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Smoking CessationESTxENDSNCT03589989

The ESTxENDS Trial- Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cigarette) as an Aid for Smoking Cessation.

A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation, run by University of Bern at 5 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,246 participants
Where
5 sitesSwitzerland
Study dates
16 Jul 2018to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Switzerland5 sites

  • University Clinic for General Internal Medicine, Bern University Hospital

    Bern, 3010

  • Département de médecine interne, Hôpitaux universitaires de Genève

    Geneva, 1211

  • Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne

    Lausanne, Canton of Vaud, 1011

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

    Sankt Gallen

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

    Zurich

Other trials in Switzerland

About this study

Official title: Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial)

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.

Read more

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 6-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 months, participants will be asked to come to a final clinical visit.

Being tested
ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENDS (vaporizer/e-cig) and smoking cessation counselingOther

    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 6-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 months, participants will be asked to come to a final clinical visit.

  • Smoking cessation counselingOther

    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 6-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 months, participants will be asked to come to a final clinical visit.

Study groups in NCT03589989
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling
Control groupActive comparatorNot described
Receives: Other: Smoking cessation counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous smoking abstinence (1)

    Self-report of having smoked no cigarettes from quit date, validated by urinary levels of anabasine. If anabasine is missing, validation by exhaled carbon monoxide (CO).

    Measured: 6 months post quit date

Secondary outcomes (18)

  1. Continuous smoking abstinence (2)

    Self-report of having smoked no cigarettes from quit date, 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).

    Measured: 6 months post quit date

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

    Smoking abstinence allowing a 2-week'grace period' after the target quit date.

    Measured: 4, 8 weeks and 6 months post quit date

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

    Smoking abstinence allowing a 2-week'grace period' after the target quit date, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO).

    Measured: 6 months post quit date

  4. Validated smoking abstinence allowing a 2-week'grace period' (2)

    Smoking abstinence allowing a 2-week'grace period' after the target quit date, 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).

    Measured: 6 months post quit date

  5. Self-reported smoking abstinence allowing up to 5 cigarettes

    Smoking abstinence allowing up to 5 cigarettes in total after the target quit date.

    Measured: 1, 2, 4, 8 weeks and 6 months post quit date

  6. Validated smoking abstinence allowing up to 5 cigarettes (1)

    Smoking abstinence allowing up to 5 cigarettes in total after the target quit date, validated by urinary levels of anabasine. If anabasine is missing validation by exhaled carbon monoxide (CO).

    Measured: 6 months post quit date

  7. Validated smoking abstinence allowing up to 5 cigarettes (2)

    Smoking abstinence allowing up to 5 cigarettes in total after the target quit date, 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).

    Measured: 6 months post quit date

  8. Self-reported 7-day point prevalence abstinence

    Self-report of having smoked no cigarettes in the past seven days.

    Measured: 1, 2, 4, 8 weeks and 6 months post quit date

  9. 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).

    Measured: 6 months post quit date

  10. 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).

    Measured: 6 months post quit date

  11. Number of cigarettes smoked per day (CPD)

    self-reported

    Measured: baseline, target quit date, 1, 2, 4, 8 weeks and 6 months post quit date

  12. Change in number of cigarettes smoked per day (CPD)

    self-reported. Successful reduction defined as 50% reduction in CPD.

    Measured: baseline, 6 months post quit date

  13. Use of any other smoking cessation products (NRT, Nicotine replacement therapy)

    self-reported on whether and how often they used any NRT.

    Measured: 1, 2, 4, 8 weeks and 6 months post quit date

  14. Withdrawal

    The physical signs and symptoms associated with withdrawal, measured using the Minnesota Tobacco Withdrawal Scale (http://www.med.uvm.edu/behaviorandhealth/minnwsdefault). The Minnesota Tobacco Withdrawal Scale measures self-reported severity of nicotine withdrawal. The measure has 15 items, with five possible responses (0-5), thus scores on the scale range from 0 to 60.

    Measured: baseline and 6 months post quit date

  15. Nicotine dependence

    Nicotine dependence measured using the Fagerström Test. The Fagerström Test for Nicotine Dependence (FTND, Heatherton TF et al., 1991) is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. Two items have four possible responses (0-3) and four items have two possible responses (0-1). The nicotine dependence score ranges from 0 to 10. A score between 0 and 2 is considered as a low nicotine dependence, a score between 3 to 5 is considered as a medium nicotine dependence, a score between 6 and 7 is considered as a high nicotine dependence and a score between 8 and 10 is considered as a very high nicotine dependence.

    Measured: baseline and 6 months post quit date

  16. Health-related quality of life

    Measured using the Swiss EQ-5D. The EQ-5D questionnaire is a standardized measure of health status developed by the EuroQol Group (https://euroqol.org/). EQ-5D questionnaires have five dimensions: "Mobility", "Self-care," "Usual Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by five problem levels corresponding to participant response choices.

    Measured: baseline and 6 months post quit date

  17. Use of any ENDS

    self-reported on whether and how often they used any ENDS

    Measured: 1, 2, 4, 8 weeks and 6 months post quit date

  18. Report on most common adverse events using ENDS

    Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of ENDS, whether or not it is considered related to the product.

    Measured: 1, 2, 4, 8 weeks and 6 months post quit date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start16 Jul 2018
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589989
Sponsor's protocol ID
2017-02332
Other IDs
2017
Acronym
ESTxENDS
Status last verified
May 2022
First submitted
19 Jun 2018
Last updated
18 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24029165

  • 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.

    PubMed 23826093

  • 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.

    PubMed 27622384

  • 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.

    PubMed 27113014

  • 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.

    PubMed 25083263

  • 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.

    PubMed 1932883

  • Auer R, Schoeni A, Humair JP, Jacot-Sadowski I, Berlin I, Stuber MJ, Haller ML, Tango RC, Frei A, Strassmann A, Bruggmann P, Baty F, Brutsche M, Tal K, Baggio S, Jakob J, Sambiagio N, Hopf NB, Feller M, Rodondi N, Berthet A. Electronic Nicotine-Delivery Systems for Smoking Cessation. N Engl J Med. 2024 Feb 15;390(7):601-610. doi: 10.1056/NEJMoa2308815.

    PubMed 38354139

  • Nyilas S, Bauman G, Korten I, Pusterla O, Singer F, Ith M, Groen C, Schoeni A, Heverhagen JT, Christe A, Rodondi N, Bieri O, Geiser T, Auer R, Funke-Chambour M, Ebner L. MRI Shows Lung Perfusion Changes after Vaping and Smoking. Radiology. 2022 Jul;304(1):195-204. doi: 10.1148/radiol.211327. Epub 2022 Apr 5.

    PubMed 35380498

Questions about this trial

What is this clinical trial studying?

A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation, run by University of Bern at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous smoking abstinence (1) (time frame: 6 months post quit date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589989, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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