Citicoline in Youth Alcohol Use Disorder

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Citicoline (cytidine diphosphate-choline); Drug: Placebo oral capsule

• Registration Number: NCT05870111
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-23
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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: 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: Inhibitory Control and Attention	4 weeks of treatment	Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention.
Brain Metabolite: N-acetyl-aspartate	4 weeks of treatment	Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Neurocognition: Cognitive Flexibility and Attention	4 weeks of treatment	Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States