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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline | Experimental | 2000mg/day citicoline for 4 weeks, administered orally |
|
| Placebo | Placebo Comparator | placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline (cytidine diphosphate-choline) | Drug | 2000mg/day citicoline, administered orally, for 4 weeks |
|
| 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 |
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Inclusion:
Age 16 to 22.
Call study team for additional screening and information.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2026 | Jun 10, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Placebo oral capsule | Drug | placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally |
|
Inhibitory control and attention will be measured via the NIH Toolbox Flanker Inhibitory Control and Attention. |
| 4 weeks of treatment |
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |