Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 799
- 试验地点
- 6
- 主要终点
- Cigarettes Per Day (CPD)
研究概览
简要总结
This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.
详细描述
This randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money.
Subjects (N=200 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products.
Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial:
- Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking.
- Phase 2 - Marketplace Adaptation: Two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization;
- Phase 3 - Intervention: Randomization to a marketplace with access to either VLNC or NNC cigarettes plus non-combusted products for a 12 week period.
Biomarker samples are collected at baseline, end of Phase 2 and end of week Phase 3 (week 12).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female;
- •18/21 (legal age to purchase tobacco at site);
- •Biochemically confirmed smoker.
排除标准
- •Unstable health condition;
- •Unstable medications;
- •Pregnant or nursing.
研究组 & 干预措施
Very Low Nicotine Content Cigarettes
Very Low Nicotine Content Cigarettes (0.4 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes:
干预措施: Very Low Nicotine Content Cigarettes (Drug)
Normal Nicotine Content Cigarettes
Normal (Conventional) Nicotine Content (15.8 mg nicotine/g tobacco; 9 mg of tar): Median nicotine content, averaged across menthol and non-menthol cigarettes
干预措施: Normal Nicotine Content Cigarettes (Drug)
结局指标
主要结局
Cigarettes Per Day (CPD)
时间窗: 7 days prior to week 12 visit
The mean cigarettes (study and non-study cigarettes) smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).
Number of Smoke-free Days
时间窗: day 1 of study until day before week 12 visit
Rate of smoke-free days, defined as no cigarettes smoked in the past 24 hours calculated as the proportion of smoke-free days out of the total number of days in Phase 3. Number of smoke free days based on the interactive voice response (IVR)
次要结局
- Seven Day Point-prevalence CO-verified Abstinence(7 days before week 12 visit)
- Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA)(The last visit in Phase 2 is the end of the baseline)
- Study Cigarettes Per Day(12 weeks (Phase 3) on study cigarettes)