Assessing the Feasibility, Usability and Acceptability of the MySafeRx Platform among Individuals in Outpatient Buprenorphine Treatment: Lessons Learned from a Pilot Randomized Controlled Trial

Background: Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment. Methods: In this multi-site randomized controlled trial, MySafeRx provided coaching and supervised self -administration of B/N by mobile recovery coaches (MRCs) via videoconference. Referred adults (ages 18-65) with OUD were randomized to 1) 42-days of adjunctive MySafeRx treatment ( n = 13) or 2) a standard care control group ( n = 14).Results: The randomized sample was 63% female and 100% White. Twelve of 13 MySafeRx participants completed at least one MRC session. The mean system usability score reported by MySafeRx participants was 78.4 ( n = 12). Participants indicated they would recommend MySafeRx to a friend (mean = 4.1 of 5), and that the dispenser (4.1 of 5) and videoconferencing (4.2 of 5) were easy to use. The MRC component had the highest acceptability (4.4 of 5). MRCs observed B/N self-administration for an average of 64.3% of the required study days (men: 68.9%; women: 57.9%). On average, men ( n = 4) met with MRCs on 32 +/- 14 days versus 47 +/- 6 days for women ( n = 8). Exploratory analyses did not show significant differences between intervention and control groups.Conclusions: Despite the small sample, this study supports usability and acceptability of MySafeRx. Increased adherence monitoring, even with remote coaching had limited appeal, which impacted feasibility due to slow recruitment, especially as community prescribing with relaxed monitoring requirements became more widespread.