A Double Blind, Randomised, Placebo-controlled, Within-subject Crossover Study to Examine the Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in breath alcohol concentration
研究概览
简要总结
The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.
详细描述
In each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. The effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 26 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Able and willing to comply with the requirements of the study, confirmed by written informed consent
- •Aged 20 to 26 years
- •Within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2)
- •At least 12-14 years of formal education
- •In good general health as determined by medical history and screening investigations (see below)
- •Taking no regular medication
- •No history of psychiatric disorders
- •Moderate alcohol consumption (less than 190.4 g/week) according to the Daily Drink questionnaire (Collins et a., 1985)
- •"sporadic" users of Energy Drinks (fewer than 10 cans of 250 ml in the last 6 months)
- •Confirmation that the general practitioner/primary care physician knows no reason that would prevent their participation
- •Similar in social and demographic data, similar quality of life
- •similar patterns of use of alcoholic beverages and Energy Drinks as well as quality of life (Martinez et al., 2000)
- •similar level of physical activity (physical activity questionnaire) (Baecke et al., 1982)
排除标准
- •Any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data
- •Consumed 2>x>4 caffeine-containing drinks/day within 3 months of screening
- •Smoked >10 cigarettes/day or equivalent within 3 months of screening
- •Consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or
- •Consumed less than one alcoholic drink per week
研究组 & 干预措施
Placebo
干预措施: Placebo (without alcohol, caffeine, energy drink) (Drug)
Comparator 1 (with alcohol)
干预措施: Comparator 1 (with alcohol; without caffeine and energy drink) (Drug)
Comparator 2 (with alcohol and coffeine)
干预措施: Comparator 2 (with alcohol and caffeine; without energy drink) (Drug)
Comparator 3 (with alcohol and energy drink)
干预措施: Comparator 3 (with alcohol and energy drink) (Drug)
结局指标
主要结局
Changes in breath alcohol concentration
时间窗: from baseline up to 150 minutes
Changes of subjective effects of intoxication
时间窗: from baseline up to 120 minutes
次要结局
- Safety and tolerability(participants will be followed for the whole testing period of an expected average of 5 hours)
- Changes in Supine and standing vital signs(from baseline up to 150 minutes)