Title: Optimising pharmacist-based treatment for smoking cessation
Funder: Department of Health and Social Care

Abstract: BACKGROUND Smoking causes more than 100,000 deaths annually in the UK and is a major preventable cause of cardiovascular disease, chronic respiratory disease and cancer. [1] Thus smoking cessation is a major public health priority.[2] Nicotine replacement is an effective, well established treatment for tobacco dependence. Nicotine in the form of adhesive skin patches or lozenges reduces craving for tobacco and the urge to smoke. However, about half of smokers on standard replacement doses take in less nicotine than when smoking and are thus ‘underreplaced’. Systematic reviews suggest that increasing total nicotine dose in the form of co-therapy improves quit rates.[3] However there is considerable individual variation in nicotine metabolism so whilst many are under dosed, a significant proportion (about 10%) are overdosed. More appropriate dosing could lead to more effective treatment, fewer side effects and reduced drug costs, however this therapeutic approach has not yet been formally evaluated. Technology is available to determine individual nicotine metabolic rate easily. Pilot data shows personalised dose adjustment using a diagnostic test and an interpretive computer algorithm is feasible in pharmacies and suggests improved quit rates. We will develop a personalised smoking cessation intervention and an educational package to build pharmacists’ consultation skills and knowledge about nicotine replacement therapy, aiming to increase the numbers of smokers entering cessation programmes. 35,000 quit attempts take place in pharmacies in London each year [4] – increasing uptake and success rates could have a major impact on tobacco use. RESEARCH PLANS PHASE 1: Systematic review of studies on changing health behaviours in pharmacies to identify aspects of successful interventions that could be applied to smoking cessation, particularly underlying theories. We will update our review of computer advice on drug dosing to identify features of successful systems to incorporate into the intervention and perform a new review of decision support in pharmacies. PHASE 2: Observational studies on patients and pharmacists in successful and unsuccessful smoking cessation consultations. Detailed analysis of transcripts of informative consultations. Identification of strategies to promote recruitment to smoking cessation services and provide effective support during the quit attempt. PHASE 3: Systematic reviews and qualitative work will feed directly into development of educational intervention. Framework for the intervention is likely to be PACE methodology which we used successfully previously to promote effective use of medication for treatment of asthma. Elements of effective interventions identified in the reviews will be added eg (MI). PHASE 4: Two by two factorial RCT (1200 participants, 60 pharmacies) to evaluate effectiveness of (i) educational intervention (ii) personalised dosing v standard therapy v high dose nicotine replacement. Compare costs and side effects. RESEARCH TEAM Experts in health service research, clinical trials, genetics, behavioural psychology, sociology, pharmacology, community pharmacy, health economics, statistics and lay advisors. Links well-established in UK, France and USA and UK PCTs and Department of Health. Work builds on previous research in smoking cessation, developing pharmacist interventions and clinical trials. RESEARCH ENVIRONMENT Policy makers at National and PCT level, trialists highly experienced in community based RCTs. Full support of Barts and The London, PCTU. State of the art Genome Centre. OUTPUTS OUTCOMES AND IMPACTS Outputs: effective methods of facilitating health behaviour change in pharmacies; computerised dose adjustment; effective pharmacist consultation techniques; effectiveness and cost analysis of personalised dose adjustment for nicotine replacement. Effectiveness of high dose nicotine replacement therapy. Outcomes: increased recruitment into smoking cessation services, improved quit rates, reduced tobacco related mortality. Intervention could be implemented quickly within the NHS. The Chief Pharmacist at NHS Glasgow and Clyde has offered to host implementation studies. Knowledge gained could be used to support general diversification of pharmacists’ role - essential part of new primary health care environment.[5] PUBLIC INVOLVEMENT A lay advisor with whom we have worked effectively before is a coapplicant, contributed to the design and will sit on the steering group to ensure that research remains focussed on needs of service users. ETHICAL IMPLICATIONS Nicotine replacement therapy is available over the counter – this programme seeks to optimise uptake and dosage. Not a trial of an investigational medicinal product (CTIMP). DNA analysis used to assess metabolic profile and give dosage recommendations. Results of analysis will not be disclosed to pharmacist or participant.

Lay abstract: Smoking is the major cause of preventable illness and death in the UK. However people who stop smoking very quickly lose their increased risk of disease, so about ten years after stopping smoking the risk has fallen to the same level as someone who has never smoked. Thus stopping smoking is one of the most important moves towards a healthier lifestyle. Nicotine replacement therapy is a tried and tested treatment for tobacco dependence. This treatment aims to replace the addictive substance in cigarettes (nicotine) with a pure form of that drug which is not harmful and which helps to reduce the urge to smoke, making quitting easier. However, we have shown that each individual smoker has a very different individual requirement for nicotine and this is due to genetic variations in the nicotine metabolic profile (the way in which a person's body is programmed to respond to nicotine). We have conducted a small study in pharmacies to identify the metabolic profile and give each smoker a more accurate nicotine replacement therapy dose. We hope that by doing this we can make treatment more effective and cause fewer side effects. The study showed that this approach is possible in a community setting and suggested good quit rates. We now need to develop the programme and test it on a larger scale to see whether it is worthwhile offering routinely. We will compare personalised dosing to standard dosed nicotine replacement therapy in a randomised trial. We will also compare personalised to high dose nicotine replacement therapy which is simpler and likely to be effective but is a little more expensive and may cause more side effects. We will also devise a brief education programme for pharmacists to help them to talk more effectively with patients about nicotine replacement. There is relatively little existing research on effective smoking cessation consultation techniques for pharmacists so we plan to conduct studies interviewing pharmacists and their patients after successful and unsuccessful smoking cessation consultations to identify key elements of the interaction that lead to success. Compared with other treatments, nicotine replacement is cheap and effective - it is also easily available without prescription. We plan to optimise its use helping more people to stop smoking and lead longer, healthier lives.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;STROKE;CARDIOVASCULAR;RESPIRATORY