Neural and Hormonal Influences on Sex Differences in Risk for AUD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alcohol.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: 21 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
Overview
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).
Interventions
- Drug 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
Primary outcome measures
- Neural inhibitory function [Time frame: 13 minutes]
- Neural inhibitory function [Time frame: 13 minutes]
- Neural negative emotionality [Time frame: 14 minutes]
- Neural negative emotionality [Time frame: 14 minutes]
- Neural alcohol cue reactivity [Time frame: 12 minutes]
- Neural alcohol cue reactivity [Time frame: 12 minutes]
- Intravenous alcohol self-administration (IV-ASA) [Time frame: 60 minutes]
- Intravenous alcohol self-administration (IV-ASA) [Time frame: 60 minutes]
- Intravenous alcohol self-administration (IV-ASA) [Time frame: 60 minutes]
- Self-reported current alcohol consumption [Time frame: 20 minutes]
Eligibility criteria
Inclusion criteria
- consume 4/5 drinks per week
- fluent in English
- high school education
- right-handed
- regular menstrual cycles (women)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- The Ohio State University — Columbus
Identifiers
NCT: NCT04929288 · 58758 · R01AA028503