COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- High Ventilated Cigarette Purchases
研究概览
简要总结
Early attempts by the tobacco industry to develop "safer" cigarettes led to the widespread introduction of ventilation holes in cigarette filters; however, this design feature may instead increase smoking-related harm and make cigarettes more palatable. The overall goal of this project is to model regulatory restrictions banning cigarette filter ventilation and determine their effects on consumption of both cigarettes and a wide range of alternative tobacco products. Testing potential regulatory actions under controlled conditions will facilitate evidence-based policies that have a net benefit to health.
详细描述
Early attempts by the tobacco industry to develop "safer" cigarettes led to the widespread introduction of ventilation holes in cigarette filters; however, this design feature may instead increase smoking-related harm and make cigarettes more palatable. The overall goal of this project is to model regulatory restrictions banning cigarette filter ventilation and determine their effects on consumption of both cigarettes and a wide range of alternative tobacco products. Testing potential regulatory actions under controlled conditions will facilitate evidence-based policies that have a net benefit to health.
Detailed Description:
The duration of the experiment will be approximately 3 months. Participants will begin with an initial one week (approximately) exposure period to both unventilated and ventilated cigarettes as well as alternative nicotine products (e-cigarettes, snus, etc.) that will be made available throughout the experiment. Participants will be given the opportunity to sample both types of cigarettes and alternative nicotine products. In the following sessions, participants will alternate between Electronic Tobacco Marketplace (ETM) sessions and free exposure periods to their assigned cigarette, with weekly assessments throughout to track changes in smoking behavior and cigarette valuation. In total, participants will complete 10 experimental sessions (see Appendix B for experimental timeline figure). For the sake of clarity, session types are separated below. The consent and initial sessions may take place in the same or separate sessions.
At the beginning of the experiment, participants will be assigned to one of two groups: ventilated or unventilated. Group assignment will determine what cigarettes will be given to the participant after sessions in which they do not actually purchase their cigarettes of choice. Additionally, participants that typically smoke menthol cigarettes will be given a menthol version of their assigned cigarette. Cigarettes will be similar in design and will be labeled as Typa A or Type B.
At the initial session and throughout the study, urine samples may be collected and stored for testing (for tobacco use and pregnancy) and breath samples for carbon monoxide and alcohol. Self-report may be used in place of urine analyses on a case-by-case bases. Urine sample analyses for tobacco use may only take place at the VTCRI site.
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
- Single (Participant)
盲法说明
Participants will be randomly assigned to either ventilated or unventilated cigarettes and will not be informed of their group assignment.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current cigarette smoker
- •Stable mental and physical health
- •Does not take medications that interfere with nicotine metabolism
排除标准
- •Pregnant or lactating
- •Immediate future plans to quit smoking
结局指标
主要结局
High Ventilated Cigarette Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of their assigned cigarette increased progressively from $0.13 in the first trial to $4.00 in the final trial, while prices for other products (e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial were calculated for all prices and sessions 1, 2, and 3.
Low Ventilated Cigarette Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
E-Cigarette Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial for ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
E-liquid Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
Gum Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
Snus Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
Lozenge Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
Dip Purchases
时间窗: Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)
Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.
次要结局
未报告次要终点
研究者
Roberta Freitas-Lemos
Professor
Virginia Polytechnic Institute and State University