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

English title Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an aid for smoking cessation: The ESTxENS multicentre randomized controlled trial
Applicant Auer Reto
Number 173552
Funding scheme Investigator Initiated Clinical Trials (IICT)
Research institution Berner Institut für Hausarztmedizin BIHAM Universität Bern
Institution of higher education University of Berne - BE
Main discipline Addictive Diseases
Start/End 01.06.2017 - 30.06.2021
Approved amount 1'897'332.00
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Keywords (8)

toxic inhaled compounds; smoking cessation; nicotine; randomized controlled trial; oxidative stress; safety; tobacco; electronic nicotine delivery devices (ENDS)

Lay Summary (French)

Lead
Le tabagisme est la principale cause de décès évitable en Suisse. Les vapoteuses (aussi appelées cigarettes électroniques) sont de plus en plus utilisées par des personnes fumeuses qui veulent réduire leur exposition à des composés toxiques ou arrêter de fumer en passant des cigarettes de tabac à la vapoteuse. Or nous ne savons pas encore si les vapoteuses sont un moyen efficace et sûr pour arrêter de fumer. Nous inclurons 1172 fumeu-ses-rs dans un essai clinique contrôlé randomisé qui comparera des conseils d’aide à l’arrêt du tabac combiné à la distribution de vapoteuse à des conseils d’aide à l’arrêt seul. Notre étude permettra aux utilisat-rices-eurs, aux décideu-ses-rs et aux professionnel-le-s de la santé d’avoir des informations rigoureuses et indépendantes sur l’efficacité, la sécurité et la toxicité des vapoteuses pour arrêter de fumer ou comme alternative à la consommation de cigarettes de tabac.
Lay summary

Objectifs du projet:

Nous allons tester l'efficacité de vapoteuses pour l'arrêt du tabagisme et la réduction du nombre de cigarettes fumées après 6 mois de suivi. Nous allons tester la sécurité des vapoteuses en mesurant les effets indésirables. Nous verrons également si la vapoteuse réduit l'exposition à des composés toxiques inhalés et si elle améliore des mesures en lien avec la santé comme les symptômes respiratoires et des mesures dans le sang et l'urine, comme le stress oxydatif et les facteurs de risque de maladie cardiaque.

Contexte scientifique et sociétal du projet de recherche:

Deux essais cliniques randomisés rigoureux ont déjà été publiés. Leurs résultats au sujet de l’efficacité sont prometteurs, mais peu concluants, puisque peu de personnes ont été incluses dans ces études. La sécurité et les effets négatifs potentiels des vapoteuses sont encore très peu connus. Nous cherchons à résoudre une controverse parmi les professionnels de la santé et les décideurs politiques. Certains préconisent d’encourager activement l’utilisation de vapoteuses car elles représenteraient une alternative sûre aux cigarettes de tabac ; d’autres pensent qu’il faudrait décourager l’utilisation de vapoteuses car elles pourraient nuire à la santé des utilisateurs et les décourager les utilisateurs d’arrêter de fumer. Nous voulons déterminer si les vapoteuses sont un moyen efficace et sûr pour arrêter de fumer et si elles permettraient de sauver de nombreuses vies perdues à cause du tabac. Notre étude aidera les utilisat-rice-eur-s, les décideu-se-r-s et les professionnel-le-s de la santé décider s’il faut pour promouvoir activement les vapoteuses comme alternative aux cigarettes de tabac.

Direct link to Lay Summary Last update: 13.07.2018

Responsible applicant and co-applicants

Employees

Project partner

Collaboration

Group / person Country
Types of collaboration
University of California San Francisco United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
The University of Auckland New Zealand (Oceania)
- in-depth/constructive exchanges on approaches, methods or results

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Lungentag 2018, Insel Pneumologie-BIHAM Talk given at a conference Doktor, was halten Sie von Verdampfer (E-Zigaretten) zur Rauchentwöhnung? 28.06.2018 Bern, Switzerland Auer Reto;
SGHC/SSCC 2018 Talk given at a conference E-Cigarettes aka Nicotine Vaporizers: Curse or blessing? 08.06.2018 Basel, Switzerland Auer Reto;


