Longitudinal Outpatient Treatment for Cannabis Use Disorder

Part of paid clinical trials in Boulder, Colorado.

Sponsor
University of Colorado, Boulder
Study ID
NCT06107062
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol - fsCBD — DRUG
    Full-spectrum (i.e., fsCBD, 7.8mg THC (3.4mg BID)), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used.
  • Placebo — DRUG
    Placebo arm
  • Cannabidiol - bsCBD — DRUG
    Broad-spectrum (i.e., bsCBD, 0% THC), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used

Study Details

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Key Dates

Start date
May 16, 2024
Status verified
Jun 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 400mg Full Spectrum Cannabidiol (fsCBD)
  • Experimental: 400mg Broad Spectrum Cannabidiol (bsCBD)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Difference in cannabis use [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado BoulderBoulderColorado80301
Devon Rapken
[email protected]

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By research site
University of Colorado Boulder· Boulder, CO

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