NCT00717093已完成4 期
A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco
研究概览
简要总结
The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
- •Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
- •Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.
排除标准
- •Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
- •Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
- •Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
- •Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.
研究组 & 干预措施
Active
Experimental
干预措施: Varenicline Tartrate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco
时间窗: Weeks 9 through 12
Number of subjects who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine \<= 15 ng/mL.
次要结局
- Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use(Week 9 through 12, Week 26)
- Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco(Week 26)
- Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)(Week 12, Week 26)
研究者
研究点 (1)
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