Abstract/Summary Opioid Use Disorder (OUD) is a serious public health concern that affected 2.5 million Americans and was responsible for a record number of overdose deaths in 2014. Remarkably, 80-90% of individuals with OUD do not receive treatment, even though OUD can be successfully treated when cognitive behavioral therapy is combined with buprenorphine pharmacotherapy. A major barrier to receiving care is limited access to providers. For those who do seek treatment, high rates of attrition and lack of medication adherence limit the effectiveness of care. There is an urgent need for treatment solutions that address these problems. The goal of Pear Therapeutics’ Fast-Track proposal is to develop a widely accessible, game-based behavioral therapy for OUD that improves patient engagement and supports medication compliance. This solution, named Options and Outcomes (O&O), is a mobile application designed to supplement standard face-to-face OUD behavioral therapy. O&O will be modeled on Pear’s current digital intervention for Substance Use Disorder, reSET, a clinically validated digital therapy that significantly improves clinical outcomes. Although effective, reSET’s curriculum is primarily delivered using narrative text. Building a more interactive and appealing product to deliver the same educational content has the potential to increase patient engagement and enhance learning. O&O will be a role-playing game that requires active participation: patients will interact with the main characters, guiding their decision making process as they learn and deploy key concepts taught during the game. Newly developed content and features will emphasize the important role of buprenorphine in recovery and support medication adherence. This proposal is an innovative evolution from previous systems: O&O will deliver validated therapeutic content in in a unique and effective way that is not currently possible. Pear’s long term goal is to help individuals with OUD achieve lasting recovery by creating effective and accessible digital therapies. The first phase of this proposal will focus on developing and test a functional O&O prototype using proven videogame techniques to maximize patient engagement and leveraging digital capabilities to support buprenorphine adherence. Phase II efforts will expand and validate the O&O intervention. Phase IIa will use iterative patient feedback to incorporate reSET’s core curriculum into an immersive game environment that is realistic and relevant. A small randomized control trial comparing O&O to reSET will evaluate patient engagement, learning and efficacy in Phase IIb. O&O will provide an innovative approach for OUD treatment that addresses shortcomings in the current standard of care such as access, buprenorphine adherence and patient retention. O&O will be marketed to OUD treatment centers as an off-the-shelf digital application that can enhance standard therapy. Given the number of individuals in need of accessible treatment options for OUD, there is a substantial market for O&O.

Project Narrative The US is currently facing an opioid epidemic: millions of Americans are dependent on or abuse opioids, and opioid-related overdose deaths hit record levels in 2014. Although Opioid Use Disorder can be effectively treated when behavioral therapy is combined with buprenorphine pharmacotherapy, lack of medication adherence and high attrition rates for those who do seek treatment limit the effectiveness of care. To help address this crisis, Pear Therapeutics will develop and validate a mobile application that uses an interactive game environment to deliver effective behavioral therapy and support buprenorphine compliance, helping patients achieve lasting recovery by more actively engaging them in treatment.