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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 is a Phase 3 study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07148206
The ClinicalTrials.gov registry entry for NCT07148206 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dronabinol Capsules is the first listed.
NCT07148206 reports 0 study locations.
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.
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