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Alcohol's Impact on Cardiovascular Control in Excessive Alcohol Consumption

N/A

Waitlist Available

Led By Jason Carter

Research Sponsored by Baylor University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women age 21 - 40 years

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial looks at how drinking alcohol in the evening affects sympathetic activity (the body's fight-or-flight response) and baroreflex function (the body's ability to regulate blood pressure) in people who drink heavily. They think that evening drinking will cause sympathetic overactivity and reduced baroreflex function.

Who is the study for?

This trial is for men and women aged 21-40 who are binge drinkers, defined as consuming ≥4 drinks for females or ≥5 drinks for males within a short time. Participants must have had such drinking episodes recently but cannot be smokers, pregnant, severely overweight, diabetic, on heart meds, or have certain sleep apnea. Women can't use hormonal contraceptives and must have regular menstrual cycles.Check my eligibility

What is being tested?

The study investigates how drinking a lot of alcohol in the evening affects nerve activity related to heart function and blood pressure control in people who regularly consume large amounts of alcohol quickly. It tests whether this kind of drinking leads to increased nerve activity that could affect the heart and dulls the body's ability to regulate blood pressure.See study design

What are the potential side effects?

Since this trial involves consumption of alcohol by participants known to engage in binge drinking behaviorally rather than testing a new drug or medical intervention directly, side effects may include typical acute responses to alcohol such as impaired coordination, drowsiness, nausea or hangover symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 40 years old.

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I am a woman with regular menstrual cycles lasting about 25-30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sympathetic nerve activity

Secondary outcome measures

Baroreflex function

Other outcome measures

Nocturnal blood pressure dip

Sleep quality

Sympathetic reactivity

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor UniversityLead Sponsor

56 Previous Clinical Trials

65,134 Total Patients Enrolled

Montana State UniversityLead Sponsor

44 Previous Clinical Trials

1,043,784 Total Patients Enrolled

University of ChicagoOTHER

1,004 Previous Clinical Trials

819,717 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I become a participant in this trial?

"This clinical trial is recruiting up to 60 participants aged between 21 and 40 who have been diagnosed with binge drinking. Other criteria include a pattern of consuming at least 4 drinks for women or 5 drinks for men in 2 hours on more than one occasion within the past 6 months, as well as adhering to the NIAAA drink definition. Women must be eumenorrheic and premenopausal with regular menstrual cycles while both sexes should abstain from exercise and caffeine 12 hours before any autonomic tests, and avoid alcohol 24 hours prior these same assessments (unless it's being administered experimentally)."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative. Data published on clinicaltrials.gov attests that recruitment for the study is still underway, with its initial posting taking place on May 21st 2018 and most recent update being April 7th 2022. The research requires 60 people to be recruited from a single location."

Answered by AI

Is enrollment open to individuals over the age of 45 for this clinical investigation?

"Participants that fit within this study's criteria must be between 21 and 40 years old."

Answered by AI

Are enrollment opportunities available for this research initiative?

"Affirmative. According to the clinicaltrials.gov database, this investigation has been live since May 21st 2018 and was most recently updated on April 7th 2021. Currently they are searching for 60 individuals from just one medical facility."

Answered by AI

Recent research and studies

SleepJournal

Evening Binge Alcohol Disrupts Cardiovagal Tone and Baroreflex Function During Polysomnographic Sleep

Greenlund, Ian M, Jeremy A Bigalke, Anne L Tikkanen, John J Durocher, Carl A Smoot, and Jason R Carter. 2021. “Evening Binge Alcohol Disrupts Cardiovagal Tone and Baroreflex Function During Polysomnographic Sleep”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/zsab130.

clinicaltrials.govStudy

Alcohol and Neural Cardiovascular Control in Binge Drinkers

2018. "Alcohol and Neural Cardiovascular Control in Binge Drinkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03567434.

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