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Citicoline in Youth Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Citicoline (cytidine diphosphate-choline)
Placebo oral capsule
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Citicoline

Eligibility Criteria

16 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion: Age 16 to 22. Call study team for additional screening and information.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Citicoline

    Placebo

    Arm Description

    2000mg/day citicoline for 4 weeks, administered orally

    placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally

    Outcomes

    Primary Outcome Measures

    Peripheral Cytokine: IL-1B
    Peripheral cytokine (IL-1B) to measure neuroinflammation.
    Peripheral Cytokine: IL-6
    Peripheral cytokine (IL-6) to measure neuroinflammation.
    Peripheral Cytokine: TNFα
    Peripheral cytokine (TNFα) to measure neuroinflammation.
    Brain Metabolite: N-acetyl-aspartate
    Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
    Brain Metabolite: Choline
    Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
    Neurocognition: Behavioral impulsivity
    Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
    Neurocognition: Cognitive Flexibility and Attention
    Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
    Neurocognition: Inhibitory Control and Attention
    Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05870111
    Brief Title
    Citicoline in Youth Alcohol Use Disorder
    Official Title
    Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    February 2029 (Anticipated)
    Study Completion Date
    February 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    Citicoline

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Citicoline
    Arm Type
    Experimental
    Arm Description
    2000mg/day citicoline for 4 weeks, administered orally
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally
    Intervention Type
    Drug
    Intervention Name(s)
    Citicoline (cytidine diphosphate-choline)
    Intervention Description
    2000mg/day citicoline, administered orally, for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Intervention Description
    placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally
    Primary Outcome Measure Information:
    Title
    Peripheral Cytokine: IL-1B
    Description
    Peripheral cytokine (IL-1B) to measure neuroinflammation.
    Time Frame
    4 weeks of treatment
    Title
    Peripheral Cytokine: IL-6
    Description
    Peripheral cytokine (IL-6) to measure neuroinflammation.
    Time Frame
    4 weeks of treatment
    Title
    Peripheral Cytokine: TNFα
    Description
    Peripheral cytokine (TNFα) to measure neuroinflammation.
    Time Frame
    4 weeks of treatment
    Title
    Brain Metabolite: N-acetyl-aspartate
    Description
    Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
    Time Frame
    4 weeks of treatment
    Title
    Brain Metabolite: Choline
    Description
    Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
    Time Frame
    4 weeks of treatment
    Title
    Neurocognition: Behavioral impulsivity
    Description
    Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
    Time Frame
    4 weeks of treatment
    Title
    Neurocognition: Cognitive Flexibility and Attention
    Description
    Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
    Time Frame
    4 weeks of treatment
    Title
    Neurocognition: Inhibitory Control and Attention
    Description
    Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.
    Time Frame
    4 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion: Age 16 to 22. Call study team for additional screening and information.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cori Herring, BS
    Phone
    843-792-8207
    Email
    herrinco@musc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Citicoline in Youth Alcohol Use Disorder

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