Evaluating Buspirone to Treat Opioid Withdrawal
Recruiting · NCT05511909 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Maryland, Baltimore
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Kahlert Institute for Addictino Medicin - Baltimore, Maryland, United States