A Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and Biomarkers of Exposure in Adult Smokers Over a 12-week Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
研究概览
简要总结
To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.
详细描述
US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
- •Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
- •Interested in switching from combustible cigarettes to nicotine pouch products.
排除标准
- •Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
- •Participants who currently use nicotine pouches.
- •Participants with known heart disease or medical condition that may adversely affect participant safety
结局指标
主要结局
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
时间窗: Measured from baseline to week 12
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
次要结局
未报告次要终点