The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes in cigarettes per day
研究概览
简要总结
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
- •usual brand (the brand used most often) is mentholated
- •have a smartphone that can receive text messages and access the internet (necessary for diary completion).
排除标准
- •other tobacco and pharmacotherapy criteria
- •health and safety criteria
- •planning to move out of the area within the next 3 months
研究组 & 干预措施
Menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Menthol Flavored E-cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Menthol Cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Tobacco Flavored E-cigarettes (Behavioral)
Menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Non-Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Menthol Flavored E-cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Non-Menthol Cigarettes (Behavioral)
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes
Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
干预措施: Tobacco Flavored E-cigarettes (Behavioral)
结局指标
主要结局
Changes in cigarettes per day
时间窗: Week 1- Week 6
Will be measured through week 6 of the study
次要结局
- Fagerstrom Test for Nicotine Dependence(Week 1- Week 7)
- Ability to abstain from smoking(Week 7)
研究者
Tracy Smith
Associate Professor-Faculty
Medical University of South Carolina