A Study of Cannabidiol in Young Adult Cannabis Users (NCT06569394) | Clinical Trial Compass
RecruitingPhase 2
A Study of Cannabidiol in Young Adult Cannabis Users
United States200 participantsStarted 2024-12-09
Plain-language summary
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.
Who can participate
Age range18 Years – 25 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
✓. Ages 18-25
✓. Must have used cannabis flower or concentrates at least five days per week for the past year.
✓. Currently not seeking to cut down or stop cannabis use
✓. 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.
✕. 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, major depression with suicidal ideation, or a history of treatment for these disorders.
What they're measuring
1
Difference in blood THC-COOH levels
Timeframe: 8 weeks
2
Difference in blood THC levels
Timeframe: 1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
✕. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
✕. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medication.
✕. Current 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.
✕. Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include protease inhibitors, macrolide antibiotics \[e.g., erythromycin\], azole antifungals \[e.g., ketoconazole\], verapamil, and grapefruit juice).