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临床试验/NCT02541422
NCT02541422已完成不适用

Use of NAC in Alleviation of Hangover Symptoms

St. Luke's Hospital and Health Network, Pennsylvania2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Hangover Symptom Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers over age 21 years

排除标准

  • 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.

研究组 & 干预措施

NAC group

Active Comparator

Patients receiving NAC after drinking to breathalyzer value 0.1

干预措施: N Acetyl Cysteine (Dietary Supplement)

Placebo group

Placebo Comparator

Patients receiving placebo after drinking to breathalyzer value 0.1

干预措施: placebo (Other)

结局指标

主要结局

Hangover Symptom Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
St. Luke's Hospital and Health Network, Pennsylvania
申办方类型
Other
责任方
Principal Investigator
主要研究者

Holly Stankewicz, D.O.

Attending physician and faculty emergency medicine residency

St. Luke's Hospital and Health Network, Pennsylvania

研究点 (2)

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