Cannabidiol in Youth Alcohol Use Disorder

Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Cannabidiol

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Age 16 to 22. Does or does not drink alcohol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cannabidiol, Then Placebo	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.; Other Names: Placebo
Experimental: Placebo, Then Cannabidiol	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.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of Glx (i.e., Glutamate + Glutamine)	Using magnetic resonance spectroscopy and a within-subjects design, we measured Concentrations of Glx (i.e., glutamate + glutamine) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of Glx are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" glutamate levels when comparing cannabidiol to placebo.	Changes 3 hours after administration of 600mg CBD vs. placebo
GABA+	Using magnetic resonance spectroscopy and a within-subjects design, we measured GABA+ (GABA plus macromolecules) levels in the anterior cingulate cortex in adolescents during cannabidiol (600mg) or placebo administration. Values provided are absolute values (mmol/kg) measured 3 hours after medication administration. Due to complexities of this method, "normal" levels of GABA are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" GABA levels when comparing cannabidiol to placebo.	Changes 3 hours after administration of 600mg CBD vs. placebo
Alcohol Cue Reactivity Neural Activation	Assessing the change in neural reactivity to alcohol cues after each round of medication: Cannabidiol vs. placebo. Cue reactivity is a type of learned response which is observed in individuals who use substances (e.g., alcohol) and involves significant physiological reactions to presentations of substance-related stimuli (i.e., alcohol images) in comparison to neutral images (e.g., non-alcoholic beverages ) measured by BOLD (Blood Oxygen Level-Dependent response). ROIs were (left and right hemisphere): amygdala, caudate, insula, nucleus accumbens, and putamen. The mean Z-statistic within each ROI mask is reported. A Z-score of 0 represents the population mean (e.g., no activation), where higher absolute Z-scores indicate greater evidence of activation (positive or negative) in the ROI compared to baseline. Z-scores do not have inherent clinical thresholds. Higher Z-scores generally reflect stronger task-related BOLD signal changes.	Changes 3 hours after administration of 600mg CBD vs. placebo
Heart Rate Variability	All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. During the task, electrocardiogram data were collected and used to create the heart rate variability (HRV) outcome related to the Sympathetic: Vagal ratio, which is the ratio of low-frequency to high-frequency power, derived from spectral HRV analysis. Higher values suggest increased sympathetic activity or reduced vagal activity.	Changes 2 hours after administration of 600mg CBD vs. placebo
PhenX Toolkit Alcohol Urges Questionnaire	All participants underwent an in vivo, olfactory alcohol cue exposure procedure. Participants smelled water followed by the participant's preferred beverage containing alcohol and apple juice in a counterbalanced order for three minutes each, with a three-minute rest period in between each liquid. The contents were poured into a cup in the participant's presence. After each beverage exposure, self-reported alcohol craving was collected via the PhenX Toolkit Alcohol Urges Questionnaire (AUQ). The AUQ consists of eight statements about the participant's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The participant was asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree" with a scare range of 8 to 56 where higher scores represent higher alcohol craving.	Changes 2 hours after administration of 600mg CBD vs. placebo

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: Pro00119770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No