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临床试验/NCT00961792
NCT00961792进行中(未招募)不适用

Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults

University of Chicago2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2004年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
800
试验地点
2
主要终点
Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers

研究概览

简要总结

This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:

  1. Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.
  2. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.
  3. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21-65
  • Weigh between 110-210 lbs
  • Drink alcohol at least once weekly with weekly "binge" drinking episodes
  • Available to complete in-person screening and 2, 4 hour experimental sessions at the University of Chicago
  • Available by phone, mail, or Internet for follow-up interviews for at least 2 years following sessions

排除标准

  • Current or past major medical or psychiatric disorders including alcohol and substance dependence

研究组 & 干预措施

Beverage in Natural Environment

No Intervention

Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment

Beverage with No alcohol (Placebo)

Placebo Comparator

Beverage containing 0.0 g/kg alcohol to act as placebo

干预措施: Placebo (Drug)

Beverage with Low Alcohol Dose

Experimental

Beverage containing 0.4 g/kg alcohol

干预措施: Ethanol (Drug)

Beverage with Heavy Alcohol Dose

Experimental

Beverage containing 0.8 g/kg alcohol

干预措施: Ethanol (Drug)

Beverage with Caffeine

Experimental

Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

干预措施: Caffeine (Drug)

Beverage with Diphenhydramine

Experimental

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

干预措施: Diphenhydramine (Drug)

结局指标

主要结局

Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers

时间窗: Measured during 5 timepoints at each experimental session: 1) Pre-drink baseline, 2) +30 minutes, 3) +60 minutes, 4) +120 minutes, and 5) +180 minutes following the initiation of beverage consumption

次要结局

  • Substance Use Behavior Reported During Follow-Up Interviews(Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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