Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04929288

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
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Jessica Weafer · Academic / Other
Sex
All
Age
21 Years – 26 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGAlcoholParticipants 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.

Timeline

Start date
2021-05-11
Primary completion
2027-06-30
Completion
2027-06-30
First posted
2021-06-18
Last updated
2026-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04929288. Inclusion in this directory is not an endorsement.