Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 4
- 主要终点
- Quit Rate
研究概览
简要总结
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be at least 18 years of age
- •Be in good general health
- •Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
- •Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
- •Subjects must be motivated to quite smoking
- •If female and of child bearing potential, agrees to use birth control and subject
- •Subject must be able to understand and provide written informed consent.
- •Please contact site for more information
排除标准
- 未提供
研究组 & 干预措施
Selegiline Transdermal Patch
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
干预措施: Selegiline Transdermal Patch (Drug)
Selegiline Transdermal Patch
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
干预措施: Smoking Cessation Counseling (Behavioral)
Placebo
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
干预措施: Placebo (Drug)
Placebo
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
干预措施: Smoking Cessation Counseling (Behavioral)
结局指标
主要结局
Quit Rate
时间窗: Study weeks 6 through 9
The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
次要结局
- Abstinence(week 14)