Actively Recruiting
Adjunctive Cannabidiol for Recovery From Opioid Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-11
450
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Adjunctive Cannabidiol for Recovery From Opioid Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals between 18 and 65 years old.
- Ability to understand and give informed consent.
- Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with opioid agonist treatment.
- Receiving methadone maintenance treatment at a dose of at least 10mg/day and positive urine tests for methadone and EDDP.
- Receiving buprenorphine maintenance treatment at a dose of at least 2mg/day and positive urine test for buprenorphine.
- On methadone or buprenorphine maintenance therapy for at least 14 days prior to consent.
You will not qualify if you...
- Non-English speaking individuals.
- Psychiatric conditions making participation unsafe or preventing adherence, including high suicide or homicide risk, active psychosis, or uncontrolled bipolar disorder.
- Severe substance use disorder other than opioid or nicotine/tobacco in the past 3 months.
- Signs of acute drug intoxication at study site arrival.
- Medical or psychiatric contraindications to CBD or its ingredients.
- Signs of acute opioid withdrawal symptoms at screening.
- Medical conditions making participation unsafe or preventing adherence, including low kidney function, prolonged QTc interval, or elevated liver enzymes.
- Participation in another pharmacotherapeutic trial in the past 3 months.
- Use or planned use of medications or supplements that interact with CBD within 14 days before consent or during the 24-week treatment.
- For women, pregnancy or breastfeeding.
- Not using an appropriate method of contraception.
- Court-mandated attendance at treatment centers.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
2
CODA Treatment Recovery
Portland, Oregon, United States, 97214
Actively Recruiting
Research Team
Z
Zoe Spieler
CONTACT
J
Jonathan Hupf
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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