NCT00770666已完成4 期
Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Tobacco use abstinence
研究概览
简要总结
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
详细描述
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).
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
- 否
入选标准
- •currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
- •18 years or older
- •interested in quitting within the next 30 days
- •one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)
排除标准
- •contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
- •current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
- •unable to give consent
研究组 & 干预措施
1
Experimental
Nicotine patch, nicotine inhaler, bupropion
干预措施: Nicotine patch, nicotine inhaler, bupropion (Drug)
2
Active Comparator
Nicotine patch
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Tobacco use abstinence
时间窗: 26 week
次要结局
- Time to first relapse(varies)
- Adverse clinical events(26 weeks)
- Duration of medication use(26 weeks)
研究者
研究点 (1)
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