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临床试验/NCT06687525
NCT06687525进行中(未招募)不适用

Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
试验地点
2
主要终点
Inter-brain entrainment

研究概览

简要总结

In this study, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

详细描述

Objective

Alcohol's ability to boost mood in the face of stress is perhaps its most notoriously addictive property, long held by researchers to be of critical importance for understanding alcohol use disorder (AUD) etiology. Yet, while most real-world alcohol consumption occurs in social settings, in the context of laboratory studies, participants have almost always consumed alcohol alone. The discrepancy between real-world and laboratory contexts emerges as particularly stark in the neuroimaging literature, where no alcohol-administration study to date has incorporated in-vivo social context. In this first alcohol-administration study to leverage EEG hyperscanning methods, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

Specifically, this study aims to characterize the mechanisms driving social reward from alcohol in the context of stress and elucidate the role of social processes and novel social context in driving problem drinking.

Study Population: Participants will consist of 240 regular drinkers, aged 21-30, with no reported history of severe alcohol use disorder.

Design: In the laboratory arm of the study, individuals will be randomly assigned to consume either a moderate dose of alcohol or a control beverage in stranger dyads. Participants will engage in both structured and unstructured tasks aimed at assessing social engagement and threat sensitivity. EEG and ERP data will be collected from both participants simultaneously. In the ambulatory study arm, participants will wear transdermal sensors to assess BAC and will further provide information about their mood and their social contexts in response to random prompts.

Outcome Measures: Primary outcome measures include EEG measures of inter-brain entrainment as well as ERP metrics derived from task contexts (both players and observers). Additional outcomes include measures of positive mood, negative mood, and social bonding. Finally, drinking behaviors will be assessed via transdermal ambulatory alcohol sensors and longitudinal self-reports of drinking.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 21 and 30
  • Regularly consumes alcohol

排除标准

  • History of adverse reaction to the amount of beverage employed in the study
  • Have a history of major problems associated with alcohol
  • Take medications that could adversely interact with alcohol
  • Have medical conditions that contraindicate alcohol administration
  • Individuals with a history of skull fractures or who indicate discomfort with EEG procedures used
  • Female participant is pregnant or trying to become pregnant

结局指标

主要结局

Inter-brain entrainment

时间窗: During active laboratory beverage manipulation exposure (during or immediately after beverage administration, at which time participants in the alcohol condition will register a positive BAC)

The association between dyad-members EEG signals during the hyperscanning task

Feedback-related negativity

时间窗: During active laboratory beverage manipulation exposure (during or immediately after beverage administration, at which time participants in the alcohol condition will register a positive BAC)

An ERP component calculated from a time-estimation task

Ambulatory Drinking

时间窗: 14 days

Drinking behavior assessed outside the laboratory using ambulatory assessment

Longitudinal Drinking Problems

时间窗: Up to 24 months post-baseline

Drinking assessed at longitudinal follow-up

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 (2)

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