Expired Study
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Bethlehem, Pennsylvania 18015


Purpose:

This will be a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21 to consume beer on hospital property in a safe environment to ensure immediate availability to medical attention and to security if needed. Volunteers will be recruited from residency programs, hospital employees, emergency medical personnel, and friends of study investigators. The volunteers will drink to a BAC of 0.1 as checked with a breathalyzer. They will wear a tag around their neck with their study number, which will be hole-punched with every beer consumed, which will be collected at the end of the night for an accurate count of beers consumed per person. They however will not be forced to drink anymore if they are uncomfortable with the amount of alcohol they are consuming and can withdraw from the study at any time. All participants will be required to be driven home by a sober driver once the participant's BAT is 0.02 or less. At the end of the night, the volunteer will be breathalyzed to determine BAC, and given 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point Hangover Symptom Severity scale. A random number generator will be used to determine Placebo or NAC first, then the participant will be given the other treatment at their subsequent encounter. The study will be conducted over the series of many months, and data can be analyzed by self-control comparing the participant's hangover symptom severity as determined by the hangover symptom scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.


Criteria:

Inclusion Criteria: - healthy volunteers over age 21 years Exclusion Criteria: - Volunteers will be excluded from the study if they suffer from any of the following conditions: - Alcoholism, - Pregnancy, - Reactive Airway Disease, - Diabetes, - Kidney or bladder stones, - Kidney disease, - Liver disease, - Stomach ulcer, - Organ transplant patients, - Dialysis patients, - and patients with alcohol, egg, milk or wheat allergies. Volunteers taking the following medications will not be able to participate: - activated charcoal, - ampicillin, - carbamazepine, - cephaloridine, - cloxacillin, - methicillin, - nitroglycerine, - oxacillin, - penicillin G, - or quinacillin.


NCT ID:

NCT02541422


Primary Contact:

Principal Investigator
Holly A Stankewicz, D.O.
St. Luke's University Health Network


Backup Contact:

N/A


Location Contact:

Bethlehem, Pennsylvania 18015
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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