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临床试验/NCT01250301
NCT01250301已完成不适用

Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes

Queen Mary University of London2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年7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
200
试验地点
2
主要终点
Urges to smoke in first week of abstinence

研究概览

简要总结

The aim of this study is to determine if using a behavioural replacement for smoking (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of abstinence. Two hundred smokers who want to quit will be recruited from the community. They would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy, Champix) and motivational support. On their target quit date, participants would be randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus standard treatment for the first two weeks of their quit attempt, or to continue with standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke at each week. Standard NHS SSS measures will also be taken in addition to user acceptability ratings and reactions to smoking cues.

The hypothesis is that complementing current NHS SSS treatments with de-nicotinised cigarettes, to address the non-nicotine factors associated with smoking and to help extinguish smoking behaviour, would result in lower urges to smoke than standard treatment alone.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or over
  • Seeking treatment to stop smoking

排除标准

  • Pregnant or breastfeeding
  • Acute psychiatric illness

结局指标

主要结局

Urges to smoke in first week of abstinence

时间窗: 1 week

Differences in urges to smoke in the first week of abstinence between participants who receive a behavioural replacement (DNCs) plus standard NHS SSS treatment, with those who receive standard NHS SSS treatment alone, will be measured by the Mood and Physical Symptoms Scale (MPSS; West \& Hajek, 2004).

次要结局

  • Change in ratings of tobacco withdrawal symptoms, measured by the MPSS(First 4 weeks of abstinence (from baseline- 4 weeks post-quit))
  • CO-validated continuous abstinence rates(4-weeks)
  • Acceptability and user reactions to DNCs(2 weeks)
  • Urges to smoke 24 hours after quitting, measured by the MPSS(24 hours)
  • Profile of adverse effects up to 12 weeks post quitting(12 weeks)
  • Reactions to smoking cues(12 weeks)

研究者

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

Hayden McRobbie

Dr. Hayden McRobbie

Queen Mary University of London

研究点 (2)

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