e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sustained Abstinence
研究概览
简要总结
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokes at least five cigarettes per day
- •No current or previous regular use of e-cigarettes
- •Ready to quit smoking
排除标准
- •Use of smokeless or pipe tobacco
- •Smoke more than 40 cigarettes per day
- •Pregnant or breastfeeding
- •Unable to chew gum due to dental or jaw problems
- •Myocardial infarction (heart attack) within the previous 12 months
- •Hypersensitivity to propylene glycol or nicotine gum
研究组 & 干预措施
e-Cigarette
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
干预措施: STAM 1100mAh CE4 eGo Clearomizer (Other)
Nicotine polacrilex
Nicotine Replacement gum
干预措施: Nicotine polacrilex (Drug)
结局指标
主要结局
Sustained Abstinence
时间窗: 12 weeks
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
次要结局
- Point Prevalence Abstinence(12 weeks)