The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder - ABSTRACT Although buprenorphine is a first-line intervention for Opioid Use Disorder (OUD), maintaining adherence to and retention in treatment is a significant challenge. A substantial portion of patients receiving buprenorphine discontinue treatment prematurely and/or return to illicit opioid use placing them at increased risk for overdose and death. Converging lines of evidence implicate negative affect, sleep deficiency and anhedonia as important risk factors that are associated with increased drug craving and a reoccurrence of opioid use. In turn, greater craving, and subsequent opioid use, are posited to be mechanisms underlying buprenorphine discontinuation. There is a critical need to develop innovative, scalable, solutions that modify and address these risk factors to support retention in live saving medications such as buprenorphine. The Vira Healthcare Platform is a digitally enhanced behavior change technology that has primarily been used in the management of mental health symptoms. It consists of a patient smartphone application that utilizes mobile sensing to garner insight about patterns of behavior as well as provide tailored just-in-time interventions to support behavior change. It is accompanied by an associated practitioner portal which allows clinicians or coaches to schedule customized notifications with skills, tips, and tools to support patients. The platform utilizes well-established principles from evidence-based therapy (Behavioral Activation) to provide users with the insights to sustain wellbeing and better manage opioid-related risk factors. The overarching objective of this proposal is to modify and extend the Vira Platform, augmented by coaching support from certified peer recovery support specialists (PRSS), to improve patient outcomes for OUD by delivering a digital therapeutic that integrates sensors to provide just-in-time interventions to address risk factors associated with poor treatment response – negative affect, sleep deficiency, and anhedonia. Specifically, this proposal seeks to obtain FDA authorization for the Vira Platform as a prescription digital therapeutic intended to extend the efficacy of buprenorphine. The study will be accomplished through two primary aims: (1) UG3 - using a user-centered design, adapt and refine the Vira Platform to increase relevance and usability for individuals with OUD and conduct a pilot feasibility trial; and (2) UH3 – conduct a pragmatic 2-arm randomized clinical trial among 340 patients with OUD, engaged in outpatient buprenorphine care, to evaluate the effectiveness of the Vira Platform plus treatment-as-usual (TAU), relative to TAU alone, in terms of retention in buprenorphine (primary endpoint), engagement in substance use treatment (secondary endpoint), and opioid use, craving, negative affect, sleep, anhedonia, wellbeing / quality of life, and incidence of adverse events (secondary outcomes). Go/No-Go criteria to advance from the UG3 to UH3 phase include: a) complete feasibility trial by successfully enrolling proposed sample size and b) file Q-submission/receive FDA feedback. If successful, this study will demonstrate the efficacy and safety of a simple, scalable, intervention that may easily augment standard OUD care through a prescription digital therapeutic.
