Actively Recruiting
Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain
Led by Yale University · Updated on 2026-04-14
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
V
VA Connecticut Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the dose-dependent safety and immediate effects of Cannabidiol CBD on pain and opioid craving in outpatients who have opioid use disorder OUD and are receiving medication-assisted treatment with methadone or buprenorphine. This randomized, placebo-controlled, crossover study involves adults aged 18 to 70 with chronic non-cancer pain lasting at least six months. The study aims to understand how different doses of CBD affect opioid-related outcomes and pain in this population. Participants will attend five visits over about four weeks one screening session and four experimental sessions where they receive oral doses of CBD 400 mg, 800 mg, 1200 mg or a placebo beta carotene solution. Each dose is given before their daily methadone or buprenorphine dose to ensure low opioid blood levels. The study medication order is randomized and spaced by at least 72 hours to prevent carryover effects. During each experimental session, participants will undergo multiple assessments including pain sensitivity tests, opioid craving scales, withdrawal symptom evaluations, mood questionnaires, and cognitive performance tests. Blood samples will be taken at screening and after the final dose to measure drug levels. Safety is closely monitored through a systematic assessment of side effects, and a follow-up phone call occurs one week after the last dose to check on participants well-being.
CONDITIONS
Brief Title
Cannabidiol in Opioid Use Disorder and Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 70 years old
- Diagnosed with opioid use disorder and currently enrolled in methadone or buprenorphine maintenance treatment
- Experiencing chronic non-cancer pain (grade II high-intensity) for 6 months or longer
- Able to provide informed consent in English
- On stable opioid maintenance treatment doses for at least four weeks
- No other substance use disorders except opioid or tobacco use disorders in the past 12 months
- No medical problems that would prevent participation as judged by the principal investigator
- For women, not pregnant or breastfeeding and using acceptable birth control methods; for men, using acceptable birth control methods
You will not qualify if you...
- Major unstable psychiatric disorders such as severe depression or active suicidal thoughts
- Recent major psychosocial stressors within 6 weeks before enrollment
- Methadone dose under 30 mg or over 150 mg/day
- Buprenorphine dose over 24 mg per day
- Recent inpatient psychiatric treatment within 60 days before enrollment
- Current use of THC or CBD products or positive cannabinoid test above allowed levels
- Use of psychoactive drugs affecting pain unless on stable doses for at least three months
- Regular use of benzodiazepines, other prescription opioids, or platelet inhibitors
- Current weight less than 60 kg
- Allergy to sesame seed oil
- Serious medical or neurological illness interfering with participation
- Elevated liver enzymes 2 times above normal limits or higher
- Contraindications for cold exposure such as Raynaud's phenomenon or hypertension
- Unable to abstain from cannabinoids as required by study procedures
- Dosing schedules incompatible with study visits as determined by the principal investigator
- Participants who have not passed screening requirements for cannabinoid use after allowed abstinence
Research Team
J
Joao De Aquino, M.D.
J
Julia Meyerovich, M.S.
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