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Cannabidiol in Youth Alcohol Use Disorder

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05317546
Collaborator
(none)
35
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief 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, 35 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cannabidiol, Then Placebo

Drug: Cannabidiol
In counterbalanced order, 35 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by a 13-day washout period.
Other Names:
  • Placebo

    		•
    Experimental: Placebo, Then Cannabidiol

    Drug: Cannabidiol
    In counterbalanced order, 35 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by a 13-day washout period.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glutamate [Changes 3 hours after administration of 600mg CBD vs. placebo]

      Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy

    2. GABA [Changes 3 hours after administration of 600mg CBD vs. placebo]

      GABA level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy

    3. Alcohol cue reactivity neural activation [Changes 3 hours after administration of 600mg CBD vs. placebo]

      Blood oxygen level dependent (BOLD) signal during alcohol cue reactivity in reward and salience brain regions

    4. Alcohol cue reactivity (lab-based paradigm) [Changes 3 hours after administration of 600mg CBD vs. placebo]

      In vivo response to olfactory alcohol cues measured via heart rate

    5. Alcohol cue reactivity (lab-based paradigm) [Changes 3 hours after administration of 600mg CBD vs. placebo]

      In vivo response to olfactory alcohol cues measured via salivation

    6. Alcohol cue reactivity (lab-based paradigm) [Changes 3 hours after administration of 600mg CBD vs. placebo]

      In vivo response to olfactory alcohol cues measured via subjective ratings

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lindsay Squeglia, Associate Professor, Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT05317546
    Other Study ID Numbers:
    • Pro00119770
    First Posted:
    Apr 8, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alcoholism
    Alcohol Drinking
    Cannabidiol

    Study Results

    No Results Posted as of Aug 25, 2022