Human Laboratory Study of Smokeless Tobacco Products
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Withdrawal Severity
研究概览
简要总结
With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.
详细描述
Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
- •Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
- •Subjects will have used SLT for at least 1 year..
- •Subjects will be English speaking and reading.
- •Provide written informed consent.
排除标准
- •Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
- •Subjects who take medications that might affect the outcome of laboratory measures.
- •Subjects with a history of major mood, thought, anxiety or attentional disorders.
结局指标
主要结局
Withdrawal Severity
时间窗: Week 10
Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
次要结局
- Reinforcement(Week 10)
- Cognition Impairments(Week 10)
- Startle Response(Week 10)