drugset / Trial / NCT04219540
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Naltrexone | Small molecule | 380 mg | Intramuscular |