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Evaluating Buspirone to Treat Opioid Withdrawal

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Mar 15, 2023 to Dec 15, 2022v9
  2. Re-verified, no change to tracked fieldsv8
  3. Sponsor changed: Johns Hopkins University to University of Maryland, Baltimore
    • Trial status changed: Active, Not Recruiting → Recruiting
    • Start date: Dec 15, 2022 to Mar 15, 2023
    • Study site revised
    v7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  5. 2 versions Re-verified since Dec 13, 2023, no change to tracked fieldsv4-v5
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Start date: Oct 15, 2022 to Dec 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05511909
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Opioid Use Disorder, Opioid Withdrawal, Opioid Craving, Anxiety
Related terms Anxiety Disorders, Opioid-Related Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov