Clinical trial NCT04236791: The ESTxENDS Trial- Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation-extension of Follow-up
Official title: Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial)- Extension of Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: University of Geneva, Switzerland
name: University of Zurich
name: State Hospital, St. Gallen
name: Swiss National Science Foundation
name: Krebsforschung Schweiz, Bern, Switzerland
name: Federal Office of Public Health, Switzerland
First posted: 2020-01-22
Enrollment: 1246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Only two rigorous randomized controlled trials (RCTs) on the efficacy of ENDS to help smokers quit have been published so far. They have promising, yet inconclusive results, as the number of included participants were small. 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 chemicals (such as reduction in exposure to volatile organic compounds) and effects of chemicals on the body (adverse events, improved health-related outcomes and 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.

This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals.

The primary hypothesis of this trial is that providing cigarette smokers willing to quit smoking tobacco cigarettes with ENDS leads to a higher rate of smokers who quit cigarette smoking than only smoking cessation counseling with nicotine replacement therapy (NRT), which represents nowadays the standard of care. For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. Participants in both groups will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 60-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. After 6,12, 24, 60 months, participants will be asked to come to a clinical visit.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Persons aged 18 or older
* Currently smoking 5 or more cigarettes a day for at least 12 months
* Willing to try to quit smoking within the next 3 months,
* Persons providing a valid phone number, a valid email address and/or a valid postal address.

Exclusion Criteria:

* Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
* Persons having used ENDS regularly in the 3 months preceding the baseline visit
* Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
* Persons who cannot attend the 6- month follow-up visit for any reason
* Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures

Primary outcomes:
measure: Validated 7-day point prevalence abstinence (1)
timeFrame: 6 months post quit date
measure: Validated 7-day point prevalence abstinence (1.1)
timeFrame: 12 months post quit date
measure: Validated 7-day point prevalence abstinence (2)
timeFrame: 24 months post quit date
measure: Validated 7-day point prevalence abstinence (2.1)
timeFrame: 60 months post quit date
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence
timeFrame: 12, 24 and 60 months post quit date
measure: Continuous smoking abstinence
timeFrame: 12, 24 and 60 months post quit date
measure: Continuous smoking abstinence (2)
timeFrame: 12, 24 and 60 months post quit date
measure: Self-reported smoking abstinence allowing a 2-week'grace period'
timeFrame: 12, 24 and 60 months post quit date
measure: Validated smoking abstinence allowing a 2-week'grace period' (1)
timeFrame: 12, 24 and 60 months post quit date
measure: Validated smoking abstinence allowing a 2-week'grace period' (2)
timeFrame: 12, 24 and 60 months post quit date
measure: Self-reported smoking abstinence allowing up to 5 cigarettes
timeFrame: 12, 24 and 60 months post quit date
measure: Validated smoking abstinence allowing up to 5 cigarettes (1)
timeFrame: 12, 24 and 60 months post quit date
measure: Validated smoking abstinence allowing up to 5 cigarettes (2)
timeFrame: 12, 24 and 60 months post quit date
measure: Number of cigarettes smoked per day (CPD)
timeFrame: 12, 24 and 60 months post quit date
measure: Change in number of cigarettes smoked per day (CPD)
timeFrame: 12, 24 and 60 months post quit date
measure: Use of any other smoking cessation products (NRT, Nicotine replacement therapy)
timeFrame: 12, 24 and 60 months post quit date
measure: Withdrawal
timeFrame: 12, 24 and 60 months post quit date
measure: Nicotine dependence
timeFrame: 12, 24 and 60 months post quit date
measure: Health-related quality of life
timeFrame: 12, 24 and 60 months post quit date
measure: Use of any ENDS
timeFrame: 12, 24 and 60 months post quit date
measure: Report on most common adverse events using ENDS
timeFrame: 12, 24 and 60 months post quit date
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Policlinique Médicale Universitaire, Université de Lausanne
state: Vaud
city: Bern
country: Switzerland
facility: University Clinic for General Internal Medicine, Bern University Hospital
city: Geneva
country: Switzerland
facility: Département de médecine interne, Hôpitaux universitaires de Genève
city: Saint-Gall
country: Switzerland
facility: Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
Study officials:
affiliation: Berner Institut für Hausarztmedizin; Universität Bern
name: Reto Auer, Prof.Dr.med.
role: STUDY_DIRECTOR
References:
citation: Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9.
citation: Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013.
citation: Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, Stead LF, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2016 Sep 14;9(9):CD010216. doi: 10.1002/14651858.CD010216.pub3.
citation: Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, Andrews J, Zawertailo L, Ferrence R. Electronic Cigarettes for Smoking Cessation: A Systematic Review. Nicotine Tob Res. 2016 Oct;18(10):1926-1936. doi: 10.1093/ntr/ntw119. Epub 2016 Apr 25.
citation: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430.
citation: Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.