Evaluating Buspirone to Treat Opioid Withdrawal

• Status: Not yet recruiting
• Trial end date: 2027-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Buspirone; Lofexidine

Criteria

Inclusion Criteria:

• Aged 18-75

• Opioid positive urine sample

• Current moderate-severe opioid use disorder with evidence of physical dependence

• Interested in undergoing opioid detoxification

Exclusion Criteria:

• Being pregnant or breastfeeding

• Enrolled in methadone or buprenorphine maintenance treatment

• Allergic to study medication or taking medications that are contraindicated with study medication (e.g., CYP3A4 inhibitors or inducers and/or monoamine oxidase (MAO) inhibitors)

• Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in protection of human subjects form).

• Hypotension and/or prolonged QTc interval