Citicoline in Youth Alcohol Use Disorder

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05870111

Enrollment

Registered

2023-05-23

Start date

2024-10-01

Completion date

2029-02-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Citicoline

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.

Interventions

DRUGCiticoline (cytidine diphosphate-choline)

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

DRUGPlacebo oral capsule

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 22 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Peripheral Cytokine: IL-1B	4 weeks of treatment	Peripheral cytokine (IL-1B) to measure neuroinflammation.
Peripheral Cytokine: IL-6	4 weeks of treatment	Peripheral cytokine (IL-6) to measure neuroinflammation.
Peripheral Cytokine: TNFα	4 weeks of treatment	Peripheral cytokine (TNFα) to measure neuroinflammation.
Brain Metabolite: N-acetyl-aspartate	4 weeks of treatment	Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Brain Metabolite: Choline	4 weeks of treatment	Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
Neurocognition: Behavioral impulsivity	4 weeks of treatment	Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
Neurocognition: Cognitive Flexibility and Attention	4 weeks of treatment	Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
Neurocognition: Inhibitory Control and Attention	4 weeks of treatment	Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026