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Clinical Trials/NCT03104959
NCT03104959
Terminated
Not Applicable

Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

St. Luke's Hospital and Health Network, Pennsylvania1 site in 1 country200 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of Hangover Using N-Acety Cysteine
Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
Enrollment
200
Locations
1
Primary Endpoint
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms 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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
June 6, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
Responsible Party
Principal Investigator
Principal Investigator

Holly Stankewicz, D.O.

attending physician and faculty emergency medicine residency

St. Luke's Hospital and Health Network, Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • age over 21 years
  • able and agrees to drink alcohol

Exclusion Criteria

  • alcoholism (self-reported)
  • pregnancy
  • reactive airway disease
  • kidney/bladder stones
  • kidney disease
  • liver disease
  • stomach ulcer
  • organ transplant patients
  • dialysis patients
  • allergies to alcohol, eggs, milk, or wheat

Outcomes

Primary Outcomes

Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo

Time Frame: less than 24 hours

Study Sites (1)

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