Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75

• Opioid positive urine sample

• Current moderate-severe opioid use disorder with evidence of physical dependence

• Interested in undergoing opioid detoxification

Locations
United States
Maryland
Behavioral Pharmacology Research Unit
RECRUITING
Baltimore
Contact Information
Primary
Cecilia Bergeria, Ph.D.
cberge21@jhmi.edu
410-550-1979
Backup
Caitlyn Grubb, B.S.
cgrubb7@jhmi.edu
410-550-0490
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 100
Treatments
Experimental: opioid stepwise taper + buspirone
up to 45mg/day buspirone during the opioid stepwise taper
Active_comparator: opioid stepwise taper + lofexidine
up to 2.16mg/day lofexidine during the opioid stepwise taper
Placebo_comparator: opioid stepwise taper + placebo
placebo during the opioid stepwise taper
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov

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