Clinical trial NCT04929288: Neural and Hormonal Influences on Sex Differences in Risk for AUD
Official title: Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: sex
inhibitory control
risk factor
hormone
fMRI
menstrual cycle
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Neural inhibitory function
timeFrame: 13 minutes
measure: Neural inhibitory function
timeFrame: 13 minutes
measure: Neural negative emotionality
timeFrame: 14 minutes
measure: Neural negative emotionality
timeFrame: 14 minutes
measure: Neural alcohol cue reactivity
timeFrame: 12 minutes
measure: Neural alcohol cue reactivity
timeFrame: 12 minutes
measure: Intravenous alcohol self-administration (IV-ASA)
timeFrame: 60 minutes
measure: Intravenous alcohol self-administration (IV-ASA)
timeFrame: 60 minutes
measure: Intravenous alcohol self-administration (IV-ASA)
timeFrame: 60 minutes
measure: Self-reported current alcohol consumption
timeFrame: 20 minutes
measure: Self-reported current alcohol consumption
timeFrame: 20 minutes
measure: Prospective alcohol consumption
timeFrame: 18 months
measure: Prospective alcohol consumption
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jessica Weafer, PhD
role: PRINCIPAL_INVESTIGATOR
References: