Neural and Hormonal Influences on Sex Differences in Risk for AUD

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Alcohol
  Participants will complete three experimental sessions. In each session, participants will provide detailed reports of their alcohol consumption over the past five days, and they will provide a blood sample for hormone assays. They will perform tasks during fMRI to assess each of the neurofunctional addiction domains: inhibitory control, negative emotionality, and cue reactivity. Following the fMRI scan, subjects will self-administer intravenous alcohol to provide a controlled assessment of phar

Первичные конечные точки

• Neural inhibitory function [Срок оценки: 13 minutes]
• Neural inhibitory function [Срок оценки: 13 minutes]
• Neural negative emotionality [Срок оценки: 14 minutes]
• Neural negative emotionality [Срок оценки: 14 minutes]
• Neural alcohol cue reactivity [Срок оценки: 12 minutes]
• Neural alcohol cue reactivity [Срок оценки: 12 minutes]
• Intravenous alcohol self-administration (IV-ASA) [Срок оценки: 60 minutes]
• Intravenous alcohol self-administration (IV-ASA) [Срок оценки: 60 minutes]
• Intravenous alcohol self-administration (IV-ASA) [Срок оценки: 60 minutes]
• Self-reported current alcohol consumption [Срок оценки: 20 minutes]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The Ohio State University — Columbus

Идентификаторы

NCT: NCT04929288 · 58758 · R01AA028503

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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