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OpenTrials
Active, Not Recruiting

NCT Number: NCT05870111

Citicoline in Youth Alcohol Use Disorder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

16 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

Age 16 to 22.

Call study team for additional screening and information.

Treatment and study plan

Citicoline (cytidine diphosphate-choline)

Drug

2000mg/day citicoline, administered orally, for 4 weeks

Placebo oral capsule

Drug

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

Primary outcomes

  1. Peripheral Cytokine: IL-1B

    Time frame: 4 weeks of treatment

    Peripheral cytokine (IL-1B) to measure neuroinflammation.

  2. Peripheral Cytokine: IL-6

    Time frame: 4 weeks of treatment

    Peripheral cytokine (IL-6) to measure neuroinflammation.

  3. Peripheral Cytokine: TNFα

    Time frame: 4 weeks of treatment

    Peripheral cytokine (TNFα) to measure neuroinflammation.

  4. Brain Metabolite: N-acetyl-aspartate

    Time frame: 4 weeks of treatment

    Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.

  5. Brain Metabolite: Choline

    Time frame: 4 weeks of treatment

    Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.

  6. Neurocognition: Behavioral impulsivity

    Time frame: 4 weeks of treatment

    Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).

  7. Neurocognition: Cognitive Flexibility and Attention

    Time frame: 4 weeks of treatment

    Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.

  8. Neurocognition: Inhibitory Control and Attention

    Time frame: 4 weeks of treatment

    Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
May 23, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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