Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain
Yale University
Summary
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.
Description
Thirty-four male and female (ages 18-70) participants with comorbid opioid use disorder (OUD) and non-cancer chronic pain for at least 6 months, currently receiving methadone (n= 22) or buprenorphine (n= 12), will be enrolled. Across four test sessions, prior to their daily methadone or buprenorphine dose, and thus at trough plasma levels of opioid, participants will receive oral CBD (400 mg, 800 mg, 1200 mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes. Pain sensitivity will be measured using Quantitative Sensory Testing (QST), the Pai…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females, Veterans and non-Veterans, aged between 18 and 70 years old. * Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment. * Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer pain for ≥ 6 months. * Capable of providing informed consent in English. * Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer. * Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months. * No current medical pro…
Interventions
- Drug400 mg Cannabidiol
Participants will receive 400 mg CBD
- Drug800 mg Cannabidiol
Participants will receive 800 mg CBD
- Drug1200 mg Cannabidiol
Participants will receive 1200 mg CBD
- DrugBeta carotene oral solution without CBD
Participants will receive beta carotene oral solution without CBD (placebo)
Location
- Department of Veterans Affairs HospitalWest Haven, Connecticut