Opioid Use DisorderOpioid WithdrawalOpioid CravingAnxiety
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of Maryland, Baltimore · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 75 who have a dependence on opioids and want to detoxify. Participants will stay in a residential facility for 10 to 12 days to gradually reduce their opioid use while being closely monitored.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have a positive urine test for opioids.
I have moderate to severe opioid use disorder.
I am interested in detoxifying from opioids.
You may not be able to join if
I am pregnant or breastfeeding.
I am currently receiving methadone or buprenorphine treatment.
I am allergic to the study medication.
I have a serious mental health or physical problem that would affect my participation.
I have low blood pressure.
I have a prolonged QTc interval.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 mainte…
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
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