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Cannabidiol in Opioid Use Disorder and Chronic Pain

NCT04587791 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

400 mg Cannabidiol

Participants will receive 400 mg CBD

DRUG

800 mg Cannabidiol

Participants will receive 800 mg CBD

DRUG

1200 mg Cannabidiol

Participants will receive 1200 mg CBD

DRUG

Beta carotene oral solution without CBD

Participants will receive beta carotene oral solution without CBD (placebo)

Sponsors & Collaborators

  • VA Connecticut Healthcare System

    collaborator FED

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587791 on ClinicalTrials.gov