Extended Varenicline for Smoking Cessation: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Smoking Behavior
研究概览
简要总结
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
详细描述
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •currently smoking at least 15 cigarettes daily
- •in good health
- •able to read and speak English fluently
- •have a home telephone and plan to reside in Western New York for 6 months
- •willing to make quit attempt
- •signed informed consent
- •who planned quit attempt.
排除标准
- •serious medical condition
- •depression or mental health condition requiring treatment in the past year
- •history of panic disorder, psychosis, bipolar disorder
- •alcohol or drug abuse in the past year
- •use of tobacco products other than cigarettes
- •current use of other cessation pharmacotherapies
- •pregnancy/planned pregnancy.
研究组 & 干预措施
varenicline
drug plus counseling.
干预措施: varenicline (Drug)
placebo
placebo plus counseling
干预措施: placebo (Drug)
结局指标
主要结局
Change in Smoking Behavior
时间窗: Change in cigarettes per day from Week 2 to Week 5
Change in cigarettes per day from Week 2 to Week 5
次要结局
- Rates of Smoking Cessation.(12 weeks after quit date.)