Patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder: protocol for a randomized controlled open-label, decentralized trial (Preprint)

BACKGROUND Prescription digital therapeutics (PDTs) are software-based disease treatments that are regulated by the U.S. Food and Drug Administration (FDA). The reSET-O® PDT was FDA-authorized in 2018 and delivers behavioral treatment for individuals receiving buprenorphine for opioid use disorder (OUD). Although reSET-O improves outcomes for individuals with OUD, most of the therapeutic content is delivered as narrative text. PEAR-008 is an investigational device based on reSET-O that uses an interactive, game-based platform to deliver similar therapeutic content designed to enhance patient engagement, which may further improve treatment outcomes. OBJECTIVE The primary objective of this trial is to compare PEAR-008 to reSET-O to investigate how participants interact with the PDT’s changed delivery format. Secondary objectives include evaluating treatment success, symptoms of co-occurring mental health disorders, recovery capital, and skill development. METHODS A decentralized, randomized controlled trial (RCT) design will be utilized to compare PEAR-008 with reSET-O and evaluate differences in patient engagement with the therapeutics. The study population will consist of approximately 130 individuals with OUD (based on DSM-5 criteria) who have recently started buprenorphine for OUD (MOUD) treatment. Participants will be virtually recruited and randomly assigned to receive either PEAR-008 or reSET-O. All study sessions will be virtual and the duration of the study is 12 weeks. The primary outcome measure of engagement is operationalized as the number of active sessions per week with PEAR-008 vs. reSET-O. (An active session is any session that contains some active participation in the application such as navigating to a different screen, engaging with a learning module, or responding to a notification.) The hypothesis is that PEAR-008 will have significantly greater participant engagement compared to reSET-O. RESULTS Due to the COVID-19 pandemic, this study was re-designed using a de-centralized model as it was not possible to conduct medication initiation and study visits in person, as initially intended. Digital treatments like PDTs lend themselves well to a virtual study design. Furthermore, shifting to virtual recruitment has the added benefit of allowing a broader pool of study participants than is typically recruited by the participating study sites. This trial is actively enrolling. CONCLUSIONS This randomized controlled trial will use a decentralized study model and investigate if changing the delivery format and enhancing the content of a PDT for OUD will affect how participants use and interact with the PDT. The study design may serve as a useful model for conducting decentralized studies in this patient population.