Use of NAC in Alleviation of Hangover Symptoms

• 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: St. Luke's Hospital and Health Network, Pennsylvania
• Information provided by (Responsible Party): Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications of Results:

Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60. Review.

Pittler MH, Verster JC, Ernst E. Interventions for preventing or treating alcohol hangover: systematic review of randomised controlled trials. BMJ. 2005 Dec 24;331(7531):1515-8. Review.

Wiese JG, Shlipak MG, Browner WS. The alcohol hangover. Ann Intern Med. 2000 Jun 6;132(11):897-902. Review.

Slutske WS, Piasecki TM, Hunt-Carter EE. Development and initial validation of the Hangover Symptoms Scale: prevalence and correlates of Hangover Symptoms in college students. Alcohol Clin Exp Res. 2003 Sep;27(9):1442-50.

• 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
• Other Study ID Numbers: SLHN 2015-27
• First Posted: September 4, 2015
• 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