Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study
University of Colorado, Denver
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.
Description
The overarching aim of this proposal is to combine a naturalistic cannabis administration paradigm with a placebo-controlled, dose-ranging randomized controlled trial of plant-derived cannabidiol (CBD) to evaluate CBD effects on cannabis concentrate use, subjective effects, and cannabis cue reactivity. To achieve this aim, 120 adult frequent concentrate users will be recruited to complete a four-week protocol during which they will complete three sessions in a mobile pharmacology laboratory. Up to 200 participants may be consented/enrolled to account for screen failures and attrition. In two o…
Eligibility
- Age range
- 25–60 years
- Sex
- All
- Healthy volunteers
- No
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, benzodiazepin…
Interventions
- DrugBroad Spectrum Cannabidiol (bsCBD) 400 mg
Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
- DrugBroad Spectrum Cannabidiol (bsCBD) 200 mg
Participants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
- DrugPlacebo
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
Location
- University of Colorado Anschutz Medical CampusAurora, Colorado