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

Brief description of study

This study seeks to meaningfully address the U.S. opioid epidemic by comparing the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiority, head-to-head study design will allow providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of XR-B (and XR-NTX) as potentially useful re-entry treatment option. Considering the majority of opioid users leaving jail or prison will inevitably return to their homes and communities untreated and prone to relapse, we believe findings from with important implications for limiting the greater public safety and societal costs of heroin, fentanyl, and prescription opioid addictions. Comparing retention-in-study-medication treatment, we hypothesize XR-B is non-inferior to XR-NTX.

Clinical Study Identifier: s19-01450
ClinicalTrials.gov Identifier: NCT04219540
Principal Investigator: Joshua D Lee.

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