Title: Helping people cope with temptations to smoke to reduce relapse: A factorial randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Background Extended stop-smoking medicine use can help prevent relapse [2,3] but uptake and long-term use is low [4,5]. New vaporised nicotine products, e.g. e-cigarettes (EC), and other fast acting nicotine products may be more attractive for long-term use and hence useful as relapse prevention interventions (RPI). While several behavioural RPI have been found ineffective [2] recent data show that an online Structured Planning and Prompting Protocol (S3P), started at the beginning of the quit attempt, reduced relapse between 1-26 weeks from 71% to 61% [6]. Design Factorial design with 2 comparisons added to usual care (UC) 1) Pharmacological: Provision of fast-acting nicotine (NIC) product versus no NIC. Participants (Ps) offered a choice from a range of oral NRT/EC products. 2) Behavioural: Provision of S3P versus no S3P. UC is generally 8-12 weeks of medicine (e.g. varenicline or NRT) plus standard counselling provided from the start of the quit attempt. Population 1400 smokers: age 18+, who achieve 4 weeks abstinence while receiving UC. Recruitment 700 UK Ps from local SSS. 700 Australian Ps from Quitlines. Health technologies 1) NIC: Ps will choose a NIC (oral NRT/EC) to use if at risk of relapse, receiving 4-weeks supply initially, then offered another 4-week supply at 8-weeks post quit date (PQD). Ps will then buy/access any further supply themselves. 2) S3P: Ps will receive access to an online S3P that trains them to plan strategies to deal with temptations to smoke and reinforces and reminds on the need to have strategies ready using both the on-line resources and messages to mobile phones. The main strategy involves using self-statements such as ‘If in a situation where I want to smoke I will do X’. Procedure Ps will be referred by SSS and contacted by the study team who will check eligibility, obtain consent and collect baseline data. Ps will then be randomised to 1 of 4 arms (UC and 3 experimental) Smoking status will be measured at 3, 6 and 12 months PQD (biochemically validated at 12 months). There will also be a qualitative sub study and ecological momentary assessment monitoring period to understand how RPI work, by collecting data on use related to immediate needs. Outcomes PRIMARY-Differential relapse rates from 1-12 months PQD between intervention and control groups. SECONDARY-Sustained 12 month abstinence; non-daily smoking and reductions in cigarette consumption among treatment failures, NIC preferences, outcomes in relation to any continued NIC use; patterns of NIC use at 12 months, feasibility and acceptability of the two RPIs from participants’ perspectives, cost-effectiveness and cost utility. Sample size We expect 70% of participants to relapse between 1-12 months in UC [7], and that each RPI will reduce the rate to 58% and to 48% in those receiving both. Assuming no interaction and comparisons between those who receive (2 arms) and do not receive (2 arms) each intervention individually then 257 abstinent participants are needed per arm to detect a difference (90% power, alpha=0.025). We will recruit 300 people in each arm with an additional 50 people per arm for the EMA study. Timetable Months (M) 1-9: study set-up and S3P modification; M10-24: recruitment M25-37: follow-up; M38-42: analysis, write-up. Expertise The multidisciplinary team includes world-leading smoking cessation researchers and clinicians, behavioural scientists, trialists, and health economists.

Lay abstract: 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 [UC]), 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. Our 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, we now have evidence from an Australian trial to suggest that a Structured Planning and Prompting Protocol (S3P) can reduce relapse out to 6 months post-cessation. 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. We, and others, have tried to encourage continued use of oral 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. Thus, they might be effective in preventing relapse. Although EC have not been studied as closely as NRT products, they have a good safety profile. We will test two RPI in 1400 people who quit for 4-weeks using usual care interventions (e.g. 700 people who have quit using a UK SSS and 700 people who have quit using an Australian Quitline): the first, a web-based behavioural structured planning and prompting intervention provided at 4 weeks quit and reinforced up to 6 months quit, and the second, a pharmacological RPI, where we will offer people a choice of nicotine product, from a range (e.g. lozenge, mouthspray, EC products), to use if they feel at risk of relapse. Client preference for product will be an important outcome. We will provide up to 8 weeks supply free (in two batches) and then participants will need to buy their own if they want to continue use (to replicate likely real-world conditions). In short, we are testing whether providing an additional nicotine product and/or the S3P intervention to people who have quit for 4 weeks with UC reduces relapse at a year by comparing the rate of relapse between 1 and 12 months in those who received each RPI with those who did not. We will also establish whether the RPI provide acceptable returns for their costs, including cost per person quitting smoking and long-term cost savings to the NHS and health benefits to the population. We will also explore how people used the interventions and whether they have different effects on people from different socioeconomic backgrounds and those who stopped smoking using different methods. Given the close links between smoking and ill health and between smoking and health inequalities, reducing longer-term relapse in people will have substantial positive effects on public health.

Research activity codes: 6.1 PHARMACEUTICALS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH