Overview

Evaluating Buspirone to Treat Opioid Withdrawal

Status:
Not yet recruiting
Trial end date:
2027-03-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Treatments:
Buspirone
Lofexidine
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