Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

Summary

This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.

Timeline

Start

2024-10-14

Primary completion

2025-11-04

Completion

2026-01-14

Publications

• Mooney LJ, Saxon AJ, Black M, Ober AJ, Lewis M, Walker R, McCormack J, Scheele C, Hser YI. Randomized controlled pilot trial of extended-release buprenorphine vs. sublingual buprenorphine-naloxone in rural settings (RXR): Study rationale and design. Contemp Clin Trials. 2026 May;164:108288. doi: 10.1016/j.cct.2026.108288. Epub 2026 Mar 16.

Drugs

Indications