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临床试验/NCT05826951
NCT05826951已完成早期 1 期

Social Effects of Alcohol

University of Chicago1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年2月20日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
37
试验地点
1
主要终点
self-reported feelings of connection

研究概览

简要总结

In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

详细描述

The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • non-problem alcohol consumption of 2-20 drinks per week
  • high school diploma or equivalent
  • BMI between 19 and 26
  • verbal fluency in English

排除标准

  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Women who are pregnant or trying to become pregnant.

研究组 & 干预措施

Alcohol-alcohol

Experimental

Both conversation partners receive alcohol

干预措施: Alcohol (Drug)

placebo-placebo

Placebo Comparator

Both conversation partners receive placebo

干预措施: Placebo (Drug)

alcohol-placebo

Experimental

participant receives alcohol and conversation partner receives placebo

干预措施: Alcohol (Drug)

placebo-alcohol

Experimental

participant receives placebo and conversation partner receives alcohol

干预措施: Placebo (Drug)

结局指标

主要结局

self-reported feelings of connection

时间窗: at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed

self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection

facial emotional responses

时间窗: during the length of the conversation (45 min)

alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Social Effects of Alcohol | 临床试验