Actively Recruiting
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
Eligibility Criteria
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.
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
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Trial Site Locations
Total: 1 location
1
University of Colorado Boulder
Boulder, Colorado, United States, 80301
Actively Recruiting
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
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