Alcohol and Neural Cardiovascular Control in Binge Drinkers

NCT03567434 | Completed Results DMC

• 2 other identifiers: JC080420-FC1R01AA024892-01A1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Drinking

Outcome Measures

Primary Outcomes (2)

• Sympathetic Nerve Activity Burst Frequency

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

  1 month

• Sympathetic Nerve Activity Burst Incidence

  Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.

  1 month

Secondary Outcomes (1)

• Spontaneous Sympathetic Baroreflex Sensitivity

  1 month

Other Outcomes (3)

• Nocturnal Blood Pressure Dip

  1 month

• Sleep Quality

  1 month

• Sympathetic Reactivity

  1 month

Study Arms (2)

Fluid Control

PLACEBO COMPARATOR

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.

Other: Alcohol vs. Placebo

Alcohol

EXPERIMENTAL

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.

Other: Alcohol vs. Placebo

Interventions

Alcohol vs. Placebo 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.

Also known as: Ethanol

Alcohol; Fluid Control

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor University: lead
• University of Chicago: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

Related Publications (2)

• 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.

  PMID: 39119705 DERIVED

• 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.

  PMID: 34015116 DERIVED

MeSH Terms

Conditions

Binge Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Jason Carter
• Organization: Baylor University

jason_carter1@baylor.edu

254-710-4499

Study Officials

• Jason Carter

  Baylor University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 25, 2018
• Study Start: May 21, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 24, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)