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Evaluating Buspirone to Treat Opioid Withdrawal
Sponsor: Johns Hopkins University
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.
Official title: Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-12-15
Completion Date
2027-03-31
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
Buspirone
Buspirone administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Lofexidine
Lofexidine administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Placebo
Participants administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Locations (1)
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States