Gradual vs. Abrupt Cessation Treatment for Smoking
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
研究概览
简要总结
This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.
详细描述
For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the next 30 days to one of three groups: gradual reduction, abrupt cessation, and minimal intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Interested in quitting gradually
- •At least 18 years old
- •Daily cigarette smoker
- •Smoke at least 15 cigarettes per day (CPD)
- •No change greater than 20% in CPD in the last month
- •Interested in quitting in next 30 days
- •Must agree to not use non-cigarette tobacco during study
- •No use of smoking cessation medication in last month
- •Have phone with voice mail
- •Willing to use nicotine lozenge
- •No other person in household in study
- •Fluent/literate in English
排除标准
- •Women who are pregnant or breastfeeding
- •Currently using medication for depression or asthma
- •Heart disease requiring medication
- •Heart attack in last month
- •Irregular heartbeat
- •High blood pressure not controlled by medication
- •Stomach ulcers
研究组 & 干预措施
Gradual reduction
Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Reduction Phone Counseling (Behavioral)
Gradual reduction
Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Pre-Quit Nicotine Lozenges (Drug)
Gradual reduction
Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Post-Quit Nicotine Lozenges (Drug)
Abrupt cessation
Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Abrupt Phone Counseling (Behavioral)
Abrupt cessation
Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Post-Quit Nicotine Lozenges (Drug)
Minimal intervention
Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Minimal Abrupt Phone Counseling (Behavioral)
Minimal intervention
Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
干预措施: Post-Quit Nicotine Lozenges (Drug)
结局指标
主要结局
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
时间窗: 6 months
Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million
次要结局
未报告次要终点
研究者
John Hughes
Professor of Psychiatry
University of Vermont