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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

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.

Condition or disease Intervention/treatment Phase
Hangover Symptoms, NAC Dietary Supplement: N Acetyl Cysteine Other: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of NAC in Alleviation of Hangover Symptoms
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NAC group
Patients receiving NAC after drinking to breathalyzer value 0.1
Dietary Supplement: N Acetyl Cysteine
Other Name: NAC

Placebo Comparator: Placebo group
Patients receiving placebo after drinking to breathalyzer value 0.1
Other: placebo



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541422


Locations
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Investigators
Principal Investigator: Holly A Stankewicz, D.O. St. Luke's Hospital and Health Network, Pennsylvania

Publications of Results:
Responsible Party: Holly Stankewicz, D.O., Attending physician and faculty emergency medicine residency, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT02541422     History of Changes
Other Study ID Numbers: SLHN 2015-27
First Posted: September 4, 2015    Key Record Dates
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes