RECRUITING

Cannabidiol in Opioid Use Disorder and Chronic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-12-08
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04587791

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
  2. * Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
  3. * Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months 49
  4. * Capable of providing informed consent in English.
  5. * Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
  6. * Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
  7. * No current medical problems deemed contraindicated for participation by principal investigator.
  8. * For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
  1. * Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
  2. * Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
  3. * Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
  4. * A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.
  5. * Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
  6. * Current weight of less of 60 kg.

Contacts and Locations

Study Contact

Joao De Aquino, M.D.
CONTACT
203-5711
joao.dequino@yale.edu
Julia Meyerovich, M.S.
CONTACT
203-932-5711
julia.meyerovich@yale.edu

Principal Investigator

Joao De Aquino, M.D.
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Yale University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-08
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2021-12-08
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • Methadone
  • Buprenorphine
  • Cannabidiol
  • Pain

Additional Relevant MeSH Terms

  • Chronic Pain
  • Opioid Use Disorder