NCT06107062

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Hemp-derived Cannabidiol for the Treatment of Cannabis Use Disorder: A Double-blind Placebo-controlled Randomized Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

As cannabis legalization continues to spread across the United States, average Δ9-tetrahydrocannabinol (THC) concentrations in recreational products have significantly increased, with THC levels as high as 90-95%. The investigators' preliminary data suggest that concentrate use elicits blood THC levels more than twice as high as cannabis flower use, and that concentrate use is associated with greater withdrawal, tolerance, and Cannabis Use Disorder (CUD), prompting concern about the risks of these high potency products in relation to problem use and CUD. No prior study has evaluated effective treatments to reduce cannabis use in this high risk group. Several previous studies have found that the non-intoxicating cannabinoid cannabidiol (CBD), which may antagonize the effects of THC on CB1 and CB2 receptors, reduces cannabis use and CUD-related symptoms, such as affective disturbance and withdrawal. Results of these studies are promising, but limited to synthetic or isolated forms of CBD that are not widely available. There have been no tests of the hemp-derived CBD that is widely available without a prescription across the U.S. Importantly, hemp-derived CBD comes in two forms, one with a small amount of THC (7.8mg (3.4mg BID) THC, full spectrum; fsCBD) and one without THC (0% THC; broad spectrum; bsCBD). It is possible that a small amount of THC may confer additional benefits with respect to withdrawal and related affective disturbance, and in turn be beneficial for reducing THC use overall. Consistent with this hypothesis, pilot data from the investigators' lab suggest that CBD, that also contains low levels of THC, reduces THC drug reward, withdrawal, anxiety, and overall THC use in heavy concentrate users, supporting the potential for hemp-derived CBD to reduce THC use and mitigate withdrawal in this high risk group. However, no placebo-controlled trial has been conducted comparing hemp-derived CBD with and without THC on reducing THC use. This study is a placebo-controlled RCT comparing the effects of hemp-derived CBD (fsCBD vs. bsCBD vs. placebo) on reducing THC use in concentrate users with CUD. 150 adult treatment-seeking concentrate users with DSM5 CUD will be recruited to complete an eight-week protocol. Participants will be randomly assigned to take 400 mg of either hemp-derived bsCBD (contains no THC), hemp-derived fsCBD (contains low levels of THC), or matched placebo daily for eight weeks. All participants will receive a five-session empirically supported psychological intervention to support cannabis use reduction during the trial. Participants will be assessed for changes in THC use \[self-reported mg of THC used and levels of THC's metabolite 11-nor-9-carboxy-Δ9-THC (THC-COOH)\] and CUD symptoms, as well as levels of CBD and CBD's metabolite, 7-Carboxy-Cannabidiol (CBD-COOH) to monitor medication adherence. Primary outcomes include reduction in THC exposure \[via self-reported amount used and urine THC-COOH (standardized for creatinine)\], CUD symptoms, and withdrawal symptoms, including affective, physiological, and physical symptom facets, across the 8-week study.

Conditions

• Cannabis Use Disorder

Interventions

Type	Name	Description
DRUG	Cannabidiol - fsCBD	Full-spectrum (i.e., fsCBD, 7.8mg THC (3.4mg BID)), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used.
DRUG	Placebo	Placebo arm
DRUG	Cannabidiol - bsCBD	Broad-spectrum (i.e., bsCBD, 0% THC), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used

Timeline

• Start date: 2024-05-16
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2023-10-30
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study