Real-world evidence for a prescription digital therapeutic to treat opioid use disorder

Abstract Objectives To evaluate patient engagement and usage of a prescription digital therapeutic (PDT) and associated outcomes of opioid use and treatment retention in a large real-world dataset of patients with opioid use disorder (OUD) treated with buprenorphine medication for opioid use disorder (MOUD). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials (RCTs), and authorized by the U.S. Food and Drug Administration (FDA) to treat disease with approved directions for use (label). Methods A real-world observational evaluation of an all-comer population of patients who redeemed a 12-week prescription for the reSET-O PDT. Engagement and therapeutic use data were collected and analysed on a population level. Substance use was evaluated as a composite of self-reports recorded with reSET-O and urine drug screens (UDS). Results Data from 3144 individuals with OUD were evaluated. 45.5% were between ages 30 and 39 years. 80% completed at least 8 of the 67 possible therapeutic modules, 66% completed half of all modules, and 49% completed all modules. Abstinence during the last 4 weeks of treatment was calculated with two imputation methodologies: 66% abstinent using “missing data excluded (patients with no data as positive)”, and 91% abstinent with “missing data removed (patients with no data excluded)”. 91% of patients met the responder definition of ≥80% of self-report or UDS negative. 74.2% of patients were retained through the last 4 weeks of treatment. Subgroup analysis of patients using reSET-O appropriately (4 or more modules per week for the first 4 weeks) showed 88.1% abstinence using “missing data excluded (patients with no data as positive)”, and retention at weeks 9–12 of 85.8%. Conclusions Results demonstrate that reSET-O is readily and broadly used by patients with OUD and that high real-world engagement with the therapeutic is positively associated with abstinence and retention in treatment. ReSET-O is a potentially valuable adjunct to buprenorphine MOUD therapy for patients with OUD.

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