Extrait

Background and study aims Smoking is the largest preventable cause of illness and premature death and costs the NHS around £5.2 billion per year. In Australia the investment in tobacco control is $71 million. Both the UK and Australia have strong tobacco control policies and continue to show a slow decrease in smoking rates. Most smokers are trying to quit and although many achieve short-term success, around 70% go on to relapse back to smoking. Typically stop smoking services (SSS) use a base medicine for 8-12 weeks complemented by counselling delivered face-to-face or via telephone (usual care), and are effective at helping people stop smoking in the short-term, but after one year 70% of persons quit at 1 month can be expected to have relapsed. Effective strategies to prevent smoking relapse are desperately needed. The study team have analysed the evidence for relapse prevention interventions (RPI). Traditional non-medicinal RPI for smokers (e.g. behavioural support such as teaching smokers to identify risky situations and to develop ways to cope with them) have not shown any benefit. However, there is now evidence from an Australian trial to suggest that a Structured Planning and Prompting Protocol can reduce relapse out to 6 months post-quit. This approach can be delivered online and may be enhanced by mobile phone text messages, which we have found to be acceptable in clients who have quit smoking using SSS. The extended use of stop smoking medicines can also help clients stop smoking while using them, but they need to be willing to continue use over longer periods. Many researchers have tried to encourage continued use of nicotine replacement therapy (NRT), but found uptake to be modest. New products that deliver nicotine in vapour, such as electronic cigarettes (EC), are becoming popular with smokers wanting to quit and may be more attractive for longer-term use, and so they might be effective in preventing relapse. Although EC have not been studied as closely as NRT products, they have a good safety profile. The aim of this study is to test two RPI, one using a web-based behavioural structured planning and prompting intervention and the other providing a choice of nicotine replacement product. Who can participate? Users of the Stop Smoking Service in the UK who haven’t smoked for the last two weeks. What does the study involve? Participants are randomly allocated to one of four groups. Those in the first group receive normal care. This involves being encouraged to continue use of base medication (e.g. Champix or NRT) until the end of the recommended period of use. They also receive text message support. Those in the second group are offered a smoking replacement product from a choice of up to three NRT and e-cigarette options to use as a coping strategy if at risk of relapse as well as text message support. Those in the third group receive a personalised plan, and access to the Structured Planning and Prompting Protocol (S3P) designed to focus planning on strategies to deal with temptations to smoke as well as text message support. Those in the fourth group receive the smoking replacement product plus online support. Participants in all groups complete online questionnaires at 3, 6 and 12 months post quit date (approximately 2, 5 and 11 months post-recruitment). In addition, those who report not having smoked for 12 months are given a saliva swab sample kit, along with instructions on how to provide the sample and a stamp addressed envelope to return it in to confirm their non-smoking status. What are the possible benefits and risks of participating? Participants may find the programmes helpful in preventing relapse back to smoking. There are no expected risks from using the online support tool or from receiving the text messages. There are also no risks expected from using a smoking replacement product (e.g. EC or NRT). These products do not contain tobacco, and therefore do not deliver the many harmful substances found in normal cigarettes. The most common side effects that people report when using these products are mild mouth/throat irritation, nausea and sleep disturbance. Where is the study run from? 1. Queen Mary University of London (UK) 2. Cancer Council Victoria (Australia) When is the study starting and how long is it expected to run for? April 2016 to September 2019 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Miss Anna Phillips [email protected]

Critère d'inclusion

• Smoking relapse prevention

Liens

• isrctn