Cannabidiol in Opioid Use Disorder and Chronic Pain

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 3 weeks, during which participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, Cannabidiol (CBD) will be administered, separated by at least 72 hours to limit carryover effects.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); VA Connecticut Healthcare System
• Treatments: Cannabidiol; Epidiolex

Criteria

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 musculoskeletal pain for ≥ 6 months 49

• Capable of providing informed consent in English.

• Compliant in opioid maintenance treatment and on a stable dose for two 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 problems deemed contraindicated for participation by principal investigator.

• For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.

Exclusion Criteria:

• Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.

• Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.

• Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).

• A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.

• Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).

• Current weight of less of 60 kg.