Research Information for Practices
If you have any queries please contact your local PCRN first:
Local PCRN Contact:
Research Team
Contact:
Elaine Butcher
Tel. 07867 468556
Research Nurse
Email: E.Butcher@warwick.ac.uk
Miss Nicola Lindson
Primary Care Clinical Sciences, University of Birmingham, Edgbaston,
Birmingham B15 2TT
n.l.lindson@bham.ac.uk
Study Title: The Preloading Trial: An Open Label Pragmatic Randomised Controlled Trial of
Nicotine Preloading for Smoking Cessation
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, 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. An investigation considered the possible mechanisms
of action and compared varenicline, bupropion, and placebo. It found that varenicline reduced urges to
smoke to a lower level than did bupropion. Furthermore, varenicline led to lower satisfaction from a lapse
(smoking episode) after quit day than did bupropion. However, many other mood related symptoms of
withdrawal were of similar intensity. This suggests that a key mechanism of action of the smoking
cessation pharmacotherapies, that relates directly to efficacy in promoting cessation, is controlling urges
and reducing satisfaction from smoking. Unlike NRT, varenicline is used for at least a week and up to two
weeks prior to quit day, which might explain superior efficacy. Using NRT while smoking reduces
satisfaction from smoking so it seems logical to examine whether NRT used prior to quitting could make
smoking cessation more successful. This is nicotine preloading.
Aims: To examine the relative efficacy, safety and cost effectiveness of standard NHS stop-smoking
treatment versus standard treatment plus nicotine patch worn for 4 weeks prior to quitting. Those who
consent will be randomised into one of two treatment groups:
1) Intervention arm – participants are given and asked to use 4 weeks worth of 21mg nicotine
patches (provided by GSK free of charge) for 24 hours per day, whilst smoking as normal prior to
quitting, alongside standard NHS stop smoking service support.
2) Control arm - no Nicotine Replacement Therapy (NRT) administered prior to quit day and usual
NHS treatment/advice thereafter.
The research will be carried out by the PCRN research team or research nurse from each practice. The
research nurse will see patients at the time of enrolment (baseline clinic visit), 1 week later (clinic visit) 1
week following their quit day (telephone consultation) 6 and 12 months following their quit day
(consultations in the first instance will be over the phone, where all participants claiming to be abstinent
will be invited to a clinic visit to validate this using carbon monoxide monitoring). Please note that after
the initial 2 visits patients will be referred to the standard NHS Stop Smoking Advisor based at the practice.
Version 1 –The Preloading Trial RISP 03/04/2012
Recruitment Target: Patients from Worcestershire and Warwickshire PCT’s
Sponsor: University of Birmingham
Funders: National Institute for Health Research Health Technology Assessment Programme
Study Start: 02.02.2012
Study Finish: 01.07.2014
GP Involvement in the study:
 Review the patient search to further check eligibility
Practice Involvement in the Study:
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Search their database to identify eligible patients
A GP would review the patient list to further check eligibility
Organise a mail merge and post invite letters
Have an established NHS Stop Smoking Service based at the practice
Patient Involvement in the Study:
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Patients will have to be willing to set a quit date in 4 weeks time and agree to either wear a
nicotine patch for 4 weeks prior to quitting or smoke as normal for 4 weeks and receive the
standard NHS Stop Smoking Service. Patients will receive payments for travel and
inconvenience.
Inclusion Criteria:
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Smokers (defined as regular smokers of cigarettes, cigars, and tobacco cigarettes combined with
marijuana) aged ≥18 years of age (assessed on telephone screening)
Smokers who, in the judgement (see below for how judgement shall be made) of the trial researcher,
would be suitable for preloading (assessed on telephone screening and in clinic).
Seeking NHS support to stop smoking (assessed on telephone screening) and willing to quit in 4
weeks
Able to understand and consent to, and willing to comply with, study procedures (assessed on
telephone screening and in clinic).
Exclusion Criteria:
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Pregnant or breastfeeding (assessed on telephone screening)
Extensive dermatitis/other skin disorder that precludes patch use (assessed on telephone and clinic
screening)
Acute coronary syndrome or stroke within the past three weeks (assessed on telephone screening)
Active phaeocromocytoma and uncontrolled hyperthyroidism (assessed on telephone screening)
Please note that telephone screening and the booking of patients will be carried out by the study team at
the University of Birmingham
Study Reimbursement:
Study support costs (for time/resource expenses) are available for this study and will be paid to all practices
participating in the study. For an average practice recruiting 30 people this amounts to £1,680 or £56 per
patient.
If you wish to take part in the study, what happens next?
Please email – E.Butcher@warwick.ac.uk
Thank you for your interest.
Version 1 –The Preloading Trial RISP 03/04/2012