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NCT06940674 · ClinicalTrials.gov registry record · Phase 3
Adjunctive Cannabidiol for Recovery From Opioid Study
A Phase 3 study of Opioid Use Disorder (OUD), sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 2
- Study locations
NCT06940674: Recruiting Phase 3 study of Opioid Use Disorder (OUD), sponsored by Icahn School of Medicine at Mount Sinai.
NCT06940674 is a Phase 3 study of Opioid Use Disorder (OUD) that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 450 participants, above the 253-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (78% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06940674, a Phase 3 study of Opioid Use Disorder (OUD), is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 2
- Study locations
Study Summary
The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.
Primary Outcome
Percentage of study participants with negative urine toxicology for illicit opioid use over the course of 24 weeks.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol
Study Locations (2)
New York
- Icahn School of Medicine at Mount Sinai - New York
Oregon
- CODA Treatment Recovery - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2027-08-15 |
| Phase | Phase 3 |
What NCT06940674 shows while recruiting
NCT06940674 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 253-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (78% higher).
The record links to 1 condition, with Opioid Use Disorder (OUD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06940674 reports a single indexed study location in New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT06940674 about?
NCT06940674 is a clinical study titled "Adjunctive Cannabidiol for Recovery From Opioid Study". The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects ...
What is the current status of trial NCT06940674?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2025-06-13. Estimated completion is 2027-08-15.
What conditions does trial NCT06940674 study?
This clinical trial studies the following conditions: Opioid Use Disorder (OUD).
What interventions are being tested in trial NCT06940674?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT06940674?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06940674 being conducted?
This trial has 2 study locations across New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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