NCT00840242已完成3 期
Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
研究概览
简要总结
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
详细描述
To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction
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
- Double (Participant, Investigator)
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
- •Age above 18
- •Smoking >/= 15 cigarettes/day
- •Having smoked for 3 years or more
- •CO >/= 10ppm at inclusion
- •Want to reduce smoking
- •Prepared to adhere to the protocol
- •Willing to provide signed informed consent
- •Having made at least one serious attempt to quit smoking
排除标准
- •Unstable angina pectoris, myocardial infarction within the last three months
- •Use of other nicotine-containing products such as cigars, pipes, snuff
- •Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
- •Pregnancy/lactation or intended pregnancy
- •Under psychiatric care or medication that might interfere with the trial
- •Abuse of alcohol or any other drug
研究组 & 干预措施
Nicotine gum
Experimental
Nicotine gum
干预措施: Nicotine gum (Drug)
Placebo gum
Placebo Comparator
Placebo gum
干预措施: Placebo gum (Drug)
Nicotine inhaler
Active Comparator
Nicotine inhaler
干预措施: Nicotine inhaler (Drug)
Placebo inhaler
Placebo Comparator
Placebo inhaler
干预措施: Placebo inhaler (Drug)
结局指标
主要结局
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
时间窗: Baseline to 6 weeks, 3 and 4 months
次要结局
- Changes in laboratory values of cardiovascular risk factors(Baseline up to 12 months)
- Changes in clinical and laboratory exposure parameters(Baseline up to 12 months)
研究者
研究点 (2)
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