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CompletedNCT03612336ESTxENDSUpdated Nov 15, 2023

The ESTxENDS Trial- Substudy on the Metabolic Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)

An interventional study of ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in Smoking Cessation and Cardiovascular Diseases, sponsored by University of Bern. Completed at 5 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by University of Bern · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,246
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Metabolic outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.

Cardiovascular diseases (CVD) are a leading cause of death in cigarette smokers; quitting smoking is associated with reduced CVD. Cigarette smoking increases CVD through complex mechanisms, mostly on an increase in atherosclerosis and the effect appears unrelated to nicotine. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking. There is currently no evidence that ENDS use affects CVD outcomes. The nicotine contained in the e-liquids from ENDS has cardiovascular effects and the evidence about health effects mostly comes from studies on nicotine replacement therapy (NRT). These studies did not show an increased risk of CVD from NRTs. The ECLAT trial showed no difference in body weight, resting heart rate, or blood pressure between those who used ENDS or not. Two studies evaluated the short-term effects of ENDS on the cardiovascular system. One study suggested impairment in diastolic ventricular function with cigarettes and not with ENDS. Both ENDS and cigarettes increased diastolic blood pressure, potentially mediated through nicotine exposure, but an increased systolic blood pressure was found only in cigarette smokers. Other studies have suggested no changes in blood pressure in daily users of electronic cigarettes up to 1 year with some even a reduction in blood pressure among patients with hypertension. Interventions helping smokers quit have shown that quitting is associated with increased HDL-cholesterol, weight gain, higher blood glucose, and higher diabetes risk. No large randomized trials have tested the effect of ENDS on blood cholesterol and other markers of cardiovascular risk.

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.

For the main ESTxENDS trial (NCT03589989), 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. All participants will be followed over a 24-month period. Measurements of risk factors for cardiovascular diseases will be done at baseline and at 6, 12 and 24 months' follow-up.

02

Conditions studied

  • Smoking Cessation
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 1,246 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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 or tobacco heating systems 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,246 participants (actual)

Study arms

  • Experimental
    Intervention group

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

  • Active comparator
    Control group

    Other: Smoking cessation counseling

Interventions

  • OtherENDS (vaporizer/e-cig) and smoking cessation counseling

    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 24-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 and 24 months, participants will be asked to come to a clinical visit.

  • OtherSmoking cessation counseling

    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 24-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 and 24 months, participants will be asked to come to a clinical visit.

