In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- In-vivo extraction of cadmium
研究概览
简要总结
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
详细描述
Comparisons:
A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.
D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •non-smokers, 18 to 50 years of age.
- •Habitual use of > 7 portions snus daily since minimum 1 year.
- •Healthy according to the health declaration and interview.
- •Written informed consent given.
排除标准
- •Concurrent participation in another clinical trial.
- •History of allergy.
- •History of allergy.
结局指标
主要结局
In-vivo extraction of cadmium
时间窗: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount
次要结局
- in-vivo extraction of tobacco specific nitrosamines (TSNAs)
- In-vivo extraction of lead(30 minutes' use)
- In-vivo extraction of nicotine(30 minutes' use)