Extrait

Background and study aims Smokers find stopping difficult because when they try they suffer urges to smoke, which compel them to smoke again. Pharmacotherapy for smoking cessation reduces the intensity and frequency of these urges to smoke, but does not abolish them entirely and consequently most quitters will be back to smoking by the end of their treatment. Better treatments are therefore necessary. One possibility is wearing a nicotine patch prior to stopping smoking (preloading), and there is promising evidence that this would enhance success rates. The mechanism is not fully clear, but the most likely explanation relates to unlearning the learned association between smoking and pharmacological reward of cigarettes, principally derived from nicotine. There is good evidence that wearing a patch while smoking is safe and well tolerated and the MHRA have removed prohibitions on doing so. Therefore we aim to establish how well nicotine patch preloading works when combined with standard NHS smoking cessation treatment, in comparison to standard NHS treatment alone. Who can participate? Smokers who are willing to give up smoking in four weeks time, and are 18 years of age or older. Participants will be recruited through their GP practice or through their local NHS stop smoking service clinic. What does the study involve? We will provide smokers in the active treatment arm with 21mg nicotine patches for 4 weeks prior to quit day. We will advise people to smoke as often as normal while wearing the patch to undermine reward from 'forced' smoked cigarettes. They will also be referred for standard NHS stop smoking service treatment (which comprises behavioural support and pharmacotherapies). Participants in the control/coping arm will be provided with a minimal behavioural intervention aimed at identifying smoking cues and ways to deal with these after quit day, and will also be referred for standard NHS stop smoking service treatment. Follow-ups will take place 1 week, 4 weeks, 6 months and 12 months after each participant's quit day. The primary outcome will be six month validated prolonged abstinence. Additional abstinence outcomes will be 4 week and 12 month prolonged abstinence, and point prevalence 4 week, 6 month and 12 month abstinence. Markers of potential mediators, such as changes in carbon monoxide and cigarettes per day, aversion, dependence, smoking reward, urges to smoke, confidence in quitting and motivation to change will also be measured. A health economic analysis will be carried out. What are the possible benefits and risks of participating? By utilising standard NHS support for smoking cessation smokers can increase their chances of quitting smoking by four times more than when quitting alone, therefore we hope that taking part in the trial will benefit smokers by increasing their chances of success in quitting. There are no real risks of participation, however a minimal extra amount of time and effort may need to be put into participating in the trial in comparison to standard NHS treatment alone (due to the need to complete more questionnaires, and undertake additional clinic visits and follow-ups). Where is the study run from? All participants will be recruited within the UK, from one of the four research centres recruiting for the study (Birmingham, Bristol, London, Nottingham). Target recruitment is split equally between the four centres (approx 450 in each centre). Birmingham, Bristol and Nottingham will recruit through primary care practices and conduct clinic visits from these practices. London will recruit through and conduct clinics from an existing NHS smoking cessation service clinic. When is the study starting and how long is it expected to run for? Recruitment started in March 2012. Recruitment is planned over a period of 2 years. A futility analysis (to check whether the new treatment is likely to beat the control or not) will be conducted when all 6 month follow-up data has been collected. If an effect is apparent then the full 12 month follow-up will be completed, giving a full duration of 3.5 years. Who is funding the study? National Institute for Health Research (NIHR) Health Technology Assessment (HTA), UK. Who is the main contact? Dr Nicola Lindson [email protected]

Critère d'inclusion

• Tobacco smoking; smoking cessation; nicotine addiction

Liens

• isrctn
• ictrp