Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an aid for smoking cessation: The ESTxENDS multicentre randomized controlled trial
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.
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.
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.
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.
|Project leader||Prof. Dr. med Reto Auer|
Dr. phil. Anna Schöni
Dr. phil. Micheline Maire
Cand Dr. Nicolas Sambiagio, Institut de Santé au Travail (IST), Lausanne
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
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
Prof. Dr. med. Ivan Berlin, Paris
Prof. Dr. med. Jean-François Etter, Geneva
Prof. Dr. med. Konstantinos Farsalinos
SNF Investigator Initiated Clinical Trials
Tobacco Prevention Fund
Swiss cancer research
||Randomised-controlled multicenter clinical Trial|
|Study start||June 2017|