Neural and Hormonal Influences on Sex Differences in Risk for AUD

Jessica Weafer

Status: Enrolling

Conditions: Alcohol Use Disorder

Treatments: Drug: Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04929288

58758

R01AA028503 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Males

Experimental group

Description:

Participants in this group will be adult male drinkers.

Treatment:

Drug: Alcohol

Females

Experimental group

Description:

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

Treatment:

Drug: Alcohol