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Effect of e-Cigarettes Plus Counseling on Smoking Cessation
Quick Takes
- Nicotine e-cigarettes plus counseling may increase absence compared to counseling alone in the short-term.
- Use of nonstudy e-cigarettes suggest nicotine addiction remains a significant factor among adults using e-cigarettes to assist in quitting smoking.
Study Questions:
When used for smoking cessation, are e-cigarettes associated with greater smoking quit rates?
Methods:
The E3 (Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation) trial was a randomized clinical trial, which enrolled adults motivated to quit smoking at 17 Canadian sites. A total of 801 adults were screened and 274 met eligibility for enrollment between November 2016 and September 2019. Participants were randomized to nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes for 12 weeks. All participants received individual counseling. The primary endpoint was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks. The original primary outcome was to be measured at 52 weeks; however, manufacturing delays (of the e-cigarettes) resulted in early termination of enrollment and the modification of the outcome measurement. Participants missing data were assumed to be smoking. Secondary endpoints included were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.
Results:
A total of 376 participants (77% of 486 target sample size) were included. Mean age was 52 years and 47% were women. Average smoking duration was 35 years, with most participants reporting prior quit attempts (91%). Participants were randomized to nicotine e-cigarettes (n = 128), non-nicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling versus counseling alone at 12 weeks (21.9% vs. 9.1%; risk difference [RD], 12.8 [95% confidence interval (CI), 4.0-21.6]), but not 24 weeks (17.2% vs. 9.9%; RD, 7.3 [95% CI, –1.2 to 15.7]). Point prevalence abstinence for non-nicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs. 9.1%; RD, 8.2 [95% CI, –0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs. 9.9%; RD, 10.6 [95% CI, 1.8-19.4]). Participants (37%) randomized to nicotine e-cigarettes also reported using nonstudy e-cigarettes. Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; non-nicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).
Conclusions:
The investigators concluded that among adults motivated to quit smoking, nicotine e-cigarettes plus counseling versus counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and non-nicotine e-cigarettes, suggesting that further research is needed.
Perspective:
These data highlight the difficulty of sustained effective smoking interventions. Unfortunately, early termination of this current study limited the power to detect long-term changes in smoking.
Clinical Topics: Cardiovascular Care Team, Prevention, Smoking
Keywords: Carbon Monoxide, Cough, Counseling, Electronic Nicotine Delivery Systems, Electronic Nicotine Delivery Systems, Nicotine, Primary Prevention, Smoking, Smoking Cessation, Tobacco Use Cessation Devices, Tobacco Products
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