Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Opioid Use Disorder

In brief

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 facts

Study ID

NCT07148206

Run by

Montefiore Medical Center

People needed

40

Starts

2026-10-01

Expected to finish

2028-05-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fluency in English and Spanish
• The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD
• Newly initiated on buprenorphine within 21 days
• Positive urine toxicology for opioids other than buprenorphine in the past week OR opioid withdrawal symptoms in the past week based on the Clinical Opioid Withdrawal Scale (COWS) >=5
• Any cannabis use in the past at or after the age of 18 years based on self-report

You may not qualify if…

• Urine toxicology positive for cannabinoids
• Inability to provide informed consent
• Liver tests (AST or ALT) >3 times the upper limit of normal, or a history of liver disease
• Pregnancy or breast/chest feeding
• Unstable cardiac disease, history of hypotension or syncope
• Psychotic disorder, or history of suicidal behavior and/or ideation
• Progressive neurological conditions, frequent falls, or history of epileptic seizures
• Severe alcohol use disorder, benzodiazepine use disorder or stimulant use disorder
• Other serious medical conditions that would be a contraindication to THC or CBD use

Where it is running

• Montefiore Health System (Montefiore) Buprenorphine Treatment Network — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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