Actively Recruiting

Phase 2
Age: 25Years - 60Years
All Genders
NCT06575751

Cannabidiol and Cannabis Concentrate Users

Led by University of Colorado, Denver · Updated on 2026-05-01

120

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.

CONDITIONS

Official Title

Cannabidiol and Cannabis Concentrate Users

Who Can Participate

Age: 25Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 25-60.
  • Regular use (at least 4 times per week) of cannabis concentrates for the last year.
  • Not currently seeking to cut down or stop cannabis use.
  • At least one episode of 3 consecutive days of cannabis abstinence with no severe withdrawal symptoms in the last 90 days.
  • At least two symptoms of a DSM-5 cannabis use disorder.
Not Eligible

You will not qualify if you...

  • Use of any illicit substance besides alcohol, nicotine, or cannabis in the past 60 days.
  • Use of CBD-containing products other than cannabis concentrates in the past 90 days.
  • Alcohol use on 3 or more days per week, or more than 3 drinks per drinking day in the past 60 days.
  • Breath alcohol level above 0 at study visits.
  • Daily nicotine use.
  • Diagnosis or history of psychotic disorders, bipolar disorder, or major depression with suicidal ideation.
  • Current cardiovascular or respiratory disease.
  • Use of psychotropic or hepatotoxic medications.
  • Use of anti-epileptic medications or medications interacting with Epidiolex, or history of seizures.
  • Use of strong or moderate CYP3A4 or CYP2C19 inhibitors or inducers.
  • Current or past liver disease indicated by medical history or liver enzyme levels.
  • Pregnancy, trying to become pregnant, or lactating for female participants.
  • Not willing to use approved birth control if of childbearing potential.
  • Current suicidality risk as assessed during study screening.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

J

Joseph P Schacht, PhD

CONTACT

K

Kristen M Raymond, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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