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Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

Primary Purpose

Prevention of Hangover Using N-Acety Cysteine

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine
placebo
Sponsored by
St. Luke's Hospital and Health Network, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Hangover Using N-Acety Cysteine focused on measuring hangovers, N-acetyl cysteine, alcohol

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • alcoholism (self-reported)
  • pregnancy
  • reactive airway disease
  • diabetes
  • kidney/bladder stones
  • kidney disease
  • liver disease
  • stomach ulcer
  • organ transplant patients
  • dialysis patients
  • allergies to alcohol, eggs, milk, or wheat
  • volunteers taking the following medications: opiate pain medication, activated charcoal, ampicillin,carbamazepine, cephalosporidine, methicillin, nitroglycerine, oxacillin, penicillin G, quinicillin

Sites / Locations

  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

N-acetyl cysteine

Arm Description

Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take placebo capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning

Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take N-Acetyl Cysteine capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 12, 2016
Last Updated
June 7, 2018
Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03104959
Brief Title
Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Official Title
Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
unable to enroll sufficient number of participants
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital and Health Network, Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Hangover Using N-Acety Cysteine
Keywords
hangovers, N-acetyl cysteine, alcohol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take placebo capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning
Arm Title
N-acetyl cysteine
Arm Type
Experimental
Arm Description
Healthy volunteers consume alcohol independently and estimate number of drinks then apply Vick's vapor rub under nose and take N-Acetyl Cysteine capsules based on number of drinks consumed and fill out a Hangover Symptom Scale the next morning
Intervention Type
Dietary Supplement
Intervention Name(s)
N-acetyl cysteine
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo
Time Frame
less than 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age over 21 years able and agrees to drink alcohol Exclusion Criteria: alcoholism (self-reported) pregnancy reactive airway disease diabetes kidney/bladder stones kidney disease liver disease stomach ulcer organ transplant patients dialysis patients allergies to alcohol, eggs, milk, or wheat volunteers taking the following medications: opiate pain medication, activated charcoal, ampicillin,carbamazepine, cephalosporidine, methicillin, nitroglycerine, oxacillin, penicillin G, quinicillin
Facility Information:
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15535450
Citation
Lieber CS. Relationships between nutrition, alcohol use, and liver disease. Alcohol Res Health. 2003;27(3):220-31.
Results Reference
background
PubMed Identifier
15706734
Citation
Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
Results Reference
background
PubMed Identifier
20463294
Citation
Gyamfi MA, Wan YJ. Pathogenesis of alcoholic liver disease: the role of nuclear receptors. Exp Biol Med (Maywood). 2010 May;235(5):547-60. doi: 10.1258/ebm.2009.009249.
Results Reference
background

Learn more about this trial

Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

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