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

St. Luke's Hospital and Health Network

Status: Terminated

Conditions: Prevention of Hangover Using N-Acety Cysteine

Treatments: Other: placebo; Dietary Supplement: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT03104959

SLUHN2015-105

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

N-acetyl cysteine

Experimental group

Description:

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

Treatment:

Dietary Supplement: N-acetyl cysteine