Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial (NCT07148206)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (10 items).
Location: Montefiore Health System (Montefiore) Buprenorphine Treatment Network — The Bronx, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Montefiore Health System (Montefiore) Buprenorphine Treatment Network — The Bronx, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.