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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC group | Active Comparator | Patients receiving NAC after drinking to breathalyzer value 0.1 |
|
| Placebo group | Placebo Comparator | Patients receiving placebo after drinking to breathalyzer value 0.1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N Acetyl Cysteine | Dietary Supplement |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hours or less |
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Inclusion Criteria:
Exclusion Criteria:
Volunteers taking the following medications will not be able to participate:
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| Name | Affiliation | Role |
|---|---|---|
| Holly A Stankewicz, D.O. | St. Luke's Hospital and Health Network, Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15706734 | Result | Swift R, Davidson D. Alcohol hangover: mechanisms and mediators. Alcohol Health Res World. 1998;22(1):54-60. | |
| 16373736 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | NAC First, Then Placebo | Patients receiving NAC after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received placebo then again completed the survey in the morning |
| FG001 | Placebo First Then NAC Group | Patients receiving placebo after drinking to breathalyzer value 0.1 and then completed the survey in the morning after drinking and then at a later date returned and drank again to BrAC level of 0.1 and received NAC then again completed the survey in the morning |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | units on a scale | 12 hours or less |
|
20 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAC Group | Patients receiving NAC after drinking to breathalyzer value 0.1 N Acetyl Cysteine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gas | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Stankewicz, D.O. | St. Luke's University Health Network | 610-360-2725 | holly.stankewicz@gmail.com |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Other |
|
| 10836917 | Result | 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. |
| 14506405 | Result | 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. |
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients receiving NAC after drinking to breathalyzer value 0.1 N Acetyl Cysteine |
| OG001 | Placebo Group | Patients receiving placebo after drinking to breathalyzer value 0.1 placebo |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 11 |
| 49 |
| EG001 | Placebo Group | Patients receiving placebo after drinking to breathalyzer value 0.1 placebo | 0 | 49 | 0 | 49 | 4 | 49 |
| insomnia | Nervous system disorders | Systematic Assessment |
|
| bloating | Gastrointestinal disorders | Systematic Assessment |
|
| acid reflux | Gastrointestinal disorders | Systematic Assessment |
|
| muscle twitches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |