Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Average Nicotine Level
研究概览
简要总结
Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO > 8 ppm or NicAlert test of 6)
- •Engaging in relighting for at least half of their CPD
- •No smoking quit attempts in the past month nor intentions to quit in the next month
- •Stable medical or psychiatric conditions with systolic blood pressure < 160, diastolic blood pressure < 100 and heart rate < 105 bpm
排除标准
- •Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month
- •Currently trying or planning to quit smoking in the next month
- •Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.
研究组 & 干预措施
Continuous Smoking
During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the continuous smoking condition will crossover to the relight smoking condition after 60 minutes on their first visit.
Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection.
On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the continuous smoking condition will begin their second visit with the relighting smoking condition and cross over to the continuous smoking condition after the 60 minutes.
干预措施: Cigarettes (Other)
Relight Smoking
During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the relight smoking condition will crossover to the continuous smoking condition after 60 minutes on their first visit.
Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection.
On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the relighting smoking condition will begin their second visit with the continuous smoking condition and cross over to the relighting smoking condition after the 60 minutes.
干预措施: Cigarettes (Other)
结局指标
主要结局
Average Nicotine Level
时间窗: 1 month
Level of nicotine in cigarette butts collected during study.
次要结局
- Average Puff Volume(1 month)