Cannabidiol in Opioid Use Disorder and Chronic Pain

Description

This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 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.

Conditions

Chronic Pain, Opioid Use Disorder

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Study Overview

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Study Details

Study overview

This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 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.

Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain

Cannabidiol in Opioid Use Disorder and Chronic Pain

Condition
Chronic Pain
Intervention / Treatment

-

Contacts and Locations

West Haven

Department of Veterans Affairs Hospital, West Haven, Connecticut, United States, 06516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Joao De Aquino, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2025-04-30