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RECRUITING
NCT06107062
PHASE2

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Sponsor: University of Colorado, Boulder

View on ClinicalTrials.gov

Summary

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.

Official title: Hemp-derived Cannabidiol for the Treatment of Cannabis Use Disorder: A Double-blind Placebo-controlled Randomized Trial

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2024-05-16

Completion Date

2029-03-31

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

DRUG

Cannabidiol - fsCBD

Full-spectrum (i.e., fsCBD, 7.8mg THC (3.4mg BID)), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used.

DRUG

Placebo

Placebo arm

DRUG

Cannabidiol - bsCBD

Broad-spectrum (i.e., bsCBD, 0% THC), plant-derived CBD capsules produced by Ecofibre/Ananda Hemp will be used

Locations (1)

University of Colorado Boulder

Boulder, Colorado, United States