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NCT07148206 · ClinicalTrials.gov registry record · Phase 3
Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial
A Phase 3 study, sponsored by Montefiore Medical Center.
- Not yet
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT07148206: Clinical Trial Phase 3 study, sponsored by Montefiore Medical Center.
NCT07148206 is a Phase 3 study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07148206, a Phase 3 study, has not yet begun recruiting, sponsored by Montefiore Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Dronabinol Capsules
- DRUG Epidiolex 100 mg/mL Oral Solution
- OTHER Placebo Dronabinol
- OTHER Placebo Epidiolex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-10 |
| Est. Completion | 2028-05 |
| Phase | Phase 3 |
What is known before NCT07148206 opens enrollment
NCT07148206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Dronabinol Capsules is the first listed.
NCT07148206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07148206 about?
NCT07148206 is a clinical study titled "Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial". 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 co...
What is the current status of trial NCT07148206?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2026-10. Estimated completion is 2028-05.
What interventions are being tested in trial NCT07148206?
The interventions under investigation include: Dronabinol Capsules (DRUG), Epidiolex 100 mg/mL Oral Solution (DRUG), Placebo Dronabinol (OTHER), Placebo Epidiolex (OTHER).
Who is sponsoring clinical trial NCT07148206?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07148206's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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