Use of NAC in Alleviation of Hangover Symptoms

NCT02541422 | Completed Results

• 1 other identifier: SLHN 2015-27
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hangover Symptoms, NAC

Outcome Measures

Primary Outcomes (1)

• Hangover Symptom Scale

  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.

  12 hours or less

Study Arms (2)

NAC group

ACTIVE COMPARATOR

Patients receiving NAC after drinking to breathalyzer value 0.1

Dietary Supplement: N Acetyl Cysteine

Placebo group

PLACEBO COMPARATOR

Patients receiving placebo after drinking to breathalyzer value 0.1

Other: placebo

Interventions

N Acetyl Cysteine DIETARY_SUPPLEMENT

Also known as: NAC

NAC group

placebo OTHER

Placebo group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers over age 21 years

You may not qualify if:

• 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,

Sponsors & Collaborators

• St. Luke's Hospital and Health Network, Pennsylvania: lead

Study Sites (1)

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Related Publications (4)

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

  PMID: 15706734 RESULT

• 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. doi: 10.1136/bmj.331.7531.1515.

  PMID: 16373736 RESULT

• Wiese JG, Shlipak MG, Browner WS. The alcohol hangover. Ann Intern Med. 2000 Jun 6;132(11):897-902. doi: 10.7326/0003-4819-132-11-200006060-00008.

  PMID: 10836917 RESULT

• 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. doi: 10.1097/01.ALC.0000085585.81711.AE.

  PMID: 14506405 RESULT

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Holly Stankewicz, D.O.
• Organization: St. Luke's University Health Network

holly.stankewicz@gmail.com

610-360-2725

Study Officials

• Holly A Stankewicz, D.O.

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician and faculty emergency medicine residency

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2017-09

Locations

US (1)