06

What researchers measure

Primary outcomes

  1. Measurements of risk factors for cardiovascular diseases (blood pressure)_1

    Measurement of blood pressure

    Time frame: 6 months post quit date

  2. Measurements of risk factors for cardiovascular diseases (blood pressure)_2

    Measurement of blood pressure

    Time frame: 12 months post quit date

  3. Measurements of risk factors for cardiovascular diseases (blood pressure)_3

    Measurement of blood pressure

    Time frame: 24 months post quit date

  4. Measurements of risk factors for cardiovascular diseases (heart rate)_1

    Measurement of heart rate

    Time frame: 6 months post quit date

  5. Measurements of risk factors for cardiovascular diseases (heart rate)_2

    Measurement of heart rate

    Time frame: 12 months post quit date

  6. Measurements of risk factors for cardiovascular diseases (heart rate)_3

    Measurement of heart rate

    Time frame: 24 months post quit date

  7. Measurements of risk factors for cardiovascular diseases (total cholesterol)_1

    Measurement of total cholesterol

    Time frame: 6 months post quit date

  8. Measurements of risk factors for cardiovascular diseases (total cholesterol)_2

    Measurement of total cholesterol

    Time frame: 12 months post quit date

  9. Measurements of risk factors for cardiovascular diseases (total cholesterol)_3

    Measurement of total cholesterol

    Time frame: 24 months post quit date

  10. Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_1

    Measurement of LDL-cholesterol

    Time frame: 6 months post quit date

  11. Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_2

    Measurement of LDL-cholesterol

    Time frame: 12 months post quit date

  12. Measurements of risk factors for cardiovascular diseases (LDL-cholesterol)_3

    Measurement of LDL-cholesterol

    Time frame: 24 months post quit date

  13. Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_1

    Measurement of HDL-cholesterol

    Time frame: 6 months post quit date

  14. Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_2

    Measurement of HDL-cholesterol

    Time frame: 12 months post quit date

  15. Measurements of risk factors for cardiovascular diseases (HDL-cholesterol)_3

    Measurement of HDL-cholesterol

    Time frame: 24 months post quit date

  16. Measurements of risk factors for cardiovascular diseases (triglycerides)_1

    Measurement of triglycerides

    Time frame: 6 months post quit date

  17. Measurements of risk factors for cardiovascular diseases (triglycerides)_2

    Measurement of triglycerides

    Time frame: 12 months post quit date

  18. Measurements of risk factors for cardiovascular diseases (triglycerides)_3

    Measurement of triglycerides

    Time frame: 24 months post quit date

  19. Measurements of risk factors for cardiovascular diseases (HbA1c)_1

    Measurement of HbA1c for persons with diagnosed diabetes

    Time frame: 6 months post quit date

  20. Measurements of risk factors for cardiovascular diseases (HbA1c)_2

    Measurement of HbA1c for persons with diagnosed diabetes

    Time frame: 12 months post quit date

  21. Measurements of risk factors for cardiovascular diseases (HbA1c)_3

    Measurement of HbA1c for persons with diagnosed diabetes

    Time frame: 24 months post quit date

  22. Measurements of risk factors for cardiovascular diseases (creatinine)_1

    Measurement of creatinine

    Time frame: 6 months post quit date

  23. Measurements of risk factors for cardiovascular diseases (creatinine)_2

    Measurement of creatinine

    Time frame: 12 months post quit date

  24. Measurements of risk factors for cardiovascular diseases (creatinine)_3

    Measurement of creatinine

    Time frame: 24 months post quit date

  25. Measurements of risk factors for cardiovascular diseases (waist circumference)_1

    Measurement of waist circumference

    Time frame: 6 months post quit date

  26. Measurements of risk factors for cardiovascular diseases (waist circumference)_2

    Measurement of waist circumference

    Time frame: 12 months post quit date

  27. Measurements of risk factors for cardiovascular diseases (waist circumference)_3

    Measurement of waist circumference

    Time frame: 24 months post quit date

  28. Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_1

    Measurements of weight and height to report BMI in kg/m\^2

    Time frame: 6 months post quit date

  29. Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_2

    Measurements of weight and height to report BMI in kg/m\^2

    Time frame: 12 months post quit date

  30. Measurements of risk factors for cardiovascular diseases (body mass index, BMI)_3

    Measurements of weight and height to report BMI in kg/m\^2

    Time frame: 24 months post quit date

Secondary outcomes

  1. Changes in cardiovascular disease risk factors (blood pressure)

    Measurement of blood pressure

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  2. Changes in cardiovascular disease risk factors (heart rate)

    Measurement of heart rate

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  3. Changes in cardiovascular disease risk factors (total cholesterol)

    Measurement of total cholesterol

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  4. Changes in cardiovascular disease risk factors (LDL-cholesterol)

    Measurement of LDL-cholesterol

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  5. Changes in cardiovascular disease risk factors (HDL- cholesterol)

    Measurement of HDL- cholesterol

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  6. Changes in cardiovascular disease risk factors (triglycerides)

    Measurement of triglycerides

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  7. Changes in cardiovascular disease risk factors (HbA1c)

    Measurement of HbA1c for persons with diagnosed diabetes

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  8. Changes in cardiovascular disease risk factors (creatinine)

    Measurement of creatinine

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  9. Changes in cardiovascular disease risk factors (waist circumference)

    Measurement of waist circumference

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  10. Changes in cardiovascular disease risk factors (body mass index, BMI)

    Measurements of weight and height to report BMI in kg/m\^2

    Time frame: Change from Baseline to 6,12, 24 months post quit date

  11. Physical activity

    Measured using the International Physical activity questionnaire (IPAQ). The short version (7 items) provides information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity.

