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Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol
  1. Ivan Berlin1,2,
  2. Bertrand Dautzenberg1,
  3. Blandine Lehmann3,
  4. Jessica Palmyre4,
  5. Emmanuelle Liégey5,
  6. Yann De Rycke6,
  7. Florence Tubach6,7
  1. 1 Département de pharmacologie, Hôpital Universitaire Pitié Salpêtrière, Paris, France
  2. 2 CHUV, Centre Universitaire de Médecine Générale et Santé Publique, Lausanne, Switzerland
  3. 3 Agence générale des équipements et produits de santé, Assistance Publique—Hopitaux de Paris, Paris, France
  4. 4 Unité de Recherche Clinique, Assistance Publique—Hopitaux de Paris, Paris, France
  5. 5 Délégation à la Recherche Clinique et à l’Innovation, Assistance publique—Hôpitaux de Paris, Paris, France
  6. 6 Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), INSERM, AP-HP, Hôpital Pitié-Salpêtrière, Paris, France
  7. 7 INSERM, UMR 1123, Sorbonne Université, Faculté de médecine Sorbonne Université, Paris, France
  1. Correspondence to Dr Ivan Berlin; ivan.berlin{at}aphp.fr

Abstract

Introduction Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking.

Methods and analysis Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18–70 years. Interventions: (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition, (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. Flavour: blond tobacco. (C) Reference: ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorisationauthorisation. Treatment duration: 1 week+3 months. Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9–12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. Secondary outcomes: safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline.

Ethics and dissemination The ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions.

Trial registration number NCT03630614; Pre-results.

  • electronic cigarettes
  • varenicline
  • smoking cessation
  • randomised, controlled, double dummy trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Concept and design: IB, BD. Drafting of the manuscript: IB. Critical revision of the manuscript for important intellectual content: BD, BL, YDR, FT, JP, EL. Administrative, technical, material support: BL, JP, EL.

  • Funding This work was supported by the Programme Hospitalier de Recherche Clinique (PHRC) National 2015: AOM15002, Ministry of Health, France

  • Competing interests IB reports occasional honoraria from Pfizer in the last 3 years for counseling and presentations at meetings. FT is head of the clinical research unit of Pitié-Salpêtrière and Charles Foix hospitals and the pharmacoepidemiology center of Assistance Publique Hôpitaux de Paris, that have received research funding, grants and fees for consultant activities from a large number of pharmaceutical companies, that have contributed indiscriminately to the salaries of its employees. She did not receive any personal remuneration from these companies.

  • Ethics approval The ethics committee (Comité de protection des personnes, CPP) Ouest II-Angers, France, approved this protocol on 17 April 2018.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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