Cannabidiol in Opioid Use Disorder and Chronic Pain

NCT ID
NCT04587791
Registry status
Recruiting
Study type
Interventional
Phase
Early Phase 1
Sponsor
Yale University
Conditions
Chronic Pain, Opioid Use Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 34 participants (Estimated).

What is being studied

  • Drug: 1200 mg Cannabidiol
  • Drug: 400 mg Cannabidiol
  • Drug: 800 mg Cannabidiol
  • Intervention: Alkenes
  • Intervention: beta Carotene
  • Drug: Beta carotene oral solution without CBD
  • Intervention: Biological Factors
  • Intervention: Cannabidiol
  • Intervention: Cannabinoids
  • Intervention: Carotenoids
  • Intervention: Cyclohexanes
  • Intervention: Cyclohexenes
  • Intervention: Cycloparaffins
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Acyclic
  • Intervention: Hydrocarbons, Alicyclic
  • Intervention: Hydrocarbons, Cyclic
  • Intervention: Organic Chemicals
  • Intervention: Pigments, Biological
  • Intervention: Polyenes
  • Intervention: Terpenes

Who may be eligible

Ages
18 Years to 70 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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 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 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. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception 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. * Methadone dose under 30 mg or over 150 mg/day. * Buprenorphine dose over 24 mg per day. * Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment). * Candidates receiving products containing either THC or CBD will be excluded. All participants will be asked to abstain from cannabinoids. Prior to receiving the study medication on the first test session, participants' cannabinoid use will be assessed using a quantitative point-of-care urine 11-nor-9-carboxy-THC concentration test with a cut-off of ≤ 50 mg/mL. If a participant tests greater than ≤50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study. * A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), gabapentinoids, tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, carbamazepine)). Only participants who are on stable doses (i.e., consistent daily administration of the medication for at least three months at the same dose following the last dose change, either increase or decrease) of these medications, and whose dosing schedules allow participation in the study visits, thus excluding instances of single-dose or temporary dosing of the medication, will be eligible as determined by principal investigator. If possible, the morning dose will be administered after the study visit. * Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor). * Current weight of less of 60 kg. * Allergy to sesame seed oil, which is an ingredient of the CBD formulation used. * Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator. * Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher. * Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Connecticut, United States: 1

Sample of listed locations

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

Study details

Start date
December 8, 2021
Primary completion date
August 31, 2026
Completion date
August 31, 2026
First posted
October 14, 2020
Collaborators
National Institute on Drug Abuse (NIDA), VA Connecticut Healthcare System

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04587791
Registry last updated
April 14, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT04587791 on ClinicalTrials.gov

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