Hangover Symptoms, NAC
Conditions
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.
Interventions
DIETARY_SUPPLEMENTN Acetyl Cysteine
OTHERplacebo
Sponsors
St. Luke's Hospital and Health Network, Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hangover Symptom Scale | 12 hours or less | 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. |
Countries
United States
Participant flow
Pre-assignment details
62 people were enrolled however only 49 were included in the analysis due to not submitting their surveys or did not complete the first day of the study.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants received the 2 interventions - NAC and placebo. The participants completed one intervention on one day and returned to complete the other intervention on a subsequent day. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 49 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 49 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 11 / 49 | 4 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
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.
Time frame: 12 hours or less
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NAC Group | Hangover Symptom Scale | total Hangover symptom score | 10 units on a scale |
| NAC Group | Hangover Symptom Scale | headache | 1 units on a scale |
| NAC Group | Hangover Symptom Scale | nauseated | 0 units on a scale |
| NAC Group | Hangover Symptom Scale | feeling weak | 1 units on a scale |
| Placebo Group | Hangover Symptom Scale | feeling weak | 1 units on a scale |
| Placebo Group | Hangover Symptom Scale | total Hangover symptom score | 13 units on a scale |
| Placebo Group | Hangover Symptom Scale | nauseated | 1 units on a scale |
| Placebo Group | Hangover Symptom Scale | headache | 1 units on a scale |
p-value: 0.45Wilcoxon (Mann-Whitney)
p-value: 0.93Wilcoxon (Mann-Whitney)
p-value: 0.11Wilcoxon (Mann-Whitney)
p-value: 0.72Wilcoxon (Mann-Whitney)