Alcohol and Neural Cardiovascular Control in Binge Drinkers

NCT ID: NCT03567434

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2022-07-01

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.

Conditions

Binge Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Fluid Control

Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.

Group Type: PLACEBO_COMPARATOR

Alcohol vs. Placebo

Intervention Type: OTHER

Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.

Alcohol

Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.

Group Type: EXPERIMENTAL

Alcohol vs. Placebo

Intervention Type: OTHER

Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Ethanol

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Carter

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

Montana State University

Bozeman, Montana, United States

Countries

United States

References

Bigalke JA, Greenlund IM, Solis-Montenegro TX, Durocher JJ, Joyner MJ, Carter JR. Binge Alcohol Consumption Elevates Sympathetic Transduction to Blood Pressure: A Randomized Controlled Trial. Hypertension. 2024 Oct;81(10):2140-2151. doi: 10.1161/HYPERTENSIONAHA.124.23416. Epub 2024 Aug 9.

Reference Type: DERIVED

PMID: 39119705 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34015116 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R01AA024892-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JC080420-FC

Identifier Type: -

Identifier Source: org_study_id