Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in daily quantitative cigarette smoking
研究概览
简要总结
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Smoking 1 or more tobacco cigarettes per day.
- •Residence within reasonable driving distance to New Haven..
排除标准
- •Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
- •Unstable medical conditions requiring hospitalization.
- •Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
- •Unstable angina.
- •History of allergic reactions to adhesives.
- •Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
- •Current use of an electronic cigarette.
- •Subject unable or unwilling to complete study protocol for any reason.
研究组 & 干预措施
Non-nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
干预措施: Non-nicotine e-cigarette (Other)
Nicotine e-cigarette
Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
干预措施: Nicotine e-cigarette (Other)
结局指标
主要结局
Change in daily quantitative cigarette smoking
时间窗: baseline, 8 weeks, and 6 months.
Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up.
Change in exhaled carbon monoxide (CO) levels
时间窗: baseline, 8 weeks, and 6 months.
Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath.
次要结局
- Short-term impact on lung function (spirometry)(6 months)