drugset / Trial / NCT04219540

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

NCT04219540

RandomizedParallel-groupOpen-labelTreatment

Summary

This study seeks to compare 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 offer 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 and relapse prevention treatment options. It is hypothesized that XR-B is non-inferior to XR-NTX when comparing retention-in-study-medication treatment options.

Timeline

Start
2021-01-07
Primary completion
2024-08-01
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 100 mg Subcutaneous
Subject Naltrexone Small molecule 380 mg Intramuscular

Indications