drugset / Trial / NCT05511909
Evaluating Buspirone to Treat Opioid Withdrawal
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-01-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buspirone | Small molecule | 45 mg | — |
| Comparator | Lofexidine | Small molecule | 2.16 mg | — |