Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 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
- 是
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.
研究组 & 干预措施
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: NNC Spectrum Cigarette (Other)
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Moderate nicotine level e-liquid (Other)
Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Tobacco Flavors (Other)
NNC cigarette + low nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: NNC Spectrum Cigarette (Other)
NNC cigarette + low nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Low nicotine level e-liquid (Other)
NNC cigarette + low nicotine e-liquid + tobacco flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Tobacco Flavors (Other)
NNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: NNC Spectrum Cigarette (Other)
NNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: Moderate nicotine level e-liquid (Other)
NNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: Tobacco and non-tobacco e-liquid flavors (Other)
NNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: NNC Spectrum Cigarette (Other)
NNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: Low nicotine level e-liquid (Other)
NNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: Tobacco and non-tobacco e-liquid flavors (Other)
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: VLNC Spectrum Cigarette (Other)
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Moderate nicotine level e-liquid (Other)
Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Tobacco Flavors (Other)
VLNC cigarette + low nicotine e-liquid +tobacco flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: VLNC Spectrum Cigarette (Other)
VLNC cigarette + low nicotine e-liquid +tobacco flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Low nicotine level e-liquid (Other)
VLNC cigarette + low nicotine e-liquid +tobacco flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.
干预措施: Tobacco Flavors (Other)
VLNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: VLNC Spectrum Cigarette (Other)
VLNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: Moderate nicotine level e-liquid (Other)
VLNC cigarette + moderate nicotine e-liquid + variety flavors
Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.
干预措施: Tobacco and non-tobacco e-liquid flavors (Other)
VLNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: VLNC Spectrum Cigarette (Other)
VLNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: Low nicotine level e-liquid (Other)
VLNC cigarette + low nicotine e-liquid + variety flavors
Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors
干预措施: Tobacco and non-tobacco e-liquid flavors (Other)
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)