NCT05870111

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started Oct 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2024Feb 2029

First Submitted

Initial submission to the registry

May 4, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Expected
Last Updated

June 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 4, 2023

Last Update Submit

June 10, 2026

Conditions

Alcohol Use Disorder

Keywords

Citicoline

Outcome Measures

Primary Outcomes (8)

  • Peripheral Cytokine: IL-1B

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

    4 weeks of treatment

  • Peripheral Cytokine: IL-6

    Peripheral cytokine (IL-6) to measure neuroinflammation.

    4 weeks of treatment

  • Peripheral Cytokine: TNFα

    Peripheral cytokine (TNFα) to measure neuroinflammation.

    4 weeks of treatment

  • Brain Metabolite: N-acetyl-aspartate

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

    4 weeks of treatment

  • Brain Metabolite: Choline

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

    4 weeks of treatment

  • Neurocognition: Behavioral impulsivity

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

    4 weeks of treatment

  • Neurocognition: Cognitive Flexibility and Attention

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

    4 weeks of treatment

  • Neurocognition: Inhibitory Control and Attention

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

    4 weeks of treatment

Study Arms (2)

Citicoline

EXPERIMENTAL

2000mg/day citicoline for 4 weeks, administered orally

Drug: Citicoline (cytidine diphosphate-choline)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Placebo oral capsuleDRUG

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

Placebo
Citicoline (cytidine diphosphate-choline)DRUG

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

Citicoline

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 23, 2023

Study Start

October 1, 2024

Primary Completion

April 29, 2026

Study Completion (Estimated)

February 1, 2029

Last Updated

June 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)