Head-To-Head Comparision of Personal Vaporizers Versus Cigalike: Prospective 6-Month Randomized Control Design Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Smoking Reduction
研究概览
简要总结
This is a pilot study to compare efficiency and tolerability of a personal vaporizers (PV) new generation electronic cigarette loaded with nicotine e-liquid with cigalike new generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of well characterized regular smokers unwilling to quit.
详细描述
RATIONALE
The results of ECLAT - the first randomized controlled trial addressing the impact of electronic cigarette use in relation to smoking reduction, smoking abstinence and safety long-term - have revealed important and persistent modifications in the smoking habits of 300 smokers (not intending to quit) with significant reduction in tobacco cigarettes' consumption (1).
Surprisingly, the reduction in cig/day use in ECLAT was not much different among study groups, with the non-nicotine study group performing much like both high and low nicotine study groups. This was because, with the products used in ECLAT, saliva cotinine levels were well below the concentration threshold considered to be representative for regular smokers (2) or experienced electronic cigarette users (3) in both high and low nicotine study groups. Specifically, the model under investigation in ECLAT is not very efficient at delivering nicotine (4).
With this in mind, we have designed a pilot study to compare efficiency and tolerability of a personal vaporizers (PV) new generation electronic cigarette loaded with nicotine e-liquid with cigalike new generation electronic cigarette loaded with nicotine and usual smoking habits, in a group of well characterized regular smokers unwilling to quit.
STUDY OBJECTIVES
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in good general health
- •committed to follow the trial procedures
- •Exclusion Criteria
- •recent vaping history (stopped vaping less than 3 months ago)
- •use of any other form of non combustible nicotine containing products (chewable tobacco or nicotine replacement therapy) symptomatic cardiovascular disease
- •clinical history of asthma and chronic obstructive pulmonary disease (COPD)
- •regular psychotropic medication use
- •current or past history of alcohol abuse
- •use of smokeless tobacco or nicotine replacement therapy, and pregnancy or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Usual smoking
Personal Vaporizer
Personal Vaporizer loaded with nicotine
干预措施: Personal Vaporizer with nicotine (Device)
Cigalike
Cigalike loaded with nicotine
干预措施: cigalike with nicotine (Device)
结局指标
主要结局
Smoking Reduction
时间窗: 24 week
50% reduction of cigarette smoked compared to baseline
次要结局
- Smoking Cessation(24 week)
研究者
Riccardo Polosa
Professor
Universita degli Studi di Catania
