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临床试验/NCT02124200
NCT02124200已完成4 期

High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study

Universita degli Studi di Catania2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
2
主要终点
reducers

研究概览

简要总结

E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, 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 participants' opinions of these products 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

性别
All
接受健康志愿者

入选标准

  • Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

排除标准

  • history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (>140mmHg systolic and/or >90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

研究组 & 干预措施

EGO/CE4, 9mg nicotine

Other

干预措施: EGO/CE4, 9mg nicotine (Device)

结局指标

主要结局

reducers

时间窗: week-24 from baseline

sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers)

次要结局

  • heavy reducers and quitters(week-24 from baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Polosa

Full Professor of Internal Medicine

Universita degli Studi di Catania

研究点 (2)

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