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Recruiting Phase 2 NCT06575751

NCT06575751 Cannabidiol and Cannabis Concentrate Users

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Clinical Trial Summary
NCT ID NCT06575751
Status Recruiting
Phase Phase 2
Sponsor University of Colorado, Denver
Condition Cannabis Use Disorder
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2024-12-04
Primary Completion 2028-06-30

Trial Parameters

Condition Cannabis Use Disorder
Sponsor University of Colorado, Denver
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 120
Sex ALL
Min Age 25 Years
Max Age 60 Years
Start Date 2024-12-04
Completion 2028-06-30
Interventions
Broad Spectrum Cannabidiol (bsCBD) 400 mgBroad Spectrum Cannabidiol (bsCBD) 200 mgPlacebo

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Brief Summary

This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.

Eligibility Criteria

Inclusion Criteria: 1. Age 25-60. 2. Regular use (at least 4 times per week) of cannabis concentrates for the last year. 3. Not currently seeking to cut down or stop cannabis use. 4. At least one episode of 3 consecutive days of cannabis abstinence with no experience of severe withdrawal symptoms (i.e., \>=4 DSM-5 Cannabis Withdrawal symptoms rated as "severe"), in the last 90 days. 5. At least two symptoms of a DSM-5 cannabis use disorder. Exclusion Criteria: 1. Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine, opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60 days, as indicated by self-report and urine toxicology screening at the beginning of each study visit. 2. Use of CBD-containing products other than cannabis concentrates in the past 90 days. 3. Alcohol use on 3 or more days per week, and/or \> 3 drinks per drinking day in the past 60 days. Participants must also have a breath alcohol level of 0 at the beginning of

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