Actively Recruiting
A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
Led by University of Colorado, Denver · Updated on 2026-05-01
200
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of hemp-derived cannabidiol (CBD) in young adults aged 18 to 25 who regularly use cannabis but are not seeking treatment. The study focuses on the potential harm-reducing properties of CBD on cannabis use disorder (CUD) symptoms, mood, cognitive function, and psychotic experiences. This randomized, placebo-controlled trial uses a naturalistic approach where participants continue using their preferred cannabis products while being monitored. Participants will be randomly assigned to receive either 400 mg of broad-spectrum CBD or an inactive placebo, taken orally twice daily with food, over an 8-week period. The study includes two groups based on the type of cannabis product used: flower or concentrates. Researchers will assess both longer-term effects over 8 weeks and acute effects at specific intervals using a mobile lab setting. During the study, participants will undergo blood testing to measure THC and other cannabinoids, complete mood and cognitive assessments, and report on cannabis use and symptoms. Evaluations occur at baseline, 4 weeks, 8 weeks, and a follow-up at 12 weeks to monitor persistence of effects. The study aims to track changes in cannabis self-administration, symptoms of CUD, mental health, and cognitive function while ensuring participants maintain their usual cannabis use patterns.
CONDITIONS
Brief Title
A Study of Cannabidiol in Young Adult Cannabis Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 25
- Use cannabis flower or concentrates at least five days per week for the past year
- Not currently seeking to reduce or stop cannabis use
- Have at least two symptoms of cannabis use disorder based on DSM-5 criteria
You will not qualify if you...
- Use of illicit substances other than alcohol, nicotine, or cannabis in the past 60 days
- Alcohol use on three or more days per week or more than three drinks per drinking day in the past 60 days
- Daily nicotine use
- Diagnosis of psychotic disorders, bipolar disorder, major depression with suicidal ideation, or history of treatment for these
- Current cardiovascular or respiratory disease
- Use of psychotropic or hepatotoxic medications
- Use of anti-epileptic drugs or medications interacting with Epidiolex
- Use of strong or moderate CYP3A4 or CYP2C19 inhibitors or inducers
- History or current liver disease indicated by abnormal liver tests
- Pregnancy, lactation, or unwillingness to use birth control if of childbearing potential
- Current risk of suicidality as assessed during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants take either 400 mg of broad spectrum cannabidiol (bsCBD) or a placebo by mouth with food twice daily for 8 weeks.
Baseline and follow-up visits at 4 and 8 weeks
Duration - 4 weeks
Participants are observed for 4 weeks after treatment to assess lasting effects of the intervention.
1 visit at 12 weeks (4 weeks post-treatment)
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
C
Christian J Hopfer, MD
K
Kristen M Raymond, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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