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.
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
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
Parallel
Dronabinol Capsules
DrugDronabinol 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
DrugEpidiolex 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
Other interventionPlacebo capsules
Placebo Epidiolex
Other interventionPlacebo oral solution
Retention in OUD Treatment
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.
Retention in OUD Treatment
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.
Opioid Use - Self Reported
Self-reported opioid use will be assessed using the Timeline Follow-back (TLFB) calendar-based research tool. Using the TLFB methodology, participants will be provided with a calendar and asked to record, using a binary "Yes" or "No" response, whether opioid was used during each day over the prior 30-day period. Participants will be guided by a trained assessor during this process to help facilitate recall. If a participant's most recent study visit was within 30 days, then opioid use will be limited to the period of time since the last study visit. The number of days using opioids over the prior 30-day period will be summarized by study arm.
Opioid Use - Urine Toxicology
Opioid use will also be assessed using a urine toxicology immunoassay. Unobserved urine sample collection will be conducted at defined visits and samples will be analyzed to detect for the presence opioids and their metabolites. Results above the laboratory threshold for opiates will be reported as Either "Positive" or "Negative" and summarized by study arm at each timepoint.
Opioid Use Disorder Symptoms - Subjective Opiate Withdrawal Scale
Opioid Use Disorder Symptoms will be assessed using the Subjective Opiate Withdrawal Scale (SOWS). The SOWS is a 16-item clinician administered scale designed to reproducibly rate the severity of opiate withdrawal symptoms. Participants rate each symptom on a 5-point scale ranging from 0 ("Not at all") to 4 ("Extremely") based on the intensity they are experiencing at the moment, yielding an overall possible range from 0-64, wherein higher scores are associated with more severe withdrawal symptoms. Specific scoring guideline categories include 1-10 = mild withdrawal; 11-20 = moderate withdrawal; 21-30+ = severe withdrawal. Mean scores will be summarized by study arm at each timepoint using basic descriptive statistics.
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Montefiore Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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