Pear Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: NIDA

Description

PROJECT SUMMARY ABSTRACT Opioid Use DisorderOUDis a key driver of the current opioid epidemic in the United StatesNearlyof individuals with OUD do not receive treatmentBuprenorphine Medication Assisted TreatmentMATis an effective form of care for OUDBuprenorphine ameliorates craving and withdrawaland reduces illicit opioid usemortalityand problems associated with drug useHoweveradoption of buprenorphine in clinical practice is not yet commensurate with patient needIn additionpoor induction experiences and medication nonadherence are associated with high likelihood of treatment drop out and relapseThe perceived need for observed buprenorphine induction contributes to providersunwillingness to prescribe buprenorphine to patientsthereby limiting patientsaccess to standard of careMaximizing the efficacy and accessibility of existing pharmacotherapeutics is critical to helping individuals with OUD receive optimal and necessary careThusan urgent need exists to improve medication adherence and provide strategies to alleviate potential barriers to implementation of buprenorphine in clinical practicee ginduction supportThe premise of this proposal is to develop a state of the artdigital therapeutic thateffectively promotes buprenorphine adherence by providing contingency management rewards and educational content to reinforce the importance of medication in recovery andeffectively assists home induction with a new self monitoring support tool designed for patientsThis solutionnamed reSET Owill be integrated with Pear TherapeuticsreSET Oan FDA market authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for OUDPhase I of this proposal will focus on developing and testing a functional reSET Oprototype to establish feasibilitye gacceptabilityin patients with OUDPhase II efforts will expandrefine and validate the reSET OinterventionPhase IIa will use iterative patient feedback to expand the medication adherence based contingency management system and refine buprenorphine related content and featuresA small randomized controlled trial comparing reSET Oto reSET O will evaluate efficacye ginduction success and medication adherencesafetyand patient engagement in Phase IIbreSET Owill provide an innovative approach for OUD treatment that addresses shortcomings in the current standard of care such as buprenorphine uptake and adherenceA widely accessible digital therapeutic which effectively supports induction and adherence to buprenorphineand is integrated within a validated behavioral therapyis likely to promote recovery by facilitating treatment retentionrelapse preventionand better clinical outcomesGiven the number of individuals in need of MAT and the impact medication nonadherence has on patient outcomesthere is a substantial need for reSET OPROJECT NARRATIVE Buprenorphine Medication Assisted Treatment can effectively treat Opioid Use DisorderOUDbut medication nonadherence limits its effectiveness and is associated with poor patient outcomes such as relapse to substance useThis project will develop and test a mobile application that supports home induction of buprenorphine treatment and integrates rewards to reinforce buprenorphine adherencewithin a validated behavioral therapy for the treatment of OUDIf the mobile application is shown to be safefeasibleand an effective method of improving medication initiation and adherenceit would represent a major advance in the field of OUD treatmentproviding a digital therapeutic with high potential to promote recovery by facilitating better clinical outcomes for patients