Alcohol and Neural Cardiovascular Control in Binge Drinkers

Binge Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03567434
• Other study ID #: JC080420-FC
• Secondary ID: 1R01AA024892-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2023
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Drinking

Intervention

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.

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (3)

Lead Sponsor	Collaborator
Baylor University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nocturnal blood pressure dip	Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.	1 month
Other	Sleep quality	Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.	1 month
Other	Sympathetic reactivity	The change in muscle sympathetic nerve activity during an acute laboratory stressor.	1 month
Primary	Sympathetic nerve activity	Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.	1 month
Secondary	Baroreflex function	The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.	1 month