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RECRUITING
NCT06940674
PHASE3

Adjunctive Cannabidiol for Recovery From Opioid Study

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Official title: Adjunctive Cannabidiol for Recovery From Opioid Study (ACROS)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-06-13

Completion Date

2027-08-15

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DRUG

Cannabidiol

1 capsule CBD 200mg

DRUG

Placebo

Bovine Gel Placebo capsule

Locations (2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

CODA Treatment Recovery

Portland, Oregon, United States