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Dronabinol and Epidiolex for Opioid Use Disorder

This study is for people with Opioid Use Disorder (OUD) who have recently started buprenorphine treatment. It aims to see if combining two FDA-approved cannabis-related medications, Dronabinol (a synthetic form of THC) and Epidiolex (CBD), can help you stay in buprenorphine treatment and reduce opioid use. You might be able to join if you are 18 or older, speak English or Spanish, have an OUD diagnosis, started buprenorphine within the last 21 days, and recently tested positive for opioids or have withdrawal symptoms. The main goal is to see how many people stay in OUD treatment for about 12 weeks after starting the study medications. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It will test Dronabinol and Epidiolex against placebo versions of these drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, retention in OUD treatment, is measured at approximately 12 weeks following the start of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07148206

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

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Montefiore Medical Center
~40 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Dronabinol CapsulesEpidiolex 100 mg/mL Oral SolutionPlacebo DronabinolPlacebo Epidiolex

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention in OUD Treatment
Measured over ~12 weeks following initiation of intervention

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Deepika Slawek, MD, MPH, MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Deepika Slawek, MD, MPH, MS
[email protected]
718-920-3786
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Retention in OUD Treatment~12 weeks following initiation of intervention

    Retention in OUD Treatment will be assessed as a dichotomous measure and will be based on the number of participants maintaining both an active buprenorphine prescription AND urine toxicology positive for buprenorphine at 12 weeks. The number/percentage of participants will be summarized by study arm.