Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cigarettes smoked over 24 hours
研究概览
简要总结
Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.
详细描述
Cigarette smoking remains the leading cause of preventable death and disease worldwide.
The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 year old
- •Meet DSM-IV criteria for nicotine dependence
- •Seeking treatment for smoking cessation
- •Smoking at least 15 cigarettes per day
- •Capable of giving informed consent and complying with study procedures
排除标准
- •Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
- •Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study
- •Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
- •Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
- •Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
- •Current DSM-IV diagnosis of substance dependence, other than nicotine
- •Use of cannabis or alcohol on more than 20 days in the past 30 days
- •Risk for suicide
研究组 & 干预措施
electronic cigarette
electronic cigarette 24mg cartridges; 1-2 cartridges daily
干预措施: electronic cigarette (Other)
nicotine inhaler
nicotine inhaler 10mg cartridge; max 16 cartridges daily
干预措施: nicotine inhaler (Drug)
结局指标
主要结局
Cigarettes smoked over 24 hours
时间窗: 4 weeks
次要结局
- Adverse reaction to nicotine inhaler or electronic cigarette(4 weeks)
- Symptoms of nicotine withdrawal(4 weeks)
- Benefits from smoking cessation(4 weeks)