Sex Differences in Risk for Alcohol Abuse

NCT04543942 | Completed Results

• 2 other identifiers: 50301K01AA024519-06
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse

Keywords

brain activation during response inhibition; BARI; fMRI; stop signal task; sex difference; menstrual; inhibitory control

Outcome Measures

Primary Outcomes (2)

• Brain Activation During Response Inhibition (BARI) - Alcohol Infusion

  Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

  During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

• Brain Activation During Response Inhibition (BARI) - Saline Infusion

  Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during saline infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

  During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Secondary Outcomes (14)

• Estradiol Levels - Alcohol Infusion

  During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

• Estradiol Levels - Saline Infusion

  During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

• Progesterone Levels - Alcohol Infusion

  During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

• Progesterone Levels - Saline Infusion

  During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

• Testosterone Levels - Alcohol Infusion

  During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

Study Arms (2)

Alcohol, then saline, then alcohol, then saline

EXPERIMENTAL

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.

Drug: Alcohol; Drug: Saline

Saline, then alcohol, then saline, then alcohol

EXPERIMENTAL

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.

Drug: Alcohol; Drug: Saline

Interventions

Alcohol DRUG

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

Alcohol, then saline, then alcohol, then saline; Saline, then alcohol, then saline, then alcohol

Saline DRUG

Saline is administered as the placebo

Alcohol, then saline, then alcohol, then saline; Saline, then alcohol, then saline, then alcohol

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Fillmore: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Sodium Chloride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jessica Weafer
• Organization: The Ohio State University

jessica.weafer@osumc.edu

859-533-9878

Study Officials

• Mark Fillmore, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: November 1, 2019
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)