Status:
NOT_YET_RECRUITING
Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
OUD and opioid overdose death rates remain shockingly high in the United States fueled by high potency opioids like fentanyl. Buprenorphine is an evidence-based therapy for OUD that reduces mortality,...
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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07148206
Start Date
January 1 2026
End Date
August 1 2027
Last Update
October 8 2025
Active Locations (1)
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1
Montefiore Health System (Montefiore) Buprenorphine Treatment Network
The Bronx, New York, United States, 10467