A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,236
- 试验地点
- 2
- 主要终点
- Quit Attempts and Abstinence
研究概览
简要总结
This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.
Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=19
- •a daily cigarette smoker of >=10 cigs/day
- •English speaking
- •live in the contiguous U.S.
- •unmotivated to quit smoking in the next 30 days
排除标准
- •no use of smokeless tobacco in past six months
- •not breastfeeding, pregnant, or planning a pregnancy
- •devoid of any recent (past 6 months) cardiovascular trauma
- •no quit attempt of >=1 week in past 6 months
- •no use of pharmacotherapy to quit smoking in past 3 months
结局指标
主要结局
Quit Attempts and Abstinence
时间窗: From study enrollment through end of one-year follow up
% of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence
次要结局
未报告次要终点