Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

Trials, Jul 2014

Background 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. Methods/Design 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. Discussion 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. Trial registration Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

A PDF file should load here. If you do not see its contents the file may be temporarily unavailable at the journal website or you do not have a PDF plug-in installed and enabled in your browser.

Alternatively, you can download the file locally and open with any standalone PDF reader:

http://www.trialsjournal.com/content/pdf/1745-6215-15-296.pdf

Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

Trials Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial Nicola Lindson-Hawley 0 Tim Coleman 2 Graeme Docherty 1 Peter Hajek 6 Sarah Lewis 1 Deborah Lycett 5 Andy McEwen 4 Hayden McRobbie 6 Marcus R Munafò 3 8 Steve Parrott 7 Paul Aveyard 0 0 Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter , Woodstock Road, OX2 6GG Oxford , UK 1 Division of Epidemiology & Public Health, University of Nottingham, Clinical Sciences Building, Nottingham City Hospital , Hucknall Road, NG5 1PB Nottingham , UK 2 Division of Primary Care, University of Nottingham, Queen's Medical Centre , NG7 2UH Nottingham , UK 3 School of Experimental Psychology, University of Bristol , 12a Priory Road, BS8 1TU Bristol , UK 4 Health Behaviour Research Centre, Department of Epidemiology & Public Health, UCL , Gower Street, WC1E 6BT London , UK 5 Faculty of Health and Life Sciences, Richard Crossman Building, Coventry University , Priory Street, CV1 5FB Coventry , UK 6 Tobacco Dependence Research Unit, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry , 55 Philpot Street, Whitechapel, E1 2HJ London , UK 7 Department of Health Sciences, University of York , Seebohm Rowntree Building, Heslington, YO10 5DD York , UK 8 MRC Integrative Epidemiology Unit (IEU), University of Bristol , 12a Priory Road, BS8 1TU Bristol , UK Background: 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. Methods/Design: 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. Discussion: 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. Trial registration: Current Controlled Trials ISRCTN33031001. Registered 27 April 2012. Smoking; Nicotine; Preloading; Tobacco; Cessation; Quitting; Addiction; Treatment Background People who try to stop smoking typically experience urges to smoke, often described as cravings, frequently in response to environmental cues associated with smoking (such as drinking alcohol). These urges decrease in intensity and frequency with time. The key to stopping smoking is to resist these urges. Effective medication for smoking cessation reduces the intensity of the urges [ 1,2 ], and this is the likely mechanism of action. There are three licensed medications for smoking cessation: bupropion, varenicline, and nicotine replacement therapy (NRT). Varenicline is a nicotinic partial agonist and it is therefore surprising to find that it is more effective than a full agonist, nicotine [ 3 ]. An investigation considered the possible mechanisms of action and compared varenicline, bupropion, and a placebo [ 4 ]. It found that varenicline reduced urges to smoke to a lower level than did bupropion. Furthermore, varenicline led to lower satisfactio (...truncated)


This is a preview of a remote PDF: http://www.trialsjournal.com/content/pdf/1745-6215-15-296.pdf

Nicola Lindson-Hawley, Tim Coleman, Graeme Docherty, Peter Hajek, Sarah Lewis, Deborah Lycett, Andy McEwen, Hayden McRobbie, Marcus R Munafò, Steve Parrott, Paul Aveyard. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial, Trials, 2014, pp. 296, 15, DOI: 10.1186/1745-6215-15-296