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Search / Trial NCT05511909

Evaluating Buspirone to Treat Opioid Withdrawal

Launched by JOHNS HOPKINS UNIVERSITY · Aug 19, 2022

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called buspirone to help people who are experiencing withdrawal symptoms from opioids, which are strong pain medications that can be addictive. The trial will include individuals aged 18 to 75 who have a moderate to severe opioid use disorder and can provide a positive urine sample for opioids. Participants will be going through a carefully controlled process to reduce their opioid use gradually, known as a taper, over a period of 10 to 12 days. After this tapering period, they will have the option to start long-term treatment with other medications that help with opioid dependence.

Eligible participants will not be pregnant or breastfeeding, and they should not be currently receiving other specific treatments for opioid addiction like methadone or buprenorphine. During the trial, participants will be randomly assigned to receive either the buspirone medication or a placebo (a harmless pill with no active medication) without knowing which one they are receiving. This helps researchers understand how effective buspirone is compared to no treatment. It’s an important step in finding better ways to support individuals facing opioid withdrawal and cravings. If you or someone you know is considering joining this study, it could be a valuable opportunity to receive help in overcoming opioid dependence.

Gender

ALL

Eligibility criteria

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

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Patients applied

CS

KO

2 patients applied

Trial Officials

Cecilia Bergeria, Ph.D.

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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