Cannabidiol and Cannabis Concentrate Users
NCT Number: NCT06575751
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cannabis Use Disorder
Interventions: DRUG: Broad Spectrum Cannabidiol (bsCBD) 400 mg|DRUG: Broad Spectrum Cannabidiol (bsCBD) 200 mg|DRUG: Placebo
Sponsor: University of Colorado, Denver
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2028-06-30
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States

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.

Primary Outcome Measures: Difference in blood 11-Nor-9-carboxy-THC (THC-COOH) levels, THC-COOH levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion, 4 weeks|Difference in blood delta-9-tetrahydrocannabinol (THC) levels, THC levels in blood samples collected before and after cannabis use at baseline and at Week 4 of medication ingestion, 4 weeks|Difference in cannabis use, Total number of days of cannabis use during the 4-week medication period as reported on daily diaries, 4 weeks
Secondary Outcome Measures: Difference in cannabis-induced intoxication, Drug Effects Questionnaire score following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 5, higher scores = greater intoxication), 4 weeks|Difference in cannabis-induced subjective effects, Addiction Research Center Inventory Marijuana score following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 12, higher scores = greater subjective effects), 4 weeks|Difference in cannabis-induced psychotomimetic symptoms, Psychotomimetic States Inventory paranoia and cognitive disorganization item scores following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 54, higher scores = greater psychotomimetic symptoms), 4 weeks|Difference in cannabis-induced anxiety and negative affect, Profile of Mood States short form tension, vigor, and elation subscale item scores following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 60, higher scores = greater anxiety and negative affect), 4 weeks|Difference in cannabis craving, Marijuana Craving Questionnaire-Short Form score before and after the cannabis cue reactivity procedure at Week 2 of medication ingestion (minimum = 12, maximum = 84, higher scores = greater craving), 2 weeks
Other Outcome Measures: Difference in blood cannabidiol (CBD) levels, CBD levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion, 4 weeks|Adverse effects, Adverse effects reported at baseline and Week 4 of medication ingestion, 4 weeks