Knowledge transfer events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Gesundheitsmittwoch - Parlamentary session Talk 12.12.2018 Bern, Switzerland
Association des Acteurs de Lorrains en Tabacologie Talk 07.12.2018 Nancy, France
AT Tagung 2018 Workshop 28.11.2018 Bern, Switzerland
AT Tagung 2018 Talk 28.11.2018 Bern, Switzerland
Entlebucher Tagung Talk 07.09.2018 Luzern, Switzerland
Mitgliederversammlung vom Trägerverein der Volksinitiative «Ja zum Schutz der Kinder und Jugendlichen vor Tabakwerbung» Talk 14.08.2018 Bern, Switzerland
Praxisupdate 2018 Workshop 08.03.2018 Bern, Switzerland


Communication with the public

Communication Title Media Place Year
Talks/events/exhibitions Produits de remplacement de la nicotine Western Switzerland 2018
Media relations: radio, television TeleBielingue TeleBielingue German-speaking Switzerland 2018
Talks/events/exhibitions VapeCon Switzerland Western Switzerland German-speaking Switzerland 2018

Abstract

Background: 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. While the aerosol the users inhale appears safe in laboratory conditions, the difference in exposure to toxins (such as measures exposure to organic compounds) and effect of toxins on the body (measures of oxidative stress) between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in an RCT. Objectives: Test ENDS on: 1) the efficacy for cigarette smoking cessation and reducing the number of cigarettes smoked over 6 months of follow-up; 2) the safety of ENDS on adverse events; 3) the effect of ENDS on reducing exposure to inhaled toxic compounds; 4) the effect of ENDS on health-related outcomes (clinical outcomes: respiratory symptoms; surrogate outcomes: oxidative stress, risk factors for heart disease).Hypotheses: ENDS are a safe alternative to cigarette smoking. They help smokers quit smoking, reduce their exposure to toxic compounds released by tobacco cigarettes, and improve markers of oxidative stress and risk factors for heart disease and respiratory symptoms.Methods: We plan to include 1172 smokers in a pragmatic RCT that will add ENDS to smoking cessation counselling (SCC), and compare ENDS to SCC alone. Our main outcome will be continuous smoking cessation after target quit date at 6-month follow-up, with blinded assessment and biochemical verification by exhaled carbon monoxide (CO) and urinary anabasine levels. In intention to treat analyses, assuming a 5% lost to follow-up, we will have 90% power at two sided a of 5% of detecting a 7% absolute increase in smoking cessation rate (from 12% to 19%, RR 1.6, assuming ENDS are as efficacious as nicotine replacement therapy (NRTs) plus SSC. Participants in the intervention arm will receive free ENDS, nicotine-containing e-liquids ad libitum, and technical support for using ENDS. Participants in both arms will receive SCC in four sessions over two months over the phone, and be allowed to use NRTs and other smoking cessation help. In order to minimize attrition in the control group, we will provide members with the intervention after the 6-month follow-up visit. At baseline and 6-month follow-up, we will distribute questionnaires and perform a battery of clinical tests, including tests for cardiovascular risk factors (blood pressure, lipids, and glucose; body mass index), determine urinary biomarkers for tobacco-specific nitrosamines (TSNAs), nicotine metabolites (nicotine, cotinine, anabasine), NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), metabolites of polycyclic aromatic hydrocarbons (PAHs) (1-hydroxypyrene, 1-and 2-naphthol) and oxidative stress markers in urine (8-hydroxy-2'-deoxyguanosine and 8-iso-prostaglandin F22a).Working group: This is a collaboration between clinicians expert both in conducting RCTs in smoking cessation and treating smokers in the community and experts in measuring pollutants and their effects in humans. Significance: Despite the wide use of ENDS, efficacy for smoking cessation and safety is uncertain and no published RCTs have evaluated the toxicity of ENDS. For objectivity, these outcomes should be assessed independently from the tobacco and ENDS industry. We will provide users, health care providers, and policy makers with evidence to support smoking cessation counselling, and shape ENDS regulation on the national and international level.
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