery of andquot smartandquot tailored mobile phone based behavioral intervention thereby significantly increasing the efficacy of nicotine replacement therapy and prolonging or saving millions of lives