NCT02417467

Trial name or title	Evaluating the efficacy of e‐cigarette use for smoking cessation (E3) Trial
Methods	Randomized parallel‐assignment double‐blind trial Setting: community, Canada Recruitment: motivated volunteers
Participants	Estimated enrolment: 486 Inclusion criteria: Active smoker, 10+ cpd, on average, for the past year; Aged 18 years or older; Motivated to quit according to the Motivation To Stop Scale (MTSS) (level 5 or higher). Exclude if: Medical condition with a prognosis < 1 year; Current or recent cancer (< 1 year in remission); Pregnant or lactating women; Current or recent use (in the past 30 days) of any pharmacotherapy or behavioural therapy for smoking cessation (e.g. Nicotine Replacement Therapies, bupropion, varenicline, or counselling); Any EC use (nicotine or non‐nicotine) in the past 60 days, or ever use of any EC for > 7 days consecutively; History of psychosis, schizophrenia, or bipolar disorder; < 1 month following a myocardial infarction, life‐threatening arrhythmia, severe or worsening angina pectoris, or cerebral vascular accident; Use of any illegal drugs in the past year (excluding marijuana); Planned use of tobacco products other than conventional cigarettes (e.g. cigarillos, cigars, snuff, shisha, etc.) or marijuana during the study period.
Interventions	Smoking cessation/relapse prevention counselling will be provided for all participants for a minimum of 30 minutes at baseline, 10 minutes during telephone follow‐ups, and 15 minutes at clinic visits (20 minutes at week 4). Counselling will consist of a number of approaches, including reviewing smoking history, development/revision of a quit plan, encouragement of self‐monitoring, review of triggers and challenges, and skill development. 1) Nicotine‐containing EC 2) Non‐nicotine EC 3) Counselling only
Outcomes	At 4, 12, 24 and 52 weeks: Primary: PP abstinence Secondary: multiple PP and continuous abstinence, change in cig consumption. Adverse events and dropouts (at 12 weeks)
Starting date	September 2016
Contact information	Mark Eisenberg
Notes