A new trial will test whether giving smokers an e-cigarette starter kit—with or without a few helpline calls—can help them quit, without requiring them to attend stop-smoking services. The question matters because most smokers do not join intensive behavioural programmes. The researchers’ own previous trial showed e-cigarettes work better than nicotine patches when both come with face-to-face support. But that leaves a gap: what about the smoker who just wants a kit in the post? If e-cigarettes help even with minimal or no ongoing support, that changes what doctors and public health campaigns recommend. If the trial succeeds, the impact could be felt in everyday GP surgeries and pharmacy counters. Clinicians might routinely offer an e-cigarette starter pack as a first-line option, rather than only referring smokers to time-intensive services. For the health system, that could mean a cheaper, simpler route to cutting smoking rates—one that reaches people who would otherwise try to quit alone and fail. The trial also tracks cost-effectiveness, so funders will know whether the simpler options deliver value for money.
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Background 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. Methods Design: Randomised controlled trial (RCT) 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. Study arms 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. 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. 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. Primary outcome: Biochemically validated sustained abstinence from smoking at six months, with participants lost to follow-up included as non-abstainers. 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. 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). Timeline: The total project duration is 45 months. 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.
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