Clinical trial NCT03567434: Alcohol and Neural Cardiovascular Control in Binge Drinkers
Official title: 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
Overall status: COMPLETED
Phase: NA
Conditions: Binge Drinking
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-06-25
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sympathetic Nerve Activity Burst Frequency
timeFrame: 1 month
measure: Sympathetic Nerve Activity Burst Incidence
timeFrame: 1 month
Secondary outcomes:
measure: Spontaneous Sympathetic Baroreflex Sensitivity
timeFrame: 1 month
Other outcomes:
measure: Nocturnal Blood Pressure Dip
timeFrame: 1 month
measure: Sleep Quality
timeFrame: 1 month
measure: Sympathetic Reactivity
timeFrame: 1 month
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
affiliation: Baylor University
name: Jason Carter
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenlund IM, Bigalke JA, Tikkanen AL, Durocher JJ, Smoot CA, Carter JR. Evening binge alcohol disrupts cardiovagal tone and baroreflex function during polysomnographic sleep. Sleep. 2021 Nov 12;44(11):zsab130. doi: 10.1093/sleep/zsab130.