Cannabidiol and Cannabis Concentrate Users
ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25-60
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
Age 25-60.
Regular use (at least 4 times per week) of cannabis concentrates for the last year.
Not currently seeking to cut down or stop cannabis use.
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.
Disqualifiers
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.
Use of CBD-containing products other than cannabis concentrates in the past 90 days.
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 each study visit.
Daily nicotine use.
Trial design
Treatments tested in this trial
- Broad Spectrum Cannabidiol (bsCBD) 400 mg
- Broad Spectrum Cannabidiol (bsCBD) 200 mg
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov