Programmable Individualized NRT Merged With Digital Behavioral Support

Project Summary AbstractThe CDC states that smoking causesof lung cancers anddeaths annually and is the leading preventable cause of death in the USASmokers have peak cravings at predictable timesbut existing NRTs are not tailored to preempt cravingsFurtherNRT is often used in isolation from behavioral support despite data supporting the benefits of traditional and mobile based interventionsChrono TherapeuticsIncCTIhas developedpatented and clinically tested in humans a smoking cessation systemSCSfor programmed and patient individualized pulsatile nicotine replacement therapyNRTpaired with behavioral change techniques for smoking cessationSCS is the first system that can automatically tailor nicotine plasma throughout the day based on the consistentdailypredictable craving patterns that smokers experienceproviding sustained peak plasma levels when cravings are high and lowermaintenancelevels when cravings are lowThe SCS programmable NRT delivery device is integrated with a smartphone based smoking cessation applicationDigital Coachwhich provides behavioral support that is synchronized with the smoker s NRTcravingand smoking cycle to enablesmarttailored just in time digital coaching supportAsmartpatient compliance sensor that detects when a smoker is not wearing the device will trigger compliance alerts on SCS and a smartphone for real time compliance interventions designed to increase adherence and efficacyThe proposed SBIR Phase IIB project is predicated on a recently concluded $M Fast Track SBIR GrantRCAawarded by the National Cancer InstituteentitledSmartStopProgrammable Transdermal Nicotine Replacement Therapyand will provide funds for CTI to finalize the designed formanufacture SCS prototypecomplete FDA validationand conduct an FDA indicated definitive double blind fully poweredntwo arm randomized controlled trialRCTof smoking cessation efficacy comparing SCSprogrammable NRT Device dispensing replacement nicotineDigital Coachwith SCS Placeboprogrammable NRT Device without replacement nicotineDigital CoachThe end goal is to show SCS functionality and superiormonth quit rate efficacy over placeboCTI believes that SCS s combination ofsmartNRTsmartbehavioral supportand compliance monitoring to increase adherence will more than triple the efficacy of existing NRT productsCTI has successfully raised over $M in private funding to date in pursuit of this important public health goal