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Trial record 2 of 3 for:    nac hangover

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

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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

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.

Condition or disease Intervention/treatment Phase
Prevention of Hangover Using N-Acety Cysteine Dietary Supplement: N-acetyl cysteine Other: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Study Start Date : January 2016
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : June 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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
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
Dietary Supplement: N-acetyl cysteine



Primary Outcome Measures :
  1. Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo [ Time Frame: less than 24 hours ]


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:

  • 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

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): NCT03104959


Locations
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania

Publications:
Responsible Party: Holly Stankewicz, D.O., attending physician and faculty emergency medicine residency, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT03104959     History of Changes
Other Study ID Numbers: SLUHN2015-105
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Keywords provided by Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania:
hangovers
N-acetyl cysteine
alcohol

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiviral Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes