Actively Recruiting

Phase 2
Age: 21Years +
All Genders
NCT06107062

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Led by University of Colorado, Boulder · Updated on 2025-06-19

165

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Boulder

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

CONDITIONS

Official Title

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Regular use (at least 4 times per week) of cannabis concentrates for at least the last year.
  • Meets DSM5 criteria for at least moderate Cannabis Use Disorder.
  • Currently seeking to cut down or stop cannabis use.
Not Eligible

You will not qualify if you...

  • Use of any substance of abuse besides alcohol, nicotine, or cannabis in the past 90 days.
  • Use of CBD-dominant products in the past 90 days or CBD blood levels at baseline of 5 ng/mL or higher.
  • Alcohol use on 3 or more days per week, or more than 3 drinks per drinking day in the past 90 days.
  • Daily nicotine use.
  • Diagnosis or history of psychotic disorder, bipolar disorder, or major depression with suicidal ideation.
  • Current cardiovascular or respiratory disease.
  • Current use of psychotropic or anti-epileptic medications that may affect CBD.
  • History or evidence of liver disease.
  • For participants assigned female at birth, pregnancy or trying to become pregnant.
  • History of seizures.
  • Current use of specific medications that interact with CBD.
  • Allergy to study medications such as hemp seed oil, hemp extract, gelatin, or glycerin.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Colorado Boulder

Boulder, Colorado, United States, 80301

Actively Recruiting

Loading map...

Research Team

J

Jonathan Lisano, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here