E-Cigarettes with and without Behavioral Support for Smoking Cessation

BACKGROUND: Trials that have shown that e-cigarettes are effective in helping people quit smoking typically provided behavioral support in addition to e-cigarettes. Behavioral support is not always available or wanted, but it is not known whether e-cigarettes are effective without it. METHODS: Participants who smoked and were motivated to quit were randomly assigned to National Health Service SmokeFree automated email messages (supportive messages), an e-cigarette starter pack alone (EC-only), or an e-cigarette starter pack plus multisession telephone-based behavioral support (EC+). The primary outcome was biochemically validated sustained abstinence from smoking at 6 months. Participants who were lost to follow-up or did not provide biochemical validation were assumed to continue to smoke. A significance level of 0.025 was prespecified for each of the two primary comparisons (EC-only vs. supportive messages and EC+ vs. EC-only). RESULTS: The 6-month abstinence rates were 6.4% in the supportive messages group, 11.3% in the EC-only group (EC-only vs. supportive messages relative risk 1.76; 97.5% confidence interval [CI], 1.03 to 3.01; P=0.018), and 21.1% in the EC+ group, (EC+ vs. EC-only relative risk 1.87; 97.5% CI, 1.27 to 2.75; P<0.001). Serious adverse events were reported by 8.1%, 10.8%, and 10.7% of participants in the supportive messages, EC-only, and EC+ groups, respectively. There were four deaths, two in the EC-only group and two in the EC+ group. CONCLUSIONS: E-cigarettes without further support were more effective than supportive messaging in helping people achieve sustained validated abstinence from smoking at 6 months. E-cigarettes with multisession telephone-based support were more effective than e-cigarettes alone. (Funded by The National Institute for Health and Care Research Health Technology Assessment programme (NIHR129627); ISRCTN number, 61193406.).