a Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

Introduction:
This text provides an overview of the Evaluating the Efficacy of E-Cigarette (E3) use for Smoking Cessation trial, a randomized controlled trial (RCT) designed to evaluate the efficacy of e-cigarettes for smoking cessation in the general population. The trial design, methods, and key considerations are discussed.

Key Points:

* The E3 trial is a multicentre, three-arm RCT with a treatment period of 12 weeks and follow-up of 52 weeks, involving 376 participants.
* Participants were randomized to nicotine e-cigarettes with individual counselling, non-nicotine e-cigarettes with individual counselling, or individual counselling alone.
* The primary objective is to compare the efficacy of nicotine and non-nicotine e-cigarettes, combined with individual counselling, with that of individual counselling alone, in terms of biochemically validated smoking abstinence at 12 weeks.
* Participants were recruited through community-based advertisements, online platforms, and healthcare clinics.
* Informed consent, eligibility, and randomization were conducted by non-investigator research personnel, with participants blinded to nicotine content in the e-cigarette groups.
* Interventions included individual smoking cessation/relapse prevention counselling for all groups, with e-cigarette groups receiving a rechargeable device and tobacco-flavored cartridge refills.
* Follow-ups were conducted via telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52.
* The trial aims to provide regulators, healthcare professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.

Main Message:
The E3 trial is a rigorously designed RCT that aims to address the efficacy and safety of e-cigarettes for smoking cessation in the general population. By comparing nicotine and non-nicotine e-cigarettes with individual counselling, the trial will offer valuable insights for regulators, healthcare professionals, and smokers looking to quit. Given the ongoing debate about e-cigarette safety and their role in smoking cessation, the results of this trial will be crucial for informing policy and practice.

hébert-Losier a, Filion KB, Windle SB, Eisenberg MJ. a Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design. CJC open. 2020;2(3):168-175. doi:10.1016/j.cjco.2020.03.006