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: Interventional
- Study Design
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 2022
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.
- 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
- Sympathetic nerve activity
- Time Frame: 1 month
- Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
- Baroreflex function
- Time Frame: 1 month
- The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Montana State University
- University of Chicago
- Provider of Information About this Clinical Study
- Overall Official(s)
- Jason Carter, Principal Investigator, Montana State University
- Overall Contact(s)
- Anne Tikkanen, 406-994-2292, firstname.lastname@example.org
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