Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS)

Keywords Opioid use disorder; Medication treatment; Buprenorphine; Naltrexone; Injection; Criminal justice Highlights * Multisite RCT of monthly extended-release buprenorphine vs. naltrexone in criminal justice settings * Open-label, multisite, pragmatic, comparative effectiveness RCT design * Primary outcome of retention on OUD medication treatment * Funded and conducted under the National Institute on Drug Abuse's Justice and Community Opioid Innovation Network Abstract The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.