drugset / Trial / NCT06940674
Adjunctive Cannabidiol for Recovery From Opioid Study
Phase 3
Recruiting
450 enrolled
Icahn School of Medicine at Mount Sinai
Brains Bioceutical · collabInternational Center for Health Outcomes and Innovation Research · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2025-06-13
- Primary completion
- 2027-07-15
- Completion
- 2027-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 200 mg | Oral |
| Subject | Cannabidiol | Other / unclassified | 400 mg | Oral |