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



Status:Terminated
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:6/13/2018
Start Date:January 2016
End Date:June 6, 2018

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Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

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.


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
We found this trial at
1
site
Bethlehem, Pennsylvania 18015
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Bethlehem, PA
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