ESTxENDS

Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an aid for smoking cessation: The ESTxENDS multicentre randomized controlled trial

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 two 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).

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 will receive an E-cigarette (Vaporizer) with nicotine-containing e-liquids and smoking cessation counselling. The second half of the participants (control group) receive smoking cessation counselling only.

Duration

A total of 4 clinical visits (90 or 60 minutes) and 4 follow up phone calls (15 minutes) take place over 24 months. During clinical visits, personal data are recorded, measurements are made and questionnaires are filled out. All data will be kept confidential. No personal benefit can be guaranteed for the participants. It is additionally possible to take part in a lung function measurement and an MRI (magnetic resonance imaging) measurement. The study team will inform you with pleasure.

Compensation

All examinations as part of the study are free. The E-cigarette and the remaining e-liquids can be retained, respectively participants in the control group receive a BERNcity voucher worth CHF50.-. All participants will receive a BERNcity voucher worth CHF30.- after 12 and 24 months. If you are interested in participating, please contact the study team.

Study participation

https://www.estxends.ch/ contact: +41 31 632 00 69 or rauchstoppstudie@insel.ch

Overview

Project leader Prof. Dr. med Reto Auer
Project team
Dr. phil. Anna Schöni
Dr. phil. Micheline Maire
Cindy Groen
Doctoral student Cand Dr. Nicolas Sambiagio, Institut de Santé au Travail (IST), Lausanne
Co-Investigators Prof. Dr. med. Nicolas Rodondi, BIHAM
Prof. Dr. med. Jacques Cornuz, PMU Lausanne
PD Dr. med. Nancy Hopf, IST Lausanne
PD Dr. med. Jean-Paul Humair, Service de médecine de premier recours, HUG, Genève
Partners PD Dr. med. Sven Trelle, CTU Bern
Dr. Aurélie Berthet, IST Lausanne
Dr. Jean-Jacques Sauvain, IST Lausanne
Dr. med. Isabelle Jacot-Sadowski, PMU Lausanne
PD Dr. med. Carole Clair, PMU Lausanne
Scientific Advisors Prof. Dr. med. Ivan Berlin, Paris
Prof. Dr. med. Jean-François Etter, Geneva
Prof. Dr. med. Konstantinos Farsalinos
Funders SNF Investigator Initiated Clinical Trials
Tobacco Prevention Fund
Swiss cancer research
Study design
Randomised-controlled multicenter clinical Trial
Study start June 2017
External link
http://p3.snf.ch/project-173552
ESTxENDS Study https://www.estxends.ch/
TV-Show "10-to-10"
https://www.srf.ch/news/schweiz/schweizer-studie-lanciert-wie-gefaehrlich-sind-e-zigaretten
TV-Show "Puls"
https://www.srf.ch/news/schweiz/umstrittenes-dampfen-e-zigaretten-als-ausstiegshilfe-oder-einstiegsdroge
UniAktuell https://www.uniaktuell.unibe.ch/2018/rauchst_du_noch_oder_dampfst_du_schon/index_ger.html