Actively Recruiting
Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study
Led by University of Colorado, Denver · Updated on 2026-05-01
120
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 plant-derived cannabidiol (CBD) on adults who regularly use cannabis concentrates but are not trying to reduce or stop their use. This randomized, placebo-controlled, dose-ranging trial aims to understand if CBD can reduce cannabis concentrate use, the subjective effects of cannabis, or cannabis craving over a four-week period. The study includes 120 frequent concentrate users who will participate in sessions conducted in a mobile laboratory. Participants will be randomly assigned to take either 200 mg or 400 mg of broad-spectrum CBD or a placebo daily for four weeks. Medication is taken orally with food twice a day, morning and evening. During the study, participants will complete three mobile lab sessions where cannabis use is monitored, blood samples are collected to measure THC and CBD levels, and subjective effects and craving are assessed. These sessions occur at the start, two weeks, and four weeks into the treatment. Throughout the study, researchers will measure changes in THC blood levels, cannabis use amounts, subjective intoxication, psychotomimetic symptoms, anxiety, negative feelings, and craving. Participants will provide blood samples before and after cannabis use in the mobile lab, and complete a cannabis cue reactivity test at two weeks. The total study duration for each participant is four weeks, during which safety and study adherence are closely monitored.
CONDITIONS
Brief Title
Cannabidiol and Cannabis Concentrate Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 to 60 years
- Regular use of cannabis concentrates at least 4 times per week for the past year
- Not currently seeking to reduce or stop cannabis use
- At least one episode of 3 consecutive days of cannabis abstinence without severe withdrawal symptoms in the last 90 days
- At least two symptoms of DSM-5 cannabis use disorder
You will not qualify if you...
- Use of any illicit substance other than 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
- Daily nicotine use
- Diagnosed psychotic disorder, bipolar disorder, or 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 medications or medications with major interactions with Epidiolex, or history of seizures
- Use of strong or moderate CYP3A4 or CYP2C19 inhibitors or inducers
- Current or past liver disease or elevated liver enzymes
- For females, pregnancy, lactation, or unwillingness to use approved birth control during the study
- Current suicidality risk as evaluated 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.
1 visit (in-person) for screening and enrollment
Duration - 4 weeks
Participants take daily doses of either 200 mg or 400 mg of plant-derived cannabidiol (CBD) or a placebo for four weeks while continuing their usual cannabis concentrate use. They complete three sessions in a mobile pharmacology laboratory to measure THC blood levels, subjective effects, and cannabis cue reactivity.
3 sessions in a mobile laboratory during the 4-week period
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Joseph P Schacht, PhD
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
3
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