NCT05511909 Evaluating Buspirone to Treat Opioid Withdrawal
| NCT ID | NCT05511909 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-03-15 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Cecilia Bergeria, Ph.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05511909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05511909 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05511909 currently recruiting?
Yes, NCT05511909 is actively recruiting participants. Contact the research team at cberge21@jhmi.edu for enrollment information.
Where is the NCT05511909 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05511909 clinical trial?
NCT05511909 is sponsored by University of Maryland, Baltimore. The principal investigator is Cecilia Bergeria, Ph.D. at Johns Hopkins University. The trial plans to enroll 100 participants.