Actively Recruiting
Cannabidiol in Opioid Use Disorder and Chronic Pain
Led by Yale University · Updated on 2026-04-14
34
Participants Needed
1
Research Sites
246 weeks
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
This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or buprenorphine. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.
CONDITIONS
Official Title
Cannabidiol in Opioid Use Disorder and Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
- Diagnosed with opioid use disorder and currently enrolled in methadone or buprenorphine maintenance treatment.
- Have chronic non-cancer pain of grade II intensity lasting 6 months or longer.
- Able to provide informed consent in English.
- Stable and compliant with opioid maintenance treatment for four weeks or longer.
- No other substance use disorders (except tobacco) within the last 12 months.
- No medical problems that would prevent participation as determined by the principal investigator.
- Women must not be pregnant or breastfeeding and must use acceptable birth control; men must use acceptable contraception.
You will not qualify if you...
- Current major unstable psychiatric disorders such as severe depression or active suicidal thoughts.
- Recent major psychosocial stressors within 6 weeks before enrollment.
- Methadone dose lower than 30 mg or higher than 150 mg per day.
- Buprenorphine dose over 24 mg per day.
- Recent inpatient psychiatric treatment within 60 days before enrollment.
- Use of THC or CBD products; inability to abstain from cannabinoids as verified by urine tests.
- Unstable use or recent changes in psychoactive medications affecting pain, unless stable 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 to cold exposure such as Raynaud's phenomenon or hypertension.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
J
Joao De Aquino, M.D.
CONTACT
J
Julia Meyerovich, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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