Citicoline in Youth Alcohol Use Disorder

May 6, 2026 updated by: Lindsay Squeglia, Medical University of South Carolina

Neurobehavioral and Immune Effects of 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion:

Age 16 to 22.

Call study team for additional screening and information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Citicoline
2000mg/day citicoline for 4 weeks, administered orally
Drug: Citicoline (cytidine diphosphate-choline)
2000mg/day citicoline, administered orally, for 4 weeks
Placebo Comparator: Placebo
placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally
Drug: Placebo oral capsule
placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral Cytokine: IL-1B
Time Frame: 4 weeks of treatment
Peripheral cytokine (IL-1B) to measure neuroinflammation.
4 weeks of treatment
Peripheral Cytokine: IL-6
Time Frame: 4 weeks of treatment
Peripheral cytokine (IL-6) to measure neuroinflammation.
4 weeks of treatment
Peripheral Cytokine: TNFα
Time Frame: 4 weeks of treatment
Peripheral cytokine (TNFα) to measure neuroinflammation.
4 weeks of treatment
Brain Metabolite: N-acetyl-aspartate
Time Frame: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
4 weeks of treatment
Brain Metabolite: Choline
Time Frame: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
4 weeks of treatment
Neurocognition: Behavioral impulsivity
Time Frame: 4 weeks of treatment
Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
4 weeks of treatment
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.
4 weeks of treatment
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.
4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

April 29, 2026

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00128800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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