Recruiting

Alcohol Use Disorder

Sponsor:

Jessica Weafer

Code:

NCT04929288

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 26

Healthy Volunteers: Accepted

Interventions

Alcohol

Study Details

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 ID

NCT04929288

Start date

May 11, 2021

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 26

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Males

Participants in this group will be adult male drinkers.

experimental: Females

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

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.

Primary outcome measure

  • 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 ]
  • Self-reported current alcohol consumption [ Time Frame: 20 minutes ]
  • Prospective alcohol consumption [ Time Frame: 18 months ]
  • Prospective alcohol consumption [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jessica Weafer, PhD

More Information

Sponsor

Jessica Weafer

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jessica Weafer on 2026-05-22.