drugset / Trial / NCT05317546

Cannabidiol in Youth Alcohol Use Disorder

NCT05317546 ↗

Phase 2 Completed 36 enrolled Medical University of South Carolina
RandomizedCrossoverQuadruple-blindTreatment

Summary

The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 50 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.

Timeline

Start
2022-10-01
Primary completion
2024-06-25
Completion
2024-06-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Cannabidiol (600mg) vs Placebo; p = 0.33; Mixed Models Analysis NCT05317546 ↗

registry analysis (superiority test); Cannabidiol (600mg) vs Placebo; p = 0.75; Mixed Models Analysis NCT05317546 ↗

registry analysis (superiority test); Cannabidiol (600mg) vs Placebo; p >0.05; Mixed Models Analysis NCT05317546 ↗

registry analysis (superiority test); Cannabidiol (600mg) vs Placebo; p = 0.82; Mixed Models Analysis NCT05317546 ↗

registry analysis (superiority test); Cannabidiol (600mg) vs Placebo; p = 0.21; Mixed Models Analysis NCT05317546 ↗

paper There were no effects of acute CBD administration, compared to placebo, on any outcomes of interest. PMID 40500407 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 600 mg —