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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 21 Years and 26 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Males
Participants in this group will be adult male drinkers.
  • Drug: 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.
Experimental
Females
Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.
  • Drug: 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University Of Kentucky Psychology Research Lab
Lexington, Kentucky 40504
Contact:
Study Coordinator
859-257-5794
psychresearch@uky.edu

More Details

NCT ID
NCT04929288
Status
Recruiting
Sponsor
Jessica Weafer

Study Contact

Study Coordinator
8592575794
psychresearch@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.