Research question
Cigarette smoking is the leading cause of preventable death in Switzerland. Recently, electronic nicotine delivery systems (ENDS or e-cigarettes) have become popular with smokers who want to switch from tobacco cigarettes to ENDS to reduce their exposure to toxic compounds or to stop smoking. Only a few rigorous RCTs have been published so far. They have promising, yet inconclusive results, as they were based on small samples. The safety and potential adverse effects of ENDS are also largely unknown.
The objectives of this study are to test the efficacy of ENDS for cigarette smoking cessation, test the safety of ENDS on adverse events and the effect of ENDS on reducing exposure to inhaled toxic compounds as well as on health-related outcomes (respiratory symptoms, oxidative stress, risk factors for heart disease). The ongoing extension of follow-up to 60-month represents the longest follow-up on the health outcomes of participants to such a trial.
Aim of the study
The study aims to assess the efficacy, safety and toxicology of ENDS for helping smokers quit smoking.
Procedure
At random, half of the participants received an E-cigarette (Vaporizer) with nicotine-containing e-liquids for 6 months and smoking cessation counselling. The second half of the participants (control group) received smoking cessation counselling only. To observe long-term outcomes we follow the participants in regular clinical visits at 6-, 12-, 24- and 60-months.
Duration
A total of 5 clinical visits (90 or 60 minutes) and 4 follow up phone calls (15 minutes) took place over 60 months. During clinical visits, personal data are recorded, measurements are made and questionnaires are filled out. All data will be kept confidential. The main results of the 6-month intervention trial have already been published and are available on our website. In addition, participants had the opportunity to undergo lung function testing and magnetic resonance imaging (MRI). The results of the MRI study have also been published on the ESTxENDS website. We are currently analysing the data from the 12- and 24-month follow-up assessments. The 60-month follow-up visits are currently ongoing and are expected to be completed by June 2026.
Overview
