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Trial record 1 of 3 for:    acetylcysteine hangover
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Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104959
Recruitment Status : Terminated (unable to enroll sufficient number of participants)
First Posted : April 7, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date June 11, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2017)
Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo [ Time Frame: less than 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Official Title  ICMJE Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Hangover Using N-Acety Cysteine
Intervention  ICMJE
  • Dietary Supplement: N-acetyl cysteine
  • Other: placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    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
    Intervention: Other: placebo
  • Experimental: N-acetyl cysteine
    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: Dietary Supplement: N-acetyl cysteine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: April 1, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 6, 2018
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03104959
Other Study ID Numbers  ICMJE SLUHN2015-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
Study Sponsor  ICMJE St. Luke's Hospital and Health Network, Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Luke's Hospital and Health Network, Pennsylvania
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP