Clinical trial NCT02541422: Use of NAC in Alleviation of Hangover Symptoms
Official title: Use of NAC in Alleviation of Hangover Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hangover Symptoms, NAC
Lead sponsor: St. Luke's Hospital and Health Network, Pennsylvania
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Hangover Symptom Scale
timeFrame: 12 hours or less
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Holly A Stankewicz, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60.
citation: 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.
citation: 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.
citation: 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.