Alcohol and Neural Cardiovascular Control in Binge Drinkers

Sponsor

Montana State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03567434

Collaborator

University of Chicago (Other), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

63.4

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

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

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Outcome Measures

Primary Outcome Measures

Sympathetic nerve activity [1 month]
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

Secondary Outcome Measures

Baroreflex function [1 month]
The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.

Other Outcome Measures

Nocturnal blood pressure dip [1 month]
Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.
Sleep quality [1 month]
Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.
Sympathetic reactivity [1 month]
The change in muscle sympathetic nerve activity during an acute laboratory stressor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montana State University	Bozeman	Montana	United States	59717

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jason Carter, Montana State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montana State University

ClinicalTrials.gov Identifier:

NCT03567434

Other Study ID Numbers:

JC080420-FC
1R01AA024892-01A1

First Posted:

Jun 25, 2018

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Binge Drinking

Ethanol

Study Results

No Results Posted as of Apr 11, 2022