The ESTxENDS Trial- Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation-extension of Follow-up

NCT04236791 | Active Not Recruiting DMC

• 1 other identifier: 2017-02332_2
• Study Type: interventional
• Target: 1,246
• Locations: 1 country
• Sites: 5

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (4)

• Validated 7-day point prevalence abstinence (1)

  Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO).

  6 months post quit date

• Validated 7-day point prevalence abstinence (1.1)

  Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO).

  12 months post quit date

• Validated 7-day point prevalence abstinence (2)

  Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO).

  24 months post quit date

• Validated 7-day point prevalence abstinence (2.1)

  Confirmation of having smoked no cigarettes in the past seven days, validated by urinary levels of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol). If NNAL is missing, validation by urinary levels of anabasine or exhaled carbon monoxide (CO).

  60 months post quit date

Secondary Outcomes (17)

• Self-reported 7-day point prevalence abstinence

  12, 24 and 60 months post quit date

• Continuous smoking abstinence

  12, 24 and 60 months post quit date

• Continuous smoking abstinence (2)

  12, 24 and 60 months post quit date

• Self-reported smoking abstinence allowing a 2-week'grace period'

  12, 24 and 60 months post quit date

• Validated smoking abstinence allowing a 2-week'grace period' (1)

  12, 24 and 60 months post quit date

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will received the Innokin Endura T20-S starter kit as intervention device. We use the e-liquids produced by the company Gaïatrend in France. Nicotine concentrations available will be 0 mg/ml, 6 mg/ml, 11 mg/ml and 19.6 mg/ml. Following aromas will be available to be chosen by the study participants: FR-4 (tobacco flavor) and FR-M (tobacco flavor), FRESH MINT (menthol flavor), RASPBERRY#2 (fruity flavor), RED FRUITS (fruity flavor) or GREEN APPLE (fruity flavor). The proportion of propylene glycol and vegetal glycerin will be 76/24 for all e-liquids. The components of the e-liquids will be propylene glycol, vegetal glycerin, medical-quality nicotine, alcohol and aromas.

Other: ENDS (vaporizer/e-cig) and smoking cessation counseling

Control group

ACTIVE COMPARATOR

Participants in the control intervention will receive standard-of-care (SOC) in form of smoking cessation counseling (SCC) only.

Other: Smoking cessation counseling

Interventions

ENDS (vaporizer/e-cig) and smoking cessation counseling OTHER

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 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 one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12, 24 and 60 months, participants will be asked to come to a clinical visit.

Intervention group

Smoking cessation counseling OTHER

Participants in the control group will receive smoking cessation counseling only. Participants 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 one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12, 24 and 60 months, participants will be asked to come to a clinical visit.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• University of Lausanne: collaborator
• University of Geneva, Switzerland: collaborator
• University of Zurich: collaborator
• State Hospital, St. Gallen: collaborator
• Swiss National Science Foundation: collaborator
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• Federal Office of Public Health, Switzerland: collaborator

Study Sites (5)

Policlinique Médicale Universitaire, Université de Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

University Clinic for General Internal Medicine, Bern University Hospital

Bern, 3010, Switzerland

Location

Département de médecine interne, Hôpitaux universitaires de Genève

Geneva, 1211, Switzerland

Location

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich

Zurich, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 24029165 BACKGROUND

• 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.

  PMID: 23826093 BACKGROUND

• 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.

  PMID: 27622384 BACKGROUND

• 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.

  PMID: 27113014 BACKGROUND

• 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.

  PMID: 25083263 BACKGROUND

• 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.

  PMID: 1932883 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Reto Auer, Prof.Dr.med.

  Berner Institut für Hausarztmedizin; Universität Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statisticians and laboratory personnel will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 22, 2020
• Study Start: July 16, 2018
• Primary Completion: August 31, 2023
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CH (5)