Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- cytokine levels
研究概览
简要总结
The purpose of this study is to examine potential stress and immune systems adaptations underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep). Using the investigators experimentally validated guided imagery procedure, the investigators propose to examine the response of brain stress and immune systems to personalized guided stressful imagery using subjective, physiological and neurobiological assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without depressive symptomatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADs: Male and females, aged 18-50 years, meeting current DSM-IV criteria for alcohol dependence consuming more than 25 drinks / week.
- •SDs: Male and females, aged 18-50 years. Must not meet either current or lifetime DSM-IV criteria for alcohol/drug abuse. They must have demonstrated weekly alcohol use over the past year but no more than 25 drinks / month with no occasion of binge drinking (5 or more drinks-men; 4 or more -women).
- •ADs and SDs must self-report depression ratings at levels to match one of the two following groups: a) a score of 20 or above in the Center for Epidemiologic Studies - Depression Scale (CES-D), or b) a score between 3 -20 on the CES-D
- •Weekly alcohol use as documented by positive urine toxicology screens (AD only).
- •Good health as verified by screening examinations and medical and screening
- •Able to read English and complete study evaluations.
- •All participants must voluntarily provide informed consent and sign the informed consent document.
排除标准
- •Meeting current criteria for dependence on another psychoactive substance, excluding nicotine.
- •Having any current Axis I psychiatric disorders and requiring treatment/medication for these conditions.
- •Having significant underlying medical conditions requiring medication.
- •Women who are pregnant or nursing.
结局指标
主要结局
cytokine levels
时间窗: Day 1 and 2, (-25, -5, +5, +15, +30, +45)
At each of the six time-points (-25, -5, +5, +15, +30, +45), serum cytokine concentrations of IL-6, TNFa, TNFR1, IL-10, IL1-ra, IL-4, IL1beta, and IL-12 will be collected. Levels will be determined by enzyme-linked immuno-sorbent assays using the DuoSet ELISA Development Kit from R\&D systems (Minneapolis, MN, USA). Plasma Cortisol and ACTH levels will also be colected and assays will be measured using standard radioimmunoassay procedures.
次要结局
- Alcohol Relapse(14, 30 and 90 day follow-ups)
- Alcohol Craving(Day 14, Day 30 and Day 90)
- Anxiety and Negative Mood(Day 14, Day 30 and Day 90)