Cannabidiol and Cannabis Concentrate Users (NCT06575751) | Clinical Trial Compass
RecruitingPhase 2
Cannabidiol and Cannabis Concentrate Users
United States120 participantsStarted 2024-12-04
Plain-language 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.
Who can participate
Age range25 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. At least two symptoms of a DSM-5 cannabis use disorder.
Exclusion criteria
✕. 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.
✕. Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, or major depression with suicidal ideation, or has a history of treatment for these disorders.
✕
What they're measuring
1
Difference in blood 11-Nor-9-carboxy-THC (THC-COOH) levels
Timeframe: 4 weeks
2
Difference in blood delta-9-tetrahydrocannabinol (THC) levels
. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
✕. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medications.
✕. Currently use of anti-epileptic medications (e.g., clobazam, sodium valproate) or medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide) or a history of seizures.