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Alcohol and Neural Cardiovascular Control in Binge Drinkers

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ClinicalTrials.gov Identifier: NCT03567434
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
University of Chicago
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michigan Technological University

Brief Summary:
This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.

Condition or disease Intervention/treatment Phase
Binge Drinking Other: Alcohol vs. Placebo Not Applicable

Detailed Description:
This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Double-Blind, Placebo-Based Study to Determine Effect of Evening Alcohol on Sympathetic Neural Activity and Baroreflex Function in Binge Drinkers
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Intervention Details:
  • Other: Alcohol vs. Placebo
    Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
    Other Name: Ethanol


Primary Outcome Measures :
  1. Sympathetic nerve activity [ Time Frame: 1 month ]
    Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.


Secondary Outcome Measures :
  1. Baroreflex function [ Time Frame: 1 month ]
    The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.


Other Outcome Measures:
  1. Nocturnal blood pressure dip [ Time Frame: 1 month ]
    Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.

  2. Sleep quality [ Time Frame: 1 month ]
    Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.

  3. Sympathetic reactivity [ Time Frame: 1 month ]
    The change in muscle sympathetic nerve activity during an acute laboratory stressor.



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women age 21 - 40 years
  • Binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) definition of a "drink" will be used.
  • Women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., ~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation)
  • Willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered).

Exclusion Criteria:

  • Body mass index ≥ 35 kg/m2
  • Smokers
  • A physician diagnosis of diabetes
  • Pregnancy
  • Taking any cardiovascular medications
  • Severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour
  • Moderate-to-severe Alcohol Use Disorder (AUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
  • Individuals suspected to have mutant alcohol dehydrogenase 2 (ALDH2) isoenzyme as determined using a validated flushing questionnaire
  • Women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months

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): NCT03567434


Contacts
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Contact: Joanne Polzein 906-487-2902 jpolzien@mtu.edu
Contact: Cheryl Gherna 906-487-2902 cagherna@mtu.edu

Locations
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United States, Michigan
Michigan Technological University Recruiting
Houghton, Michigan, United States, 49931
Contact: Jason Carter         
Sponsors and Collaborators
Michigan Technological University
University of Chicago
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jason Carter Michigan Technological University

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Responsible Party: Michigan Technological University
ClinicalTrials.gov Identifier: NCT03567434     History of Changes
Other Study ID Numbers: M0785
1R01AA024892-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The scientific field of neural cardiovascular control in humans does not, at present, have a common data repository that would be applicable to this project. However, all data will be stored on secure University server in a de-identified manner, and investigators will make raw data available to individuals, groups, and organizations upon request and when appropriate.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Binge Drinking
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Drinking Behavior
Alcohol Drinking
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs