NCT00018148已完成2 期
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Validated smoking cessation
研究概览
简要总结
Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70,
- •smoking > 10 cigarettes per day,
- •no current major depression,
- •no concurrent psychiatric medications
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Transdermal nicotine plus nortriptyline
干预措施: nortriptyline (Drug)
2
Active Comparator
Transdermal nicotine plus placebo
干预措施: transdermal nicotine (Drug)
结局指标
主要结局
Validated smoking cessation
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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