Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial.
Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-15-296
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发表时间：
2014-07-22
期刊：
影响因子：
2.5
通讯作者：
Aveyard P
中科院分区：
文献类型：
--
作者：
Lindson-Hawley N;Coleman T;Docherty G;Hajek P;Lewis S;Lycett D;McEwen A;McRobbie H;Munafò MR;Parrott S;Aveyard P
戒烟前使用尼古丁替代疗法称为尼古丁预负荷。标准戒烟方案建议仅在戒烟的第一天（戒烟日）开始尼古丁替代疗法，旨在减少戒断症状和渴望。然而，其他更成功的戒烟药物疗法在戒烟日之前和之后使用。尼古丁预负荷可以通过降低戒烟前吸烟的满意度和打破吸烟与奖励之间的联系来提高戒烟率。系统的文献综述表明，预加载的有效性的证据是不确定的，需要进一步的试验。这是一项多中心、非盲、随机对照试验的研究方案，该试验在英国进行，招募了1786名希望戒烟的吸烟者，由国家健康研究所、健康技术评估项目资助，并由牛津大学赞助。参与者将主要通过全科诊所和戒烟诊所招募，并随机（1：1）在戒烟前四周使用或不使用21 mg尼古丁贴片，同时正常吸烟。所有参与者将被转介接受标准戒烟服务支持。随访将在戒烟后1周、4周、6个月和12个月进行。主要结果将是延长，生化验证六个月的禁欲。其他结果将包括点患病率禁欲和禁欲的4周和12个月的持续时间，副作用，治疗费用，和标志物的潜在介质和调节剂的预负荷效应。这项大型试验将大大增加尼古丁预负荷有效性的证据，同时也增加了其成本效益和潜在介质的证据，这些证据以前没有详细研究过。已经考虑了一系列征聘战略，以努力弥补在征聘大量样本时遇到的任何挑战，多中心设计意味着征聘小组之间可以分享知识。务实的研究设计意味着，如果将其作为标准戒烟服务实践的一部分推出，结果将对干预的成功进行现实的估计。当前对照试验ISRCTN33031001。2012年4月27日注册。
The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice. Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
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影响因子：
3.4
作者：
Gwaltney, Chad J.;Metrik, Jane;Kahler, Christopher W.;Shiffman, Saul
通讯作者：
Shiffman, Saul
影响因子：
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作者：
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通讯作者：
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影响因子：
4.7
作者：
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通讯作者：
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