A three-arm randomized trial led by Katie Myers Smith, Peter Hajek, and colleagues at Queen Mary University of London—registered as ISRCTN 61193406 and funded by the NIHR Health Technology Assessment programme—delivered a direct answer to a practical clinical question. If you hand a daily smoker an e-cigarette starter kit without any of the intensive behavioral counseling that earlier trials bundled with the device, does it still work? And if you add back brief telephone support, how much does it improve? The study, published in NEJM Evidence in October 2026 (DOI 10.1056/EVIDoa2600065), randomized 1,170 UK adults and followed them with biochemically validated carbon-monoxide readings at 6 and 12 months. The results change how we should think about real-world cessation services, especially where counseling capacity is limited.
Bottom Line Up Front#
Without any multisession counseling, an e-cigarette starter pack produced validated sustained abstinence at 6 months in 11.3% of participants—nearly double the 6.4% achieved by the NHS SmokeFree automated email program. Adding weekly telephone calls for four weeks pushed the quit rate to 21.1%, again roughly doubling. The effect sizes—relative risk 1.76 for e-cigarettes versus messages, and 1.87 for e-cigarettes plus support versus e-cigarettes alone—were statistically significant with 97.5% confidence intervals that excluded no effect. At 12 months the pattern held: 9.0% for e-cigarettes alone, 5.4% for messages, 16.8% for the combined arm. These are not marginal differences; they represent a real shift in what patients can expect when support is unavailable versus when it is present.
What the Trial Actually Tested#
Most earlier trials that showed e-cigarettes help smokers quit provided them together with multiple face-to-face or telephone counseling sessions. That creates a practical problem: counseling is not always available, it is not always wanted by the smoker, and it adds real cost to treatment programs. The researchers set out to separate the contribution of the device from the contribution of the support.
Participants were adults aged 18 or older who smoked daily, wanted help stopping, and had no strong preference either for or against using e-cigarettes. The team excluded pregnant people and anyone already using e-cigarettes at least weekly. Recruitment ran from September 2021 through November 2023 across 14 general practices, six hospitals, Meta advertising, and a local stop-smoking service. Ethics approval came from the National Research Ethics Service (20/SW/0179).
Randomization was 1:1:1 using permuted blocks of 9 to 18, with no stratification. The statistician was blinded during analysis. Staff collecting follow-up data—including the carbon-monoxide readings—were not blinded, which is a limitation worth noting.
The three arms were cleanly distinct. The supportive-messages group received the standard NHS SmokeFree automated email sequence: advice, tips, and daily motivational messages over 28 days, starting on the target quit date. They were asked not to use e-cigarettes. The EC-only group received a refillable device, two 10-ml bottles of 18 mg/ml nicotine e-liquid in tobacco and strawberry flavors from Lumo Liquids, five spare coils, and a brief instruction leaflet, plus a leaflet on buying further supplies. Supplies lasted about two weeks; participants then purchased their own. They were asked not to register with SmokeFree for the first four weeks. The EC+ group received everything in EC-only plus a call on the target quit date and weekly calls for the following four weeks, following standard UK stop-smoking service practice.
The primary outcome was validated sustained abstinence at 6 months, defined by the Russell Standard: no more than five cigarettes between two weeks after the quit date (quit date was usually set to 1 week post-randomization) and the 6-month assessment, no smoking at all in the past week, an expired carbon-monoxide reading below 8 parts per million, and no contradiction from any earlier self-report. Missing data were treated as smoking in the primary analysis—a conservative assumption—though sensitivity analyses using complete cases, missing-not-at-random imputation, and per-protocol exclusions all pointed in the same direction.
Results#
At 6 months the validated abstinence rates were 6.4% in the supportive-messages arm, 11.3% in EC-only, and 21.1% in EC+. The relative risk for EC-only versus messages was 1.76 with a 97.5% confidence interval of 1.03 to 3.01 and a P value of 0.018. For EC+ versus EC-only, the relative risk was 1.87 with a 97.5% CI of 1.27 to 2.75 and P below 0.001. Both comparisons were prespecified with a Bonferroni-adjusted alpha of 0.025, so the thresholds were stricter than the conventional 0.05.
Smoking reduction showed similar trends. Among people who were still smoking in the previous seven days, the mean reduction in cigarettes per day at 6 months was 6.4 in the messages group, 8.2 in EC-only, and 9.6 in EC+. The adjusted difference between EC-only and messages was 2.05 fewer cigarettes per day (95% CI 0.78 to 3.32), while the additional reduction from adding support to EC-only was small and not statistically significant (0.27; 95% CI −1.23 to 1.77).
In other words, the device drives most of the reduction; the counseling mainly pushes people over the abstinence threshold.
Treatment ratings reflected these differences. On a 1-to-5 helpfulness scale, the median rating was 2 (interquartile range 1–3) for messages, 4 (3–5) for EC-only, and 4 (4–5) for EC+. The likelihood of recommending the intervention to friends or family was 17.5% for messages, 64.3% for EC-only, and 76.3% for EC+. Those satisfaction differences matter for adherence and real-world uptake.
