Citicoline in Youth Alcohol Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Citicoline (cytidine diphosphate-choline)
* Drug: Placebo oral capsule


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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Citicoline