Home › Opioid Overdose › NCT05511909
Evaluating Buspirone to Treat Opioid Withdrawal
Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal
Who can join
Ages 18 to 75 · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Buspirone (drug)
- Lofexidine (drug)
- Placebo (drug)
Sponsor: University of Maryland, Baltimore · Participants: 100 · Started: Dec 15, 2022
Contact the study team
- Cecilia Bergeria, Ph.D. · Phone: 410-550-1979
- Caitlyn Grubb, B.S. · Phone: 410-550-0490
Official record on ClinicalTrials.gov — NCT05511909
Locations in the U.S.
| Maryland | Kahlert Institute for Addictino Medicin, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.