drugset / Trial / NCT04995029
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine. The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.
Timeline
- Start
- 2021-10-26
- Primary completion
- 2024-06-26
- Completion
- 2024-06-26
Publications
- Results Shiwach R, Le Foll B, Alho H, Dunn KE, Strafford S, Zhao Y, Dobbins RL. Comparison of Extended-Release Buprenorphine Doses for Treating High-Risk Opioid Use: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548043. doi: 10.1001/jamanetworkopen.2025.48043.
- Results Shiwach R, Le Foll B, Alho H, Dunn KE, Strafford S, Zhao Y, Dobbins RL. Rapid vs Standard Induction to Injectable Extended-Release Buprenorphine: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537319. doi: 10.1001/jamanetworkopen.2025.37319.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 4 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 100 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 300 mg | Other |