A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,510
- 试验地点
- 63
- 主要终点
- Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
研究概览
简要总结
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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 and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
- •Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) >10 ppm at screening.
- •Subjects with mild to moderate depression or anxiety may be included if their condition is stable.
排除标准
- •Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
- •Subjects with severe depression or anxiety.
- •Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
- •Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
研究组 & 干预措施
Varenicline Tartrate
干预措施: Varenicline Tartrate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
时间窗: Week 15 - 24
Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
次要结局
- Percentage of Participants With CO Confirmed 4-Week CA From Smoking(Week 21 - 24)
- Percentage of Participants With CO Confirmed Long Term CA From Smoking(Weeks 21 - 52)
- Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation(Week 12, 24, and 52)
- Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation(Week 52)