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

NCT03104959 | Terminated

• 1 other identifier: SLUHN2015-105
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Hangover Using N-Acety Cysteine

Keywords

hangovers; N-acetyl cysteine; alcohol

Outcome Measures

Primary Outcomes (1)

• Degree of hangover improvement as measured by hangover symptoms scale after using N-acetyl cysteine compared to placebo

  less than 24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

N-acetyl cysteine

EXPERIMENTAL

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

Interventions

N-acetyl cysteine DIETARY_SUPPLEMENT

N-acetyl cysteine

placebo OTHER

Placebo

Eligibility Criteria

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

You may qualify if:

• age over 21 years
• able and agrees to drink alcohol

You may not qualify if:

• 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

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 (3)

• Lieber CS. Relationships between nutrition, alcohol use, and liver disease. Alcohol Res Health. 2003;27(3):220-31.

  PMID: 15535450 BACKGROUND

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

  PMID: 15706734 BACKGROUND

• Gyamfi MA, Wan YJ. Pathogenesis of alcoholic liver disease: the role of nuclear receptors. Exp Biol Med (Maywood). 2010 May;235(5):547-60. doi: 10.1258/ebm.2009.009249.

  PMID: 20463294 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician and faculty emergency medicine residency

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: April 7, 2017
• Study Start: January 1, 2016
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

US (1)