跳至主要内容
临床试验/NCT02398487
NCT02398487已完成不适用

Head-To-Head Comparision of Personal Vaporizers Versus Cigalike: Prospective 6-Month Randomized Control Design Study

Universita degli Studi di Catania2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年10月最近更新:
适应症
干预措施

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

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

No Intervention

Personal Vaporizer

Active Comparator

Personal Vaporizer loaded with nicotine

干预措施: Personal Vaporizer with nicotine (Device)

Cigalike

Active Comparator

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

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

Riccardo Polosa

Professor

Universita degli Studi di Catania

研究点 (2)

Loading locations...

相似试验