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Use of NAC in Alleviation of Hangover Symptoms

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ClinicalTrials.gov Identifier: NCT02541422
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : May 30, 2018
Last Update Posted : May 30, 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 September 1, 2015
First Posted Date  ICMJE September 4, 2015
Results First Submitted Date  ICMJE July 1, 2017
Results First Posted Date  ICMJE May 30, 2018
Last Update Posted Date May 30, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
Hangover Symptom Scale [ Time Frame: 12 hours or less ]
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. 0 representing "strongly disagree" or "feels like I did not drink last night" to 4 representing "strongly agree" or "I'm so hungover / I'm never drinking again" for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking. The total score could range from 0-52 with 0 being no symptoms of hangover and 52 being the worst symptoms of hangover. This study looked specifically at the overall hangover score, nauseated, feeling weak and headache.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
Hangover Symptom Scale [ Time Frame: 12 hours or less ]
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. 0 representing "strongly disagree" or "feels like I did not drink last night" to 4 representing "strongly agree" or "I'm so hungover / I'm never drinking again" for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking.
Change History Complete list of historical versions of study NCT02541422 on ClinicalTrials.gov Archive Site
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 Alleviation of Hangover Symptoms
Official Title  ICMJE Use of NAC in Alleviation of Hangover Symptoms
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hangover Symptoms, NAC
Intervention  ICMJE
  • Dietary Supplement: N Acetyl Cysteine
    Other Name: NAC
  • Other: placebo
Study Arms  ICMJE
  • Active Comparator: NAC group
    Patients receiving NAC after drinking to breathalyzer value 0.1
    Intervention: Dietary Supplement: N Acetyl Cysteine
  • Placebo Comparator: Placebo group
    Patients receiving placebo after drinking to breathalyzer value 0.1
    Intervention: Other: placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2015)
50
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT02541422
Other Study ID Numbers  ICMJE SLHN 2015-27
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
Principal Investigator: Holly A Stankewicz, D.O. St. Luke's Hospital and Health Network, Pennsylvania
PRS Account St. Luke's Hospital and Health Network, Pennsylvania
Verification Date September 2017

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