Neural and Hormonal Influences on Sex Differences in Risk for AUD
Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
2 other identifiers
interventional
100
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2020
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 5, 2026
February 1, 2026
6.1 years
November 11, 2020
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Neural inhibitory function
One measure of neural inhibitory function during performance of the stop signal task will be activity (as measured by BOLD % signal change)
13 minutes
Neural inhibitory function
The other measure of neural inhibitory function during performance of the stop signal task will be functional connectivity for the StopInh\>Go contrast.
13 minutes
Neural negative emotionality
One measure of neural negative emotionality during performance of the Emotional Pictures Task will be activity (as measured by BOLD % signal change)
14 minutes
Neural negative emotionality
The other measure of neural negative emotionality during performance of the Emotional Pictures Task will be functional connectivity for the Negative\>Neutral contrast.
14 minutes
Neural alcohol cue reactivity
One measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be activity (as measured by BOLD % signal change)
12 minutes
Neural alcohol cue reactivity
The other measure of neural alcohol cue reactivity during performance of the Alcohol Cue Reactivity Task will be functional connectivity for the Alcohol\>Neutral contrast.
12 minutes
Intravenous alcohol self-administration (IV-ASA)
One measure of IV-ASA will be peak BrAC (mg%; highest BrAC obtained during the IV-ASA period)
60 minutes
Intravenous alcohol self-administration (IV-ASA)
Another measure of IV-ASA will be whether or not a participant reached binge level of alcohol exposure (80mg%)
60 minutes
Intravenous alcohol self-administration (IV-ASA)
The final measure of IV-ASA will be time to reach binge level of alcohol exposure (80mg%)
60 minutes
Self-reported current alcohol consumption
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.
20 minutes
Self-reported current alcohol consumption
The other measure of current alcohol consumption will be average peak BrAC obtained on drinking days over the past 5 days, as determined by responses on the Timeline Followback.
20 minutes
Prospective alcohol consumption
One measure of prospective alcohol consumption will be number of binge episodes as determined by responses on the 90-day Timeline Followback.
18 months
Prospective alcohol consumption
The other measure of prospective alcohol consumption will be drinking days per month, as determined by responses on the 90-day Timeline Followback.
18 months
Study Arms (2)
Males
EXPERIMENTALParticipants in this group will be adult male drinkers.
Females
EXPERIMENTALParticipants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.
Interventions
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 pharmacologically-driven alcohol consumption.
Eligibility Criteria
You may qualify if:
- consume 4/5 drinks per week
- fluent in English
- high school education
- right-handed
- regular menstrual cycles (women)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Weafer, PhD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 11, 2020
First Posted
June 18, 2021
Study Start
May 11, 2021
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share