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Purpose

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Condition

Eligibility

Eligible Ages
Between 21 Years and 29 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • heavy drinking
  • Alcohol Use Disorder Identification Test score above 7
  • right-handed
  • BMI between 19 and 26
  • high school education
  • fluent in English
  • women must have regular menstrual cycles
  • not using hormonal contraceptives

Exclusion Criteria

  • drug use disorder (SCID, DSM-5), other than nicotine or caffeine
  • meets withdrawal criteria
  • history of physical or psychiatric disease
  • contraindication for fMRI
  • pregnant or breastfeeding
  • smoking more than 5 cigarettes per day

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Males
Participants in this group will be adult male heavy drinkers.
  • Drug: Alcohol
    Alcohol will be administered by IV infusion (60mg%). Brain activation during response inhibition (BARI) will be assessed using fMRI during performance of the stop signal task.
    Other names:
    • ethyl alcohol
Experimental
Females
Participants in this group will be adult female heavy drinkers. Data will be segregated by menstrual cycle phase - the late follicular or mid-luteal phase.
  • Drug: Alcohol
    Alcohol will be administered by IV infusion (60mg%). Brain activation during response inhibition (BARI) will be assessed using fMRI during performance of the stop signal task.
    Other names:
    • ethyl alcohol

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
NCT04543942
Status
Recruiting
Sponsor
Jessica Weafer

Study Contact

Study Coordinator
859-257-5794
psychresearch@uky.edu

Detailed Description

Alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Knowing who is at risk for alcohol abuse, and why, is crucial for the development of effective prevention and treatment strategies. Alcohol abuse has been traditionally considered a male-oriented problem and as a consequence research on risk factors specific to women has been minimal. However, the sex gap in substance abuse is closing rapidly, and findings from both animal and human studies suggest that females are actually more vulnerable to drug use than males. As such, there is an urgent need to identify sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention and treatment efforts. One clear candidate risk factor is poor inhibitory control, both in terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of alcohol. Recent studies suggest that sex hormones affect inhibitory control in drug-free individuals, potentially contributing to sex differences in baseline levels of inhibition. However, the degree to which fluctuations in sex hormones influence sex differences in inhibition-related brain function in sober and intoxicated individuals is not known. The proposed project will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

The overall objective of the research is to identify hormonal determinants of alcohol effects on brain activation during response inhibition (BARI) in young adult female and male drinkers. BARI will be assessed using functional magnetic resonance imaging (fMRI) during performance of the stop signal task. This task reliably activates right-lateralized prefrontal regions implicated in inhibitory control. This study will assess BARI during IV alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal phases and in men at matched intervals.

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.