Title: Do e-cigarettes help smokers quit when not accompanied by intensive behavioural support?
Funder: Department of Health and Social Care

Abstract: Background to the research_x000D_ We recently completed a large trial which showed that e-cigarettes are more effective in helping smokers quit than nicotine replacement treatments, such as patches or chewing gum. E-cigarettes and NRT were used within the specialist stop-smoking services and accompanied by weekly support sessions with smoking cessation advisors. _x000D_ _x000D_ Stop-smoking services are very important, especially for highly dependent smokers. However, attendance requires time and effort and under 5% of smokers attend such treatment. Less intensive treatments are likely to be less effective, but they can be expected to reach more smokers and thus help more people. _x000D_ _x000D_ We propose to conduct the next trial that will show whether, and to what extent, e-cigarettes can help smokers quit with less intensive support (either with telephone support or no support). The trial results will determine whether public health messages need to encourage all smokers interested in switching to e-cigarettes to attend stop-smoking services, or whether those that cannot or do not wish to attend intensive programs can benefit from simpler options. _x000D_ _x000D_ Provided the interventions works, we also want to see what would help NHS staff to refer smokers to this new way of helping smokers, and smokers to use it. _x000D_ _x000D_ Research methods used_x000D_ We propose to test two approaches that provide e-cigarette starter packs: Either with five weekly support telephone calls from an e-cigarette helpline; or just with initial one-off telephone advice. _x000D_ _x000D_ This will be compared with the NHS Smokefree Quit Now online programme that provides e-mails and/or texts daily for 28 days with advice on coping with cravings, using medications and other aids, encouragement to attend local stop-smoking services, and motivational messages. This is currently the most economical approach in use. _x000D_ _x000D_ A total of 1,170 smokers will be allocated, by chance, to one of these three study treatments and we will record how many have stopped smoking 6 and 12 months later. Those who have quit smoking will attend for a breath test to confirm this. Participants who do not provide this information or do not pass the breath test will be counted as non-quitters. _x000D_ _x000D_ The project will also include a qualitative sub-study. Doctors and nurses often do not know much about e-cigarettes, and like everyone else, they see contradictory media stories. Many do not feel comfortable discussing e-cigarettes but may welcome an option to refer smokers interested in e-cigarettes to an approved e-cigarette helpline that can provide information, assess smokers, and hand out e-cigarette starter packs as appropriate, whether with or without further telephone support. The trial above will show whether the helpline would help smokers quit; the sub study will identify barriers and facilitators to health professionals referring smokers to it and smokers using it. Doctors and nurses (as well as smokers who did and did not take part in the main study) will be interviewed, so that if the intervention is found effective, we identify the best ways of putting it into practice. _x000D_ _x000D_ Smokers and stop-smoking advisors helped with the project development and will remain involved throughout the study. This would be the first research of its kind and we believe that it will generate new information that will be useful for smokers in the UK and worldwide.

Lay abstract: Background _x000D_ _x000D_ Our recent NIHR trial has shown that e-cigarettes (EC) are more effective than NRT when both interventions are accompanied by intensive behavioural support. The key priority now is to establish whether, and to what extent, EC can help smokers quit when accompanied by less intensive support; or with no support apart from provision of an EC starter kit. If EC are effective when provided with just helpline support, or even with no support, this would have an important impact on public health messages and on the practice of front-line clinicians. _x000D_ _x000D_ Methods_x000D_ _x000D_ Design: Randomised controlled trial (RCT)_x000D_ _x000D_ Participants: Smokers who are currently not using an EC will be recruited via Local Clinical Research Network (LCRN) research nurses and health care professionals (HCPs) in both secondary and primary care. _x000D_ _x000D_ Study arms_x000D_ _x000D_ NHS Quit Now programme (QN) – control arm: Participants will be enrolled in QN, a comprehensive automated interactive stop-smoking treatment package that involves daily texting or emails for 28 days, referral options and online support. _x000D_ _x000D_ EC starter pack with no ongoing support (EC): Participants will receive instructions on EC use from a helpline and a starter pack with a refillable EC will be sent to them by post. They will be asked to purchase further EC supplies of their choice themselves. _x000D_ _x000D_ EC starter pack with helpline support (EC+): Participants will receive the same intervention as the EC arm, but will also receive 5 supportive phone calls; one on the Target Quit Date and then weekly for four weeks. _x000D_ _x000D_ Primary outcome: Biochemically validated sustained abstinence from smoking at six months, with participants lost to follow-up included as non-abstainers. _x000D_ _x000D_ Secondary outcomes: Biochemically validated smoking cessation at 12 months and between 6 and 12 months. Self-reported 7-day point prevalence abstinence at 4 weeks, 6 and 12 months, cigarette consumption in non-abstainers at all time points, frequency and severity of urges to smoke and intensity of two cigarette withdrawal symptoms (mouth ulcers and constipation) at 4 weeks, self-reported weight at each time point, respiratory symptoms at each time point, treatment ratings and adherence, adverse reactions, cost effectiveness of interventions, primary and secondary care HCPs’ and smokers’ views of an EC helpline._x000D_ _x000D_ Sample size: In our TEC trial, the 6-month quit rate in the EC arm was 35%. We estimate this will be reduced to 25% with phone calls replacing face-to-face sessions and to 15% with removing contacts altogether. The only trial of a social media intervention that included biochemical validation reported 6% 7-day abstinence at six months, so we estimate a quit rate of 6% in the QN arm. N=390 in each arm (N=1,170 in total) will provide 90% power to detect these differences (p<0.05, double sided, adjusted for multiple comparisons). _x000D_ _x000D_ Timeline: The total project duration is 45 months._x000D_ _x000D_ Impact: The trial will help to determine whether public health messages and HCPs’ advice needs to focus on encouraging all smokers interested in switching to EC to attend stop-smoking services, or whether those that cannot or do not wish to join intensive programs can benefit from simpler options.

Research activity codes: 6.1 PHARMACEUTICALS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE