ACTIVE_NOT_RECRUITING

Evaluating Buspirone to Treat Opioid Withdrawal

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Quick Facts

Study Start:2022-12-15
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05511909

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-75
  2. * Opioid positive urine sample
  3. * Current moderate-severe opioid use disorder with evidence of physical dependence
  4. * Interested in undergoing opioid detoxification
  1. * Being pregnant or breastfeeding
  2. * Enrolled in methadone or buprenorphine maintenance treatment
  3. * 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)
  4. * 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).
  5. * Hypotension and/or prolonged QTc interval

Contacts and Locations

Principal Investigator

Cecilia Bergeria, Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-15
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2022-12-15
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Opioid Withdrawal
  • Opioid Craving
  • Anxiety