Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04929288

Neural and Hormonal Influences on Sex Differences in Risk for AUD

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Coitus Mental Disorders Sexual Behavior Substance-Related Disorders

Age range

21 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Jessica Weafer

CONTACT

[email protected]

614-366-0163

Jessica Weafer, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Drug

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.

Primary outcomes

  1. Neural inhibitory function

    Time frame: 13 minutes

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

  2. Neural inhibitory function

    Time frame: 13 minutes

    The other measure of neural inhibitory function during performance of the stop signal task will be functional connectivity for the StopInh>Go contrast.

  3. Neural negative emotionality

    Time frame: 14 minutes

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

  4. Neural negative emotionality

    Time frame: 14 minutes

    The other measure of neural negative emotionality during performance of the Emotional Pictures Task will be functional connectivity for the Negative>Neutral contrast.

  5. Neural alcohol cue reactivity

    Time frame: 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)

  6. Neural alcohol cue reactivity

    Time frame: 12 minutes

    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.

  7. Intravenous alcohol self-administration (IV-ASA)

    Time frame: 60 minutes

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

  8. Intravenous alcohol self-administration (IV-ASA)

    Time frame: 60 minutes

    Another measure of IV-ASA will be whether or not a participant reached binge level of alcohol exposure (80mg%)

  9. Intravenous alcohol self-administration (IV-ASA)

    Time frame: 60 minutes

    The final measure of IV-ASA will be time to reach binge level of alcohol exposure (80mg%)

  10. Self-reported current alcohol consumption

    Time frame: 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.

  11. Self-reported current alcohol consumption

    Time frame: 20 minutes

    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.

  12. Prospective alcohol consumption

    Time frame: 18 months

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

  13. Prospective alcohol consumption

    Time frame: 18 months

    The other measure of prospective alcohol consumption will be drinking days per month, as determined by responses on the 90-day Timeline Followback.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Weafer, PhD

CONTACT

[email protected]

614-366-0163

Sponsors and collaborators

Lead sponsor

Jessica Weafer

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.