Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05511909

Evaluating Buspirone to Treat Opioid Withdrawal

Led by University of Maryland, Baltimore · Updated on 2026-05-01

100

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluating Buspirone to Treat Opioid Withdrawal

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • Positive opioid urine test
  • Current moderate to severe opioid use disorder with physical dependence
  • Interested in undergoing opioid detoxification
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Enrolled in methadone or buprenorphine maintenance treatment
  • Allergic to study medication or taking contraindicated medications such as CYP3A4 inhibitors or MAO inhibitors
  • Significant mental health or physical disorder or life circumstance expected to interfere with participation
  • Hypotension or prolonged QTc interval

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Kahlert Institute for Addictino Medicin

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

C

Cecilia Bergeria, Ph.D.

CONTACT

C

Caitlyn Grubb, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Evaluating Buspirone to Treat Opioid Withdrawal | DecenTrialz