Buspirone for Opioid Withdrawal and Craving

This study is testing if buspirone, an FDA-approved medication, can help people with opioid use disorder (OUD) manage opioid withdrawal symptoms and cravings. You would receive either buspirone, lofexidine (another medication for withdrawal), or a placebo (an inactive substance) for about 10 days while undergoing a supervised opioid taper (gradual reduction of opioids). Researchers want to see if buspirone can reduce withdrawal symptoms, as measured by a survey called the Subjective Opiate Withdrawal Scale (SOWS), from two days before the taper until two days after. You could join if you are 18-75 years old, have moderate-to-severe OUD, and are interested in detoxification. The study aims to enroll 100 participants, but its current status is unclear.

Study design
This is a Phase II, three-group, double-blind, placebo-controlled randomized clinical trial. About 100 participants will be enrolled.
What's involved
You would stay in a clinical research unit for 10-12 days. During this time, you would receive study medication and undergo an opioid taper.
Compensation
Not stated in the trial record.
Follow-up
Your opioid withdrawal symptoms will be measured from two days before the opioid taper until two days after the taper.

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NCT05511909

Evaluating Buspirone to Treat Opioid Withdrawal

Recruiting
PHASE2Ages 18–75InterventionalTreatment
University of Maryland, Baltimore
~100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:BuspironeLofexidinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Measured over Days -2 to 8
Opioid Use Disorder
Opioid Withdrawal
Opioid Craving
Anxiety
1 sites across 1 states
Maryland1
  • Cecilia Bergeria, Ph.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)Days -2 to 8

    Opioid withdrawal severity will be measured with the Subjective Opiate Withdrawal Scale (SOWS) and will be computed as a daily peak total SOWS score for study days -2 to 8. The SOWS consists of 16 opioid withdrawal symptoms that are assessed for severity on a scale from 0-4 ("Not at all" to "Extremely"). Total scores range from 0-64 where a score between 0-10 is considered mild, between 11-20 is considered moderate, and greater than 21 is considered severe.