E3 Trial: Nicotine E-Cigarettes With Individual Counseling Is More Effective Than Individual Counseling in Smoking Cessation

Dr. Mark J. Eisenberg and his colleagues presented the interim results of the E3 trial to the American College of Cardiology 2020 Meeting. The study was also published in the CJC open journal. According to the E3 trial, the most efficacious way for smoking cessation is nicotine e-cigarettes (ECs) with counseling followed by non-nicotine ECs with individual counseling and individual counseling alone.

Given the clear health benefits of smoking cessation and the increasing desire of smokers for adopting e-cigarettes as a way of quitting smoking, it sounds reasonable to evaluate the efficacy of these agents in smoking abstinence. However, the increasing number of e-cigarettes-associated lung injuries has questioned the safety of these products. The E3 trial aimed at evaluating the efficacy and safety of e-cigarettes for smoking cessation in the general population.

The E3 trial, a multi-center randomized controlled trial, recruited participants motivated for smoking cessation. Individuals with severe diseases and a prognosis of less than a year, a current or recent history of cancer, a current or recent history of drug abuse or a recent history of cardiovascular or cerebrovascular disease, a history of psychiatric disorders and those using e-cigarettes or other medications for smoking cessation were excluded from the study. This resulted in 376 participants who were randomized into three management arms: nicotine ECs, non-nicotine ECs, or no e-cigarettes. All of them received individual counseling. Treatment allocation for ECs groups was double-blind. The treatment period was done for 12 weeks and individuals were followed for 52 weeks. Follow-up sessions were performed via phone interview (4 sessions) as well as in-person clinic visits (4 sessions). The primary endpoint was the comparison of nicotine-ECs with individual counseling in terms of biochemically-validated point-prevalence smoking abstinence at 12 weeks. The secondary endpoints included the evaluation of ECs efficacy in terms of continuous smoking abstinence and reduction in daily cigarette use as well as ECs safety profile.

In an interview with Dr. C. Michael Gibson, Dr. Mark J. Eisenberg, one of the investigators in the study, discussed the interim results of the study. Point-prevalence abstinence was higher for those who were treated with nicotine-ECs and counseling compared to those who only received counseling (22% versus 9%). In terms of safety, one of the individuals in nicotine-ECs developed COPD exacerbation, and 5 individuals in the non-nicotine ECs group also developed a variety of side effects including epistaxis and chest pain. The E3 trial is going to follow the patients for up to 1 year and the results of this study will be updated. This study will provide health care professionals, and smokers with important information regarding the efficacy and safety of e-cigarettes for smoking cessation.

Click here to listen to the discussion between Dr. C. Michael Gibson and Dr. Eisenberg.

Click here to view the study slides.