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Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial
Sponsor: Montefiore Medical Center
Summary
The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \[THC\]) and Epidiolex (cannabidiol \[CBD\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-05
Completion Date
2027-12
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Dronabinol Capsules
Dronabinol is a synthetic form of THC. Dronabinol is eliminated in a biphasic manner, with an initial half-life of 25-36 hours.
Epidiolex 100 mg/mL Oral Solution
Epidiolex is an oral solution (100 mg/mL) which rapidly appears in plasma, reaches peak plasma concentration in 3-4 hours and has a half-life of 18-32 hours.
Placebo Dronabinol
Placebo capsules
Placebo Epidiolex
Placebo oral solution
Locations (1)
Montefiore Health System (Montefiore) Buprenorphine Treatment Network
The Bronx, New York, United States