What Happened Over the Longer Term#
At 12 months, validated sustained abstinence was 5.4% for messages, 9.0% for EC-only, and 16.8% for EC+. The relative risks were consistent: 1.67 for EC-only versus messages (95% CI 0.99 to 2.81) and 1.86 for EC+ versus EC-only (1.27 to 2.74). Among participants who had not achieved abstinence at 4 weeks, sustained abstinence measured between 6 and 12 months was low across all groups—3.6% for EC-only, 2.8% for messages, and 1.8% for EC+—which suggests that early success predicts long-term success more than late breakthrough does.
Self-reported 7-day abstinence at 12 months was 27.5% for EC-only and 32.5% for EC+, without being statistically different.
Long-term e-cigarette use among abstainers was common: about 80 to 90% at both 6 and 12 months, usually with falling nicotine strength. That pattern aligns with harm-reduction expectations rather than a simple switch-and-stop model. Serious adverse events were reported in 8.1% of the messages group, 10.8% in EC-only, and 10.7% in EC+. There were four deaths—two in EC-only and two in EC+—with pneumonia identified in one case and the others of unknown cause. Forty-two participants reported adverse reactions to the e-cigarette device, most commonly mouth, throat, or airway irritation (commonly reported symptoms, particularly during e-cigarette use initiation); 15 of those discontinued use (8 in EC-only, 7 in EC+).
The trial was not powered for safety outcomes, so these figures should be interpreted with appropriate caution, especially given a baseline imbalance: 27.0% of the EC-only group reported a history of respiratory problems versus 20.3% in the messages group.
Why the Per-Protocol Analysis Strengthens the Case#
In the supportive-messages arm, 10.3% were using e-cigarettes at 4 weeks, 24.4% at 6 months, and 24.7% at 12 months. Among validated abstainers in that arm, 68.0% at 6 months and 76.2% at 12 months were using e-cigarettes—meaning the primary analysis, which treats these participants as message-group successes, likely underestimates the true e-cigarette effect.
The prespecified per-protocol sensitivity analysis excluded anyone who crossed over. After that exclusion, validated sustained abstinence at 6 months was 2.7% in messages, 11.3% in EC-only, and 21.1% in EC+. The gap widened dramatically for the control arm, confirming that when people actually adhered to the assigned treatment, e-cigarettes performed substantially better than automated messaging.
Practical Takeaway for Clinicians and Services#
The trial supports a tiered approach. Where multisession telephone counseling is available, combining it with an e-cigarette starter pack roughly doubles sustained abstinence compared with the device alone. Where it is not available (whether because of cost, workforce shortages, or patient preference), providing the device alone still produces nearly twice the quit rate of automated messaging, at a satisfaction level that most participants rated as helpful. That is not a second-best fallback; it is an effective standalone intervention with real clinical value.
The starter pack itself was minimal: a refillable device, two bottles of 18 mg/ml liquid, spare coils, a leaflet, and brief instruction. No specialized pharmacy, no complex regimen. The counseling was brief: one call on quit day, then weekly calls for four weeks. That is a low-intensity, replicable model that could be scaled through existing stop-smoking services without requiring new infrastructure or high costs.
Conclusion#
This trial confirms that behavioral support improves smoking-cessation outcomes when paired with e-cigarettes, but it also demonstrates that e-cigarettes alone are an effective, high-satisfaction intervention that outperforms automated messaging. For clinicians, policymakers, and service planners, the message is practical: offer counseling when you can, because it roughly doubles the quit rate; but when capacity is limited, the device by itself remains a clinically valuable option backed by validated, long-term data.
Q&A#
How does this compare with the 2019 NEJM trial by Hajek and colleagues? The 2019 study reported 6-month abstinence of about 18% with e-cigarettes plus face-to-face support, versus 9.9% with nicotine-replacement therapy. The current trial’s EC+ arm reached 21.1% with telephone rather than in-person support—suggesting telephone counseling, while less intensive, may be nearly as effective when paired with an attractive device.
Is 21% a strong quit rate? In the context of smoking cessation trials, yes. Most behavioral-only or messaging-only interventions produce rates in the single digits. Reaching over one in five with a brief telephone-plus-device protocol places this among the more effective cessation strategies available in routine care.
Can these results apply outside the UK? The study population was broadly representative of people accessing UK stop-smoking services—about half female, mean age 48, average 19 cigarettes per day, just under 60% with high nicotine dependence (Fagerström score above 5). Generalizing to countries with different tobacco policies requires caution, but the mechanism—device satisfaction plus brief support—is not uniquely British.
Sources#
Myers Smith K, Przulj D, Pesola F, Ladmore D, McRobbie HJ, Phillips-Waller A, McAlpine K, Ricketts W, Sasieni P, Parrott S, Li J, Bauld L, Dobbie F, Miller M, Hajek P. E-Cigarettes with and without Behavioral Support for Smoking Cessation. NEJM Evidence. 2026;5(11). doi:10.1056/EVIDoa2600065
