Summary
Introduction:
This text provides a summary of a randomized clinical trial examining the efficacy of e-cigarettes for smoking cessation in a general population. The study was conducted at 17 centers in Canada and enrolled individuals who smoked a mean of 10 cigarettes or more per day and had a moderate or strong desire and intention to quit. Participants were randomized to receive nicotine e-cigarettes plus counseling, nonnicotine e-cigarettes plus counseling, or counseling alone.
Key Points:
* The primary end point was point prevalence smoking abstinence at 12 weeks following randomization, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide level of 10 ppm or less.
* The 7 secondary end points examined at multiple follow-ups included 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.
* The trial was terminated early due to a prolonged and unforeseen delay in e-cigarette manufacturing.
* Participants received individual smoking cessation and relapse prevention counseling (minimum 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15-20 minutes at clinic visits).
* The nonnicotine e-cigarettes plus counseling group was included to examine the behavioral aspect of e-cigarettes.
* Participants were instructed to use the e-cigarettes as desired and were not required to quit immediately at the baseline visit.
* Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%), but not at 24 weeks (17.2% vs 9.9%).
* Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%), but was significantly greater at 24 weeks (20.5% vs 9.9%).
* Adverse events were common, with the most common being cough (64%) and dry mouth (53%).
Main Message:
The study found that among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks, but the difference was no longer significant at 24 weeks. The trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. It is important to note that adverse events were common, and the long-term health effects of e-cigarette use are still unknown.
Citation
Eisenberg MJ, Hébert-Losier A, Windle SB, et al. Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2020;324(18):1844-1854. doi:10.1001/jama.2020.18889
