Nicotine Pharmacokinetic Study and Volatile Organic Compound Analysis in Exhaled Breath After Electronic Cigarette Utilization.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Concentration of nicotine in blood at 40 min
研究概览
简要总结
Electronic or e-cigarettes are battery-powered devices that deliver vapor which may be inhaled in the manner tobacco is smoked. The e-liquid is usually a solution containing propylene glycol and/or vegetable glycerin, nicotine, and flavor concentrates, although some e-liquids also are sold as non-nicotine containing products. The long- and short-term public health consequences of e-cigarette use, including the effects of e-cigarettes on tobacco use behavior, are not well understood. However, the prevalence of e-cigarette use appears to be undergoing a rapid increase.
In this study the investigators propose to analyze nicotine pharmacokinetic in blood and to compare the exhaled breath before and after e-cigarette smoking. They want to obtain a pharmacokinetic model of this population for nicotine. And they want to identify if molecules contained in vapor are absorbed, metabolized or modified by the organism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who has already used electronic cigarette
- •Subject who has been using electronic cigarette for more than one month and/or Tobacco smoker (traditional cigarettes)
- •Subject without history of chronic pathology
- •Subject not taking long-term drug treatment
- •Subject able to understand studie's aims and risk
排除标准
- •Subject with a chronic respiratory pathology
- •Subject suffering from a respiratory or acute otorhinolaryngology pathology in progress or recent
- •Subject under alcohol withdrawal
- •Subject with heavy drinking or daily use of illegal drugs
- •Subject with epilepsy
- •Subject having hypersensitivity to one of the compounds of the spraying liquid
- •Subject with liver failure
- •Subject with severe renal impairment (GFR <60 ml / min)
- •Subject with an allergy to the molecules contained in the e-liquid
- •Subject suffering from claustrophobia
- •Pregnancy or breastfeeding
结局指标
主要结局
Concentration of nicotine in blood at 40 min
时间窗: At T40 min after the nicotine's absorption
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
Concentration of nicotine in blood at Baseline
时间窗: At T0 (during the nicotine's absorption by the patient)
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
Concentration of nicotine in blood at 10 minutes
时间窗: At T10 min after the nicotine's absorption
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
Concentration of nicotine in blood at 20 min
时间窗: At T20 min after the nicotine's absorption
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
Concentration of nicotine in blood at 80 min
时间窗: At T80 min after the nicotine's absorption
Concentration of nicotine in blood made by liquid chromatography/mass spectrometry method.
次要结局
未报告次要终点