Sex Differences in Risk for Alcohol Abuse

August 24, 2023 updated by: Mark Fillmore

Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University Of Kentucky Psychology Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brain Activation During Response Inhibition (BARI)
Time Frame: 4 weeks
Brain activation during response inhibition (BARI) will be assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task with alcohol compared to to placebo. Values will be determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Estradiol Levels
Time Frame: 4 weeks
Estradiol levels will be measured from blood samples with alcohol compared to to placebo.
4 weeks
Change in Progesterone Levels
Time Frame: 4 weeks
Progesterone levels will be measured from blood samples with alcohol compared to to placebo.
4 weeks
Change in Testosterone Levels
Time Frame: 4 weeks
Testosterone levels will be measured from blood samples with alcohol compared to to placebo.
4 weeks
Change in Biphasic Alcohol Effects Score
Time Frame: 4 weeks
The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 14 questions. Higher scores indicate increased stimulation or sedation. Scores will be reported with alcohol comparted to placebo.
4 weeks
Change in Drug Effects Questionnaire Score
Time Frame: 4 weeks
Drug Effects Questionnaire (DEQ) consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from "not at all" to "extremely." Scores are measured in millimeters from the scale origin. Higher scores (longer lengths) indicate greater drug effects. Scores will be reported with alcohol comparted to placebo.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Fillmore

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Mark Fillmore, Ph.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50301
  • K01AA024519-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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