Opioid Use Disorder Clinical Trials

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

Who is this study for? Adult patients with chronic pain and opiate dependence
What treatments are being studied? Cannabidiol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Department of Veterans Affairs Hospital
RECRUITING
West Haven
Contact Information
Primary
Joao De Aquino, M.D.
joao.deaquinolima@yale.edu
203-932-5711
Backup
Julia Meyerovich, M.S.
julia.meyerovich@yale.edu
203-932-5711
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 34
Treatments
Active_comparator: CBD 400 mg
CBD 400 mg
Active_comparator: CBD 800 mg
CBD 800mg
Active_comparator: CBD 1200 mg
CBD 1200 mg
Placebo_comparator: Beta carotene oral solution
Beta carotene oral solution without CBD
Authors
Joao De'Aquino, Mehmet Sofuoglu
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), VA Connecticut Healthcare System
Leads: Yale University

This content was sourced from clinicaltrials.gov