Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Number of Days Using Alternative Products
研究概览
简要总结
The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.
详细描述
This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.
Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
- •No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
- •Subject has provided written informed consent to participate in the study
排除标准
- •Regular use of tobacco products (including e-cigarettes) other than cigarettes
- •Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
- •Pregnant or breastfeeding (due to toxic effects from tobacco products).
- •Planned quit date within the next two months.
- •Does not have a way that the research team can communicate with them by phone or e-mail.
- •Not able to read and write English well enough to complete study activities without translation.
结局指标
主要结局
Number of Days Using Alternative Products
时间窗: 8 week intervetnion period
The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Number of Combusted Products Smoked
时间窗: At weeks 6-8 (last two weeks of intervention period)
Number of combusted products smoked per day during the last two weeks of the intervention period.
次要结局
- Rate of 24 Hour Quit Attempts(8 week intervention period)
- Carcinogen Exposure Biomarker: Total NNAL(Week 8 (end of intervention))