Alcohol and Neural Cardiovascular Control in Binge Drinkers

Overview

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.

Full Title of Study: “Randomized, Double-Blind, Placebo-Based Study to Determine Effect of Evening Alcohol on Sympathetic Neural Activity and Baroreflex Function in Binge Drinkers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2022

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sympathetic nerve activity
    • Time Frame: 1 month
    • Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

Secondary Measures

  • Baroreflex function
    • Time Frame: 1 month
    • The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 21 Years

    Maximum Age: 40 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Montana State University
    • Collaborator
      • University of Chicago
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Jason Carter, Principal Investigator, Montana State University
    • Overall Contact(s)
      • Anne Tikkanen, 406-994-2292, anne.tikkanen@montana.edu

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.