Alcohol and Neural Cardiovascular Control in Binge Drinkers



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 40
Updated:6/27/2018
Start Date:May 21, 2018
End Date:September 2022
Contact:Joanne Polzein
Email:jpolzien@mtu.edu
Phone:906-487-2902

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

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.

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
We found this trial at
1
site
1400 Townsend Drive
Houghton, Michigan 49931
?
mi
from
Houghton, MI
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