    Time frame: 6,12, 24 months post quit date

  12. Changes of physical activity

    Measured using the International Physical activity questionnaire (IPAQ). The short version (7 items) provides information on the time spent walking, in vigorous- and moderate-intensity activity and in sedentary activity.

    Time frame: Change from Baseline to 6,12, 24 months post quit date

07

Study locations

5 sites
  • Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
    Lausanne, Vaud 1011, Switzerland
  • University Clinic for General Internal Medicine, Bern University Hospital
    Bern, 3010, Switzerland
  • Département de médecine interne, Hôpitaux universitaires de Genève
    Geneva, 1211, Switzerland
  • Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
    Saint Gallen, Switzerland
  • Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
    Zürich, Switzerland
08

References and documents

Publications

  • Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128. PubMed 23343063 ↗
  • Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397. PubMed 29630702 ↗
  • Benowitz NL, Fraiman JB. Cardiovascular effects of electronic cigarettes. Nat Rev Cardiol. 2017 Aug;14(8):447-456. doi: 10.1038/nrcardio.2017.36. Epub 2017 Mar 23. PubMed 28332500 ↗
  • 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. Erratum In: PLoS One. 2014;9(1). doi:10.1371/annotation/e12c22d3-a42b-455d-9100-6c7ee45d58d0. PubMed 23826093 ↗
  • Farsalinos KE, Tsiapras D, Kyrzopoulos S, Savvopoulou M, Voudris V. Acute effects of using an electronic nicotine-delivery device (electronic cigarette) on myocardial function: comparison with the effects of regular cigarettes. BMC Cardiovasc Disord. 2014 Jun 23;14:78. doi: 10.1186/1471-2261-14-78. PubMed 24958250 ↗
  • Farsalinos K, Cibella F, Caponnetto P, Campagna D, Morjaria JB, Battaglia E, Caruso M, Russo C, Polosa R. Effect of continuous smoking reduction and abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes. Intern Emerg Med. 2016 Feb;11(1):85-94. doi: 10.1007/s11739-015-1361-y. Epub 2016 Jan 9. PubMed 26749533 ↗
  • Oncken CA, Litt MD, McLaughlin LD, Burki NA. Nicotine concentrations with electronic cigarette use: effects of sex and flavor. Nicotine Tob Res. 2015 Apr;17(4):473-8. doi: 10.1093/ntr/ntu232. PubMed 25762758 ↗
  • Forey BA, Fry JS, Lee PN, Thornton AJ, Coombs KJ. The effect of quitting smoking on HDL-cholesterol - a review based on within-subject changes. Biomark Res. 2013 Sep 13;1(1):26. doi: 10.1186/2050-7771-1-26. PubMed 24252691 ↗
  • Aubin HJ, Farley A, Lycett D, Lahmek P, Aveyard P. Weight gain in smokers after quitting cigarettes: meta-analysis. BMJ. 2012 Jul 10;345:e4439. doi: 10.1136/bmj.e4439. PubMed 22782848 ↗
  • Stein JH, Asthana A, Smith SS, Piper ME, Loh WY, Fiore MC, Baker TB. Smoking cessation and the risk of diabetes mellitus and impaired fasting glucose: three-year outcomes after a quit attempt. PLoS One. 2014 Jun 3;9(6):e98278. doi: 10.1371/journal.pone.0098278. eCollection 2014. PubMed 24893290 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03612336
Lead sponsor
University of Bern
Collaborators
University of Lausanne, University of Geneva, Switzerland, University of Zurich, State Hospital, St. Gallen, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland, Federal Office of Public Health, Switzerland
Responsible party
Sponsor
First posted
Aug 2, 2018
Start date
Jul 16, 2018
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Nov 15, 2023

Study contacts

Reto Auer, Prof.Dr.med
study director · Berner Institut für Hausarztmedizin; Universität Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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