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临床试验/NCT01414998
NCT01414998已完成不适用

The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes

Queen Mary University of London2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Urge to smoke at 10 minutes post product use

研究概览

简要总结

There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.

Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.

Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).

The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or over
  • Smokes at least 10 cigarettes per day
  • Smokes first cigarette within 1 hour of waking

排除标准

  • pregnant or breastfeeding
  • acute psychiatric illness
  • currently enrolled in other research projects
  • current use of ECs or Denics

结局指标

主要结局

Urge to smoke at 10 minutes post product use

时间窗: 10 minutes

Urges to smoke will be measured at 10 minutes after use of products

次要结局

  • Tobacco withdrawal symptom ratings over 1 hour(1 hour)
  • Tobacco withdrawal symptom ratings over one day(1 day)

研究者

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

Dunja Przulj

Prinicipal Investigator

Queen Mary University of London

研究点 (2)

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