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Cannabidiol in Youth Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT05317546
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Lindsay Squeglia, Medical University of South Carolina

Study Description
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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
Alcohol Use Disorder Drug: Cannabidiol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Cannabidiol

Arms and Interventions
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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 Name: 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 Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Glutamate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Changes 3 hours after administration of 600mg CBD vs. placebo ]
    In vivo response to olfactory alcohol cues measured via subjective ratings


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Age 16 to 22. Does or does not drink alcohol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05317546


Contacts
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Contact: Lindsay Squeglia, PhD 8437925451 squegli@musc.edu
Contact: Cori Herring, BS 843-792-8207 herrinco@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lindsay M Squeglia, PhD    843-792-5451    squegli@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
More Information
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Responsible Party: Lindsay Squeglia, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05317546    
Other Study ID Numbers: Pro00119770
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Cannabidiol
Anticonvulsants