Long-term Varenicline Treatment for Smoking Cessation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
研究概览
简要总结
This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •daily smoker
- •5+ cigarettes per day for at least one year
- •expired carbon monoxide level of 5+ ppm
排除标准
- •current use of smoking cessation pharmacotherapies
- •current or history of psychotic disorder
- •current major depressive disorder
- •history of suicidal ideation in the previous 3 months
- •unstable medical condition
- •pregnant, nursing, or planning to become pregnant
- •planning to move from study area within 18 months
研究组 & 干预措施
Extended treatment
52-week varenicline therapy + individual smoking cessation counseling
干预措施: varenicline (Drug)
Extended treatment
52-week varenicline therapy + individual smoking cessation counseling
干预措施: Individual smoking cessation counseling (Behavioral)
Standard treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
干预措施: varenicline (Drug)
Standard treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
干预措施: Individual smoking cessation counseling (Behavioral)
结局指标
主要结局
Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
时间窗: 7-day point prevalence
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52
次要结局
未报告次要终点