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Neural and Hormonal Influences on Sex Differences in Risk for AUD

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04929288
Enrollment
100
Registered
2021-06-18
Start date
2021-05-11
Completion date
2027-06-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

sex, inhibitory control, risk factor, hormone, fMRI, menstrual cycle

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).

Interventions

DRUGAlcohol

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.

Sponsors

Jessica Weafer
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 26 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neural inhibitory function13 minutesOne measure of neural inhibitory function during performance of the stop signal task will be activity (as measured by BOLD % signal change)
Neural negative emotionality14 minutesOne measure of neural negative emotionality during performance of the Emotional Pictures Task will be activity (as measured by BOLD % signal change)
Neural alcohol cue reactivity12 minutesOne 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)60 minutesOne measure of IV-ASA will be peak BrAC (mg%; highest BrAC obtained during the IV-ASA period)
Self-reported current alcohol consumption20 minutesOne 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 consumption18 monthsOne measure of prospective alcohol consumption will be number of binge episodes as determined by responses on the 90-day Timeline Followback.

Countries

United States

Contacts

CONTACTJessica Weafer, PhD
Jessica.Weafer@osumc.edu614-366-0163
PRINCIPAL_INVESTIGATORJessica Weafer, PhD

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026