Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Peripheral Cytokine: IL-1B
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Call study team for additional screening and information.
排除标准
- 未提供
研究组 & 干预措施
Citicoline
2000mg/day citicoline for 4 weeks, administered orally
干预措施: Citicoline (cytidine diphosphate-choline) (Drug)
Placebo
placebo capsule daily for 4 weeks, matched in appearance to citicoline to preserve double-blind, administered orally
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Peripheral Cytokine: IL-1B
时间窗: 4 weeks of treatment
Peripheral cytokine (IL-1B) to measure neuroinflammation.
Peripheral Cytokine: IL-6
时间窗: 4 weeks of treatment
Peripheral cytokine (IL-6) to measure neuroinflammation.
Peripheral Cytokine: TNFα
时间窗: 4 weeks of treatment
Peripheral cytokine (TNFα) to measure neuroinflammation.
Brain Metabolite: Choline
时间窗: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (choline) in the anterior cingulate.
Neurocognition: Behavioral impulsivity
时间窗: 4 weeks of treatment
Behavioral impulsivity will be measured via the Behavioral Approach/Avoidance Scales (BIS/BAS).
Neurocognition: Inhibitory Control and Attention
时间窗: 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
时间窗: 4 weeks of treatment
Magnetic resonance spectroscopy to quantify neurometabolites (N-acetyl-aspartate) in the anterior cingulate.
Neurocognition: Cognitive Flexibility and Attention
时间窗: 4 weeks of treatment
Cognitive flexibility and attention will be measured via the NIH Toolbox Dimensional Change Card Sort.
次要结局
未报告次要终点
研究者
Lindsay Squeglia
Associate Professor
Medical University of South Carolina