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临床试验/NCT04929288
NCT04929288招募中不适用

Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences

Jessica Weafer1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月11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
招募中
发起方
入组人数
100
试验地点
1
主要终点
Neural inhibitory function

研究概览

简要总结

The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown.

The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • consume 4/5 drinks per week
  • fluent in English
  • high school education
  • right-handed
  • regular menstrual cycles (women)

排除标准

  • serious medical problems
  • body weight <110 or >210 lbs
  • current medical or psychiatric conditions requiring medication for which alcohol is contraindicated
  • substance use disorder other than alcohol
  • current or recent history of inpatient/intensive treatment for addictive behaviors
  • pregnant, nursing, on hormonal contraception
  • contraindications for fMRI
  • smoking > 5 cigarettes per day

研究组 & 干预措施

Males

Experimental

Participants in this group will be adult male drinkers.

干预措施: Alcohol (Drug)

Females

Experimental

Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.

干预措施: Alcohol (Drug)

结局指标

主要结局

Neural inhibitory function

时间窗: 13 minutes

One measure of neural inhibitory function during performance of the stop signal task will be activity (as measured by BOLD % signal change)

Neural negative emotionality

时间窗: 14 minutes

One measure of neural negative emotionality during performance of the Emotional Pictures Task will be activity (as measured by BOLD % signal change)

Neural alcohol cue reactivity

时间窗: 12 minutes

One measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be activity (as measured by BOLD % signal change)

Intravenous alcohol self-administration (IV-ASA)

时间窗: 60 minutes

One measure of IV-ASA will be peak BrAC (mg%; highest BrAC obtained during the IV-ASA period)

Self-reported current alcohol consumption

时间窗: 20 minutes

One measure of current alcohol consumption will be number of binge days (4/5 or more drinks in a sitting for women/men) as determined by responses on the Timeline Followback.

Prospective alcohol consumption

时间窗: 18 months

One measure of prospective alcohol consumption will be number of binge episodes as determined by responses on the 90-day Timeline Followback.

次要结局

未报告次要终点

研究者

发起方
Jessica Weafer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jessica Weafer

Associate Professor

Ohio State University

研究点 (1)

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