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Completed

NCT Number: NCT03567434

Alcohol and Neural Cardiovascular Control in Binge Drinkers

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.

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montana State University

Bozeman, Montana, 59717, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol vs. Placebo

Other

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 names: Ethanol

Primary outcomes

  1. Sympathetic Nerve Activity Burst Frequency

    Time frame: 1 month

    Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.

  2. Sympathetic Nerve Activity Burst Incidence

    Time frame: 1 month

    Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.

Secondary outcomes

  1. Spontaneous Sympathetic Baroreflex Sensitivity

    Time frame: 1 month

    The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2018
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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