Evaluating Buspirone to Treat Opioid Withdrawal
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
Qualifiers
Aged 18-75
Opioid positive urine sample
Current moderate-severe opioid use disorder with evidence of physical dependence
Interested in undergoing opioid detoxification
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Buspirone
- Lofexidine
- Placebo
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov