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RecruitingPhase 2NCT05511909

Evaluating Buspirone to Treat Opioid Withdrawal

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Sponsor

University of Maryland, Baltimore

Enrollment

100 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Aged 18-75
  • Opioid positive urine sample
  • Current moderate-severe opioid use disorder with evidence of physical dependence
  • Interested in undergoing opioid detoxification

Exclusion Criteria5

  • 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

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Interventions

DRUGBuspirone

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).

DRUGLofexidine

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).

DRUGPlacebo

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)

Kahlert Institute for Addictino Medicin

Baltimore, Maryland, United States

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NCT05511909