Relapse Prevention (RP) Trial

• Research type

  Research Study

• Full title

  Helping people cope with temptations to smoke to reduce relapse: A factorial randomised controlled trial

• IRAS ID

  200540

• Contact name

  Sally Burtles

• Sponsor organisation

  Queen Mary University of London, Joint Research Management Office

• Duration of Study in the UK

  3 years, 6 months, 1 days

• Research summary

  Traditional behavioural relapse prevention interventions, RPI have not shown any benefit. However, evidence from an Australian trial suggests that a Structured Planning and Prompting Protocol (S3P) can reduce relapse. This can be delivered online and may be enhanced by text messages, which we found acceptable in clients who quit smoking using Stop Smoking Services (SSS). Extended smoking replacement (SR) product use can also help clients stop smoking while using them, but they need to be willing to continue use over longer periods. Continued use of oral nicotine replacement therapy (NRT), however, is modest. New products delivering nicotine in vapour, e.g. electronic cigarettes (EC), are becoming popular with smokers wanting to quit and may be more attractive for longer-term use. Thus, they might be effective in preventing relapse. Although EC have not been studied as closely as NRT, they have a good safety profile. We will test two RPI in 1400 people who quit for 4-weeks using the SSS: 1. the online behavioural S3P RPI provided from 4-weeks quit, and 2. a SR intervention, offering a choice of SR product (e.g. oral NRT/EC) to use if at risk of relapse. In short, we are testing whether providing a SR product and/or the S3P intervention to people who have quit for 4 weeks with usual care reduces relapse at a year by comparing relapse rates between 1 and 12 months in those who received each RPI with those who did not. We will also establish whether RPI provide acceptable returns for their costs, and explore how people used them and whether they have different effects on people from different socioeconomic backgrounds/those who stopped smoking using different methods. Given the close links between smoking and ill health and smoking and health inequalities, reducing longer-term relapse will have substantial positive effects on public health.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  16/LO/1771

• Date of REC Opinion

  24 Oct 2016

• REC opinion

  Further Information Favourable Opinion