Clinical Trial

Adjunctive Cannabidiol for Recovery From Opioid Study

Study acronym: ACROS
Recruiting Phase 3
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-15; most recent amendment 2025-12-04.
Status change: Not Yet Recruiting → Recruiting 2025-06-13
Trial Details
NCT Number NCT06940674
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute on Drug Abuse (NIDA), International Center for Health Outcomes and Innovation Research, Brains Bioceutical
Conditions Opioid Use Disorder (OUD)
Enrollment 450 participants
Start Date 2025-06-13
Primary Completion 2027-07-15 (estimated)
Study Completion 2027-08-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-11