Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
研究概览
简要总结
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.
This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.
详细描述
Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated.
In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •healthy smokers
- •unwilling to quit
- •age 18-60 years
- •smoking ≥ 15 cig/day for at least 5 years
- •exhaled CO level of ≥ 15 ppm
排除标准
- •alcohol and illicit drug use
- •breastfeeding or pregnancy
- •major depression or other psychiatric conditions
- •previous experience with ENDD
- •recent myocardial infarction
- •angina pectoris
- •high blood pressure (BP>140mm Hg systolic and/or 90mmHg diastolic)
- •diabetes mellitus
- •severe allergies
- •poorly controlled asthma or other airways diseases
结局指标
主要结局
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
时间窗: number of cigarettes/day as assessed at week 24
Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).
次要结局
- Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)(number of cigarettes/day as assessed at week 24)
研究者
Riccardo Polosa
Professor of Internal Medicine
Universita degli Studi di Catania