Cannabidiol and Cannabis Concentrate Users

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06575751
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
25 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Broad Spectrum Cannabidiol (bsCBD) 400 mg — DRUG
    Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
  • Broad Spectrum Cannabidiol (bsCBD) 200 mg — DRUG
    Participants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
  • Placebo — DRUG
    Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Broad Spectrum Cannabidiol (bsCBD) 400 mg
    bsCBD in a 400 mg dose will be used as described in the study arms.
  • Active Comparator: Broad Spectrum Cannabidiol (bsCBD) 200 mg
    bsCBD in a 200 mg dose will be used as described in the study arms.
  • Placebo Comparator: Placebo
    A medically inert placebo medication will be used as described in the study arms.

Primary Outcome Measure

Difference in blood 11-Nor-9-carboxy-THC (THC-COOH) levels [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Joseph P Schacht, PhD
[email protected]
303-724-3773
Kristen M Raymond, BA
[email protected]
303-724-3196
Joseph P Schacht, PhD (PRINCIPAL_INVESTIGATOR)
L. Cinnamon Bidwell, PhD (SUB_INVESTIGATOR)

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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