Sex Differences in Risk for Alcohol Abuse

NCT ID: NCT04543942

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-05-24

Brief Summary

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

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.

Conditions

Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Alcohol, then saline, then alcohol, then saline

Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

Alcohol will be administered by IV infusion (60mg%).

Saline

Intervention Type: DRUG

Saline is administered as the placebo

Saline, then alcohol, then saline, then alcohol

Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

Alcohol will be administered by IV infusion (60mg%).

Saline

Intervention Type: DRUG

Saline is administered as the placebo

Interventions

Alcohol

Alcohol will be administered by IV infusion (60mg%).

Intervention Type: DRUG

Saline

Saline is administered as the placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Mark Fillmore

OTHER

Sponsor Role: lead

Responsible Party

Mark Fillmore

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark Fillmore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K01AA024519-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

50301

Identifier Type: -

Identifier Source: org_study_id