Clinical trial of an innovative digital therapeutic for smoking cessation with biochemical verification

Cigarette smoking is the leading preventable cause of death in the USAlthoughout ofsmokers want to quitless thanof quit attempts remain successful one year laterSmartphone apps are a promising method to deliver behavioral interventions due to their immediate accessibilityreduced barriers to treatmentand high penetration of the target populationThe goal of this SBIR is to reduce the health impact of smoking by establishing Click TherapeuticsIncs smartphone app for smoking cessationClickotineCKTas a digital therapeutic solution to help smokers quit with lower costreduced need for healthcare accessand fewer adverse effects than current best alternativesCKT follows US Clinical Practice GuidelinesUSCPGfor smoking cessation and uses interventions supported by researchpersonalized messagingcontrolled breathingsocial engagementtreatment adherencefinancial incentivesand digital diversionsShort term quit rates observed in a pilot clinical trial of CKT compare favorably to published results of other smartphone apps for smoking cessationHoweverto date no such studies have provided biochemically verified evidence for long term quit rateswhich forms the gold standard for measuring other therapies for smokingThis project will address this gap in knowledge through blinded randomized controlled trials comparing CKT to another widely used USCPG smartphone appthe National Cancer Institute s QuitGuideThis pivotal research will feature longer term follow up and biochemical verification with feasibility established in Phase IThe results of this study will provide the rigorous clinical evidence for the efficacy and safety of CKT necessary for its successful commercialization in the digital therapeutics marketWide availability of an engaginglow cost mobile intervention to help smokers quit with reduced healthcare usage will have substantial population level impact on public health in the United States This proposal will generate rigorous clinical evidence for Clickotinean innovativelow cost smartphone app for smoking cessationSuccessful completion of the research will lead to the development of an effective treatment to reduce thedeaths per year and $billion in health care costs caused by cigarette smoking