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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Buspirone, a drug called Lofexidine, and others for people with anxiety, opioid craving, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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