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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

Tracking Information
First Submitted Date  ICMJE March 21, 2022
First Posted Date  ICMJE April 8, 2022
Last Update Posted Date November 15, 2022
Actual Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2022)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol in Youth Alcohol Use Disorder
Official Title  ICMJE Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Cannabidiol, Then Placebo
    Intervention: Drug: Cannabidiol
  • Experimental: Placebo, Then Cannabidiol
    Intervention: Drug: Cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2022)		 35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Age 16 to 22. Does or does not drink alcohol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lindsay Squeglia, PhD 8437925451 squegli@musc.edu
Contact: Cori Herring, BS 843-792-8207 herrinco@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05317546
Other Study ID Numbers  ICMJE Pro00119770
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lindsay Squeglia, Medical University of South Carolina
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP