Evaluating Buspirone to Treat Opioid Withdrawal

Description

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

Opioid Use Disorder, Opioid Withdrawal, Opioid Craving, Anxiety

Study Overview

Study Details

Study overview

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.

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Evaluating Buspirone to Treat Opioid Withdrawal

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Cecilia Bergeria, Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2027-03-31