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Alcohol and Neural Cardiovascular Control in Binge Drinkers

Primary Purpose

Binge Drinking

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcohol vs. Placebo

About this trial

This is an interventional basic science trial for Binge Drinking

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Montana State UniversityRecruiting

Outcomes

Primary Outcome Measures

Sympathetic nerve activity

Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

Secondary Outcome Measures

Baroreflex function

The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.

Full Information

NCT ID

NCT03567434

First Posted

May 24, 2018

Last Updated

April 7, 2022

Sponsor

Montana State University

Collaborators

University of Chicago, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT03567434

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 21, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montana State University

Collaborators

University of Chicago, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Drinking

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Alcohol vs. Placebo

Other Intervention Name(s)

Ethanol

Intervention Description

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

Primary Outcome Measure Information:

Title

Sympathetic nerve activity

Description

Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Baroreflex function

Description

The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity.

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Nocturnal blood pressure dip

Description

Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.

Time Frame

1 month

Title

Sleep quality

Description

Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.

Time Frame

1 month

Title

Sympathetic reactivity

Description

The change in muscle sympathetic nerve activity during an acute laboratory stressor.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Tikkanen

Phone

406-994-2292

anne.tikkanen@montana.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ian Greenlund

Phone

406-994-2292

ian.greenlund@student.montana.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Carter

Organizational Affiliation

Montana State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montana State University

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59717

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jason Carter

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The scientific field of neural cardiovascular control in humans does not, at present, have a common data repository that would be applicable to this project. However, all data will be stored on secure University server in a de-identified manner, and investigators will make raw data available to individuals, groups, and organizations upon request and when appropriate.

Citations:

PubMed Identifier

34015116

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.

Results Reference

derived

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Alcohol and Neural Cardiovascular Control in Binge Drinkers

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