Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Plasma lipopolysaccharide binding protein (ng/ml)
研究概览
简要总结
This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 21-55 years
- •Able to speak and read English
- •Regular use of alcohol
- •Weight > or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range
- •No self-reported use of drugs
排除标准
- •Currently seeking treatment for alcohol or drug use
- •Chronic disease
- •Use of certain medications
- •GI disorders
- •Daily/near-daily use of NSAIDs
- •Positive urine test for certain drugs
- •History of withdrawal symptoms precipitated by alcohol abstinence
- •Clinical Institute Withdrawal Assessment for Alcohol score greater than or equal to 10
- •History of seizures
- •Current major psychiatric disorder
- •History of adverse reaction to standard blood draw
- •Inability to abstain from tobacco for 8 hours
- •Inability to abstain from cannabis for 48 hours
- •Pregnant, breastfeeding, or may become pregnant
研究组 & 干预措施
Alcohol, placebo
Alcohol, ethyl - Placebo
干预措施: Alcohol, Ethyl (Drug)
Alcohol, placebo
Alcohol, ethyl - Placebo
干预措施: Alcohol, Ethyl - placebo (Other)
Alcohol, low dose
Alcohol, ethyl - Low dose
干预措施: Alcohol, Ethyl (Drug)
Alcohol, low dose
Alcohol, ethyl - Low dose
干预措施: Alcohol, Ethyl - placebo (Other)
Alcohol, moderate dose
Alcohol, ethyl - Moderate dose
干预措施: Alcohol, Ethyl (Drug)
Alcohol, moderate dose
Alcohol, ethyl - Moderate dose
干预措施: Alcohol, Ethyl - placebo (Other)
结局指标
主要结局
Plasma lipopolysaccharide binding protein (ng/ml)
时间窗: 0-4 hours
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
Soluble cluster of differentiation 14 (ng/ml)
时间窗: 0-4 hours
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
Soluble cluster of differentiation 163 (ng/ml)
时间窗: 0-4 hours
Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml
Plasma lipopolysaccharide (pg/ml)
时间窗: 0-4 hours
Plasma concentration of lipopolysaccharide, measured in picograms/ml
次要结局
- Response time in ms(0-4 hours)
研究者
Mollie Monnig
Assistant Professor of Behavioral and Social Sciences
Brown University