drugset / Trial / NCT05511909

Evaluating Buspirone to Treat Opioid Withdrawal

NCT05511909

Phase 2 Recruiting 100 enrolled University of Maryland, Baltimore
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

EvaluationDrugModalityDoseRoute
Subject Buspirone Small molecule 45 mg
Comparator Lofexidine Small molecule 2.16 mg