Using buspirone to help with opioid withdrawal
Official title: Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal
Run by University of Maryland, Baltimore · NCT05511909 · Data updated 2026-11-12
This study is testing if the medication buspirone can help people with opioid use disorder feel less withdrawal symptoms and cravings while they are tapering off opioids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | December 15, 2022 |
| Main results expected | January 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT05511909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 with moderate to severe opioid use disorder who are interested in undergoing opioid detoxification.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or currently enrolled in methadone or buprenorphine maintenance treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II clinical trial aims to evaluate the effectiveness of buspirone in reducing opioid withdrawal symptoms and cravings in individuals with opioid use disorder (OUD). Participants will undergo a standardized stepwise taper of opioids over a 10 to 12-day residential period, during which they will be randomized into three groups: one receiving buspirone, one receiving lofexidine, and one receiving a placebo. The study will assess treatment retention and relapse rates, providing a comprehensive evaluation of buspirone's potential benefits for those undergoing opioid detoxification. The trial is designed to fill a gap in research regarding buspirone's efficacy in a diverse population of individuals with OUD.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing opioid withdrawal and cravings, potentially improving recovery outcomes for patients with opioid use disorder.
How similar studies have gone: Previous smaller studies have shown promising results for buspirone in treating opioid withdrawal, but this is the first rigorously designed trial to evaluate its efficacy in a larger and more representative sample.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Kahlert Institute for Addictino Medicin
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Cecilia Bergeria, Ph.D. — Johns Hopkins University
- Study coordinator: Cecilia Bergeria, Ph.D.
- Email: cberge21@jhmi.edu
- Phone: 410-550-1979
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.