Sex Differences in Risk for Alcohol Abuse

Alcohol Abuse Clinical Trial

Official title:

Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543942
• Other study ID #: 50301
• Secondary ID: K01AA024519-06
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 24, 2023

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	University Of Kentucky Psychology Research Lab	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Mark Fillmore	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brain Activation During Response Inhibition (BARI)	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	Change in Estradiol Levels	Estradiol levels will be measured from blood samples with alcohol compared to to placebo.	4 weeks
Secondary	Change in Progesterone Levels	Progesterone levels will be measured from blood samples with alcohol compared to to placebo.	4 weeks
Secondary	Change in Testosterone Levels	Testosterone levels will be measured from blood samples with alcohol compared to to placebo.	4 weeks
Secondary	Change in Biphasic Alcohol Effects Score	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
Secondary	Change in Drug Effects Questionnaire Score	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