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Adjunctive Cannabidiol for Recovery From Opioid Study

NCT06940674 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-12-11

No results posted yet for this 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.

Conditions

  • Opioid Use Disorder (OUD)

Interventions

DRUG

Cannabidiol

1 capsule CBD 200mg

DRUG

Placebo

Bovine Gel Placebo capsule

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • International Center for Health Outcomes and Innovation Research

    collaborator OTHER

  • Brains Bioceutical

    collaborator UNKNOWN

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Yasmin Hurd, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2027-07-15
Completion
2027-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940674 on ClinicalTrials.gov