Smokers in England are being asked to wear nicotine patches for four weeks before they quit, while still smoking, to see if this makes it easier to stop for good. Standard NHS advice tells smokers not to use nicotine replacement therapy (NRT) while they are still lighting up. This trial challenges that rule. The idea is that pre-loading with patches could break the link between smoking and everyday triggers, get smokers used to NRT, or even make cigarettes less appealing. Previous evidence has been inconclusive, so this large, pragmatic trial aims to settle the question. If pre-loading works, it would change how stop-smoking services operate across the NHS. The intervention is cheap and simple—a patch worn before quit day—so it could be rolled out quickly through GP surgeries and existing clinics. Success would mean more people staying smoke-free at six months and beyond, reducing lung cancer, heart disease, and the long-term burden on the health service. The trial also tracks carbon monoxide levels, cravings, and confidence, so researchers will understand *why* it works, not just whether it does. A health economic analysis will tell the NHS if the approach is worth the cost.
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Background: Standard smoking cessation support advises smokers not to use nicotine replacement therapy (NRT) whilst still smoking before their quit day. However this could be beneficial for a number of reasons. For example, it may decondition the link between smoking and associated environmental cues, it may familiarise smokers with NRT so they use it most effectively post-quit, and/or it may cause aversion, and therefore may make smoking less desirable. Evidence for the beneficial effect of nicotine preloading has proved inconclusive. Design/Methods: We will conduct a multi-centre, pragmatic, randomised controlled trial of four week nicotine patch treatment pre-quit day, alongside standard NHS stop smoking service (SSS), versus standard NHS SSS support without pre-quit patch. Participants will be recruited through GP practices and through an existing smoking cessation clinic. Support will be in the form of one-to-one clinic visits, and the standard support will be provided by the NHS. Outcomes/Follow-up: 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.
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