Citicoline in Youth Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05870111
• Other study ID #: Pro00128800
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: February 2029

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: Cori Herring, BS
• Phone: 843-792-8207
• Email: herrinco[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 2029
• Est. primary completion date: February 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

Inclusion:

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

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