Neural and Hormonal Influences on Sex Differences in Risk for AUD

NCT ID: NCT04929288

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2026-06-30

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).

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Males

Participants in this group will be adult male drinkers.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: 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.

Females

Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: 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.

Interventions

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 pharmacologically-driven alcohol consumption.

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Jessica Weafer

OTHER

Sponsor Role: lead

Responsible Party

Jessica Weafer

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jessica Weafer, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Weafer, PhD

Role: CONTACT

Jessica.Weafer@osumc.edu

614-366-0163

Facility Contacts

Jessica Weafer

Role: primary

jessica.weafer@osumc.edu

614-366-0163

Other Identifiers

R01AA028503

Identifier Type: NIH

Identifier Source: secondary_id

View Link

58758

Identifier Type: -

Identifier Source: org_study_id