Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Aim 1: Average number of cigarettes smoked per day
研究概览
简要总结
The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.
详细描述
The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
To avoid randomized non-starters and potential bias due to differential early attrition from prior knowledge of group assignment, randomization will occur at the time of visit 0 when participants first receive tobacco products specific to their assigned condition, and neither the research assistant nor participant will know the assignment in advance. Researchers and participants will be blinded to the nicotine concentration.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21+ years old
- •English literate
- •Currently smoking cigarettes, biochemically confirmed
- •Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.
排除标准
- •Currently using any smoking cessation services and/or pharmacotherapies
- •Currently pregnant or breastfeeding
- •Significant current medical or psychiatric condition
- •Known hypersensitivity to propylene glycol.
结局指标
主要结局
Aim 1: Average number of cigarettes smoked per day
时间窗: From baseline to week 4
Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period for each product condition.
Aim 2: Percent of days using non-combustible product
时间窗: From baseline to week 4
Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method continuously over the 4-week observational period to determine the total percent days use of the non-combustible product for each product condition.
次要结局
- Aim 1: Percent of days abstinent from cigarettes(From baseline to week 4)
- Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes(Week 4)
- Aim 2: Average use of non-combustible products per day(From baseline to week 4)
- Aim 2: Continued use of non-combustible products(Week 4 to 6)
- Aim 1: Cigarette Dependence(From baseline to week 4)