A Digital Therapeutic Mobile App, ReSET-O, as Adjunct to Medication Treatment for Opioid Use Disorder: A Randomized Clinical Trial at an Opioid Treatment Program.

Abstract

This study evaluated ReSET-O, a mobile app derived from the previously studied, computer-based therapeutic education system (TES), delivering cognitive behavioral therapy (CBT) lessons plus contingency management, rewarding CBT lesson completion and drug-negative urines, as an intervention to improve medication retention for opioid use disorder (MOUD). A 24-week randomized controlled trial was conducted in an outpatient opioid treatment program where patients starting methadone or buprenorphine treatment were randomized to treatment as usual (TAU) or TAU plus the app. The primary outcome, medication retention, was defined as at most a 28-day gap in the first 24 weeks of medication dispensation or prescription. Secondary outcomes examined urine drug tests, mood assessments, app engagement, and app feedback. Fifty-two participants were randomized to TAU (29 on buprenorphine, 23 on methadone) and 48 (28 on buprenorphine, 20 on methadone) to TAU+ the app. 51.9% (n=27) on TAU met 24-week MOUD medication retention, compared with 70.8% (n=34) on TAU + the app (OR: 2.28; 95% CI: [0.99, 5.24]); P =0.053; Rate difference: 18.9% (95% CI: [0.2, 37.6]). No significant differences resulted between groups in urine toxicology or mood outcomes. Adherence to the app varied, with over half of participants (53%, 25/48) completing <10 out of 48 CBT therapy lessons. ReSET-O had no significant impact on MOUD retention. The study did not meet its recruitment target, was underpowered, and adherence to the app was poor. Further research is indicated on apps delivering CBT plus contingency management for improving MOUD outcomes, including improving adherence to app use.