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

NCT07148206 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2025-17060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opioid Use Disorder

Keywords

Buprenorphine; delta-9-Tetrahydrocannabinol (THC); Cannabidiol (CBD); Cannabinoids; Opioid Use; Opioid Withdrawal; Retention to Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  ~12 weeks following initiation of intervention

Secondary Outcomes (10)

• Retention in OUD Treatment

  Baseline and ~1-week, 2-weeks, 4-weeks, and 8-weeks following initiation of intervention

• Opioid Use - Self Reported

  Baseline and ~1-week, 2-weeks, 4-weeks, 8-weeks, and 12 weeks following initiation of intervention

• Opioid Use - Urine Toxicology

  Baseline and ~2-weeks, 4-weeks, 8-weeks, and 12 weeks following initiation of intervention

• Opioid Use Disorder Symptoms - Subjective Opiate Withdrawal Scale

  Baseline and ~4-weeks, 8-weeks, and 12 weeks following initiation of intervention

• Opioid Use Disorder Symptoms - Opiate Craving Scale

  Baseline and ~4-weeks, 8-weeks, and 12 weeks following initiation of intervention

Study Arms (2)

Dronabinol + Epidiolex Arm

EXPERIMENTAL

Dronabinol (THC) will be dosed every 12 hours. To limit potential adverse effects, the dose of dronabinol will be titrated up gradually over 15 days to a final daily dose of 20 mg (10 mg every 12 hours). This final dosage will be administered twice daily from Day 16 to Week 8. Epidiolex (CBD) will also be dosed every 12 hours. To limit potential adverse effects, the dose of Epidiolex will be titrated up gradually over 15 days to a final dose of 400 mg every 12 hours. Participants will start off taking 200 mg daily (100 mg every 12 hours) for 5 days, then uptitrate to 400 mg (200 mg every 12 hours) for 5 days, then uptitrate to 600 mg for 5 days (300 mg every 12 hours), and finally 800 mg from day 16 through week 8 (400 mg every 12 hours).

Drug: Dronabinol Capsules; Drug: Epidiolex 100 mg/mL Oral Solution

Placebo Arm

PLACEBO COMPARATOR

Placebo Dronabinol capsules will be labeled and identical in appearance to dronabinol capsules. They will be made of pearl capsules filled with lactose by Montefiore's Investigational Drug Pharmacy team. Placebo Epidiolex oral solution will be made up of ethanol (79.0 mg/mL), sucralose (0.5 mg/mL), strawberry flavor (0.2 mg/mL), and refined sesame oil (to a volume of 1 mL). This mixture will be identical in appearance, taste, and composition of Epidiolex, except for the active ingredient of pure CBD.

Other: Placebo Dronabinol; Other: Placebo Epidiolex

Interventions

Dronabinol Capsules DRUG

Dronabinol is a synthetic form of THC. Dronabinol is eliminated in a biphasic manner, with an initial half-life of 25-36 hours.

Also known as: Marinol

Dronabinol + Epidiolex Arm

Epidiolex 100 mg/mL Oral Solution DRUG

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.

Also known as: Cannabidiol (CBD)

Dronabinol + Epidiolex Arm

Placebo Dronabinol OTHER

Placebo capsules

Placebo Arm

Placebo Epidiolex OTHER

Placebo oral solution

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Health System (Montefiore) Buprenorphine Treatment Network

The Bronx, New York, 10467, United States

Location

Related Publications (46)

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Related Links

• Arnsten JH. Does Medical Cannabis Reduce Opioid Use in Adults With Pain
• Slawek DE. Pain, Inflammation, and Cannabis in HIV
• Withdrawal Management. In: Clinical Guidelines for Withdrawal Management and Treatment of Drug Dependence in Closed Settings. World Health Organization; 2009.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dronabinol; Cannabidiol; Solutions

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Pharmaceutical Preparations

Study Officials

• Deepika Slawek, MD, MPH, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepika Slawek, MD, MPH, MS

CONTACT

718-920-3786; dslawek@montefiore.org

Deepika Slawek

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All products will be blinded to participants and research staff except for the study statistician and partnering pharmacists. Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)