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临床试验/NCT03185546
NCT03185546已完成不适用

Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior

Wake Forest University Health Sciences4 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
4
主要终点
Total Cigarettes Smoked Per Day

研究概览

简要总结

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Smokers who have tried vaping multiple times.
  • Generally good health.

排除标准

  • If female, currently pregnant, trying to become pregnant or breastfeeding.
  • Planning to quit smoking.

结局指标

主要结局

Total Cigarettes Smoked Per Day

时间窗: Week 10 through Week 12

The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).

次要结局

  • Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)(Baseline - Week 12)
  • Number of Subjects With Smoke Free Days(Baseline-Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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