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临床试验/NCT03467191
NCT03467191进行中(未招募)早期 1 期

Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting

Carnegie Mellon University1 个研究点 分布在 1 个国家目标入组 782 人开始时间: 2018年2月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
782
试验地点
1
主要终点
Change from Baseline Alcohol Use at 12-months

研究概览

简要总结

This study aims to identify risk factors that prospectively predict alcohol problems in young adults.

详细描述

The vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. This study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. Participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives.

N=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. Subjective and objective responses to alcohol will be assessed. Participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. Follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.

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, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 21 to 29 years of age
  • currently drinks alcohol
  • owns a smartphone

排除标准

  • [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]

研究组 & 干预措施

Alcohol Beverage

Experimental

Moderate dose of alcohol (target BAC .08%)

干预措施: Alcohol (Drug)

Placebo Beverage

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Change from Baseline Alcohol Use at 12-months

时间窗: 12-month follow-up

Timeline Follow Back Method

Change from Baseline Alcohol Use Disorder Symptoms at 12-months

时间窗: 12-month follow-up

Structured Clinical Interview for DSM-5

次要结局

  • Social Bonding(1 day (laboratory session))
  • Alcohol Use(21-day ambulatory assessment period)
  • Subjective Responses to Alcohol(1 day (laboratory session) and 21-day ambulatory assessment period)
  • Mood(1 day (laboratory session))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kasey Creswell

Associate Professor

Carnegie Mellon University

研究点 (1)

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