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NCT05317546 Clinical Trial

Cannabidiol in Youth Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:
Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05317546
Other study ID # Pro00119770
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2022
Est. completion date July 2024

Study information
Verified date May 2024
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 22 Years
Eligibility Age 16 to 22. Does or does not drink alcohol.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabidiol
In counterbalanced order, 50 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by an approximate 18-day washout period.

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glutamate Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy Changes 3 hours after administration of 600mg CBD vs. placebo
Primary GABA GABA level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy Changes 3 hours after administration of 600mg CBD vs. placebo
Primary Alcohol cue reactivity neural activation Blood oxygen level dependent (BOLD) signal during alcohol cue reactivity in reward and salience brain regions Changes 3 hours after administration of 600mg CBD vs. placebo
Primary Alcohol cue reactivity (lab-based paradigm) In vivo response to olfactory alcohol cues measured via heart rate Changes 3 hours after administration of 600mg CBD vs. placebo
Primary Alcohol cue reactivity (lab-based paradigm) In vivo response to olfactory alcohol cues measured via salivation Changes 3 hours after administration of 600mg CBD vs. placebo
Primary Alcohol cue reactivity (lab-based paradigm) In vivo response to olfactory alcohol cues measured via subjective ratings Changes 3 hours after administration of 600mg CBD vs. placebo
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