A Phase 2 interventional study of Broad Spectrum Cannabidiol (bsCBD) 400 mg and Placebo in Cannabis Use Disorder, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Other
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.
Emerging adults have the highest prevalence of cannabis use and CUD of any age group. Despite high rates of use and CUD, treatment seeking is relatively uncommon among emerging adults. Those who use cannabis are less confident in their ability to abstain and show higher rates of ambivalence regarding the goal of abstinence than those who use other drugs. Thus, emerging adult cannabis users may be more receptive to non-abstinence or harm reduction approaches. The overarching aim of this proposal is to assess the effects of hemp-derived CBD in emerging adults on harms associated with cannabis use including subjective intoxication, affect and mood, psychotic experiences, and cognitive functioning, as well as to examine whether CBD supplementation reduces self-administration of THC and symptoms of CUD. The investigators propose a study design with high external validity and experimental controls to study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo, consistent with the preliminary studies that have approved US Food and Drug Administration (FDA) Investigation New Drug (IND 153535 and 157515).
The specific aims are to:
Aim 1: Test whether assignment to hemp-derived CBD, relative to placebo, over 8 weeks is associated with a) reduced self-administration of THC, b) a reduction in CUD symptoms, c) lower levels of anxiety, depression, d) better cognitive function, and e) higher anandamide (AEA) levels. Hypothesis: Compared to baseline, the CBD group will demonstrate reduced THC administration, fewer CUD symptoms, lower levels of anxiety and depression, and better cognitive functioning at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist. Assignment to CBD will be correlated with higher AEA levels.
Aim 2: Test whether assignment to hemp-derived CBD, relative to placebo, reduces acute effects of cannabis administration on: a) subjective drug effects, b) cognitive function, and c) mood and psychotic symptoms. Hypothesis: Compared to cannabis self-administration at baseline (without CBD), the CBD group will demonstrate lower subjective drug effects (mood elevation, anxiety), fewer psychotic symptoms, and better cognitive functioning after cannabis self-administration at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist.
Aim 3: Test whether cannabis product type (flower vs. concentrates) moderates the association between CBD assignment and a) cannabis use, b) mood and anxiety, and c) cognitive functioning in both longer-term (aim 1) and acute (aim 2) effects. Hypothesis: CBD effects will be greater among those who use concentrates compared to those who use flower products for both longer-term and acute effects.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
bsCBD in a 400 mg dose will be used as described in the study arms.
Drug: Broad Spectrum Cannabidiol (bsCBD) 400 mg
A medically inert placebo medication will be used as described in the study arms.
Drug: Placebo
Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
Difference in blood THC-COOH levels
THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion.
Time frame: 8 weeks
Difference in blood THC levels
THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion.
Time frame: 1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
Difference in cannabis use
Total number of days of cannabis use during the 8-week medication period as reported on daily diaries.
Time frame: 8 Weeks
Adverse effects
Adverse effects reported at Week 4 and Week 8 of medication ingestion
Time frame: 8 weeks
Difference in blood CBD levels
CBD levels in blood samples collected at Week 4 and Week 8 of medication ingestion
Time frame: 8 weeks
Plan to share: No — Data will be shared through a NIDA P50 data sharing resource.
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University of Colorado, Denver