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Sex Differences in Risk for Alcohol Abuse

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ClinicalTrials.gov Identifier: NCT04543942
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : May 17, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jessica Weafer, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Drug: Alcohol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

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 Name: 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 Name: ethyl alcohol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Estradiol Levels [ Time Frame: 4 weeks ]
    Estradiol levels will be measured from blood samples with alcohol compared to to placebo.

  2. Change in Progesterone Levels [ Time Frame: 4 weeks ]
    Progesterone levels will be measured from blood samples with alcohol compared to to placebo.

  3. Change in Testosterone Levels [ Time Frame: 4 weeks ]
    Testosterone levels will be measured from blood samples with alcohol compared to to placebo.

  4. 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.

  5. 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.



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Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543942


Contacts
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Contact: Study Coordinator 859-257-5794 psychresearch@uky.edu

Locations
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United States, Kentucky
University Of Kentucky Psychology Research Lab Recruiting
Lexington, Kentucky, United States, 40504
Contact: Study Coordinator    859-257-5794    psychresearch@uky.edu   
Principal Investigator: Jessica Weafer, Ph.D.         
Sponsors and Collaborators
Jessica Weafer
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jessica Weafer, Ph.D. University of Kentucky
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Responsible Party: Jessica Weafer, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04543942    
Other Study ID Numbers: 50301
K01AA024519-06 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jessica Weafer, University of Kentucky:
brain activation during response inhibition
BARI
fMRI
stop signal task
sex difference
menstrual
inhibitory control
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs