Neural and Hormonal Influences on Sex Differences in Risk for AUD

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jessica Weafer
Study ID
NCT04929288
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 26 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
May 11, 2021
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Neural inhibitory function [ Time Frame: 13 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Jessica Weafer
[email protected]
614-366-0163
Jessica Weafer, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
The Ohio State University· Columbus, OH

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