The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes
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
- 是
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
Dunja Przulj
Prinicipal Investigator
Queen Mary University of London
