AzTrials
AzTrials

Smoking CessationESTxENDSNCT03612336

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

A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Cardiovascular Diseases, 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

--> 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. 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, Cardiovascular Diseases
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 31 Aug 2023
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 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

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: Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Metabolic Substudy of ESTxENDS

--> 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.

Read more

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.

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

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 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.

  • 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 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.

Study groups in NCT03612336
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. Measurements of risk factors for cardiovascular diseases (blood pressure)_1

    Measurement of blood pressure

    Measured: 6 months post quit date

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

    Measurement of blood pressure

    Measured: 12 months post quit date

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

    Measurement of blood pressure

    Measured: 24 months post quit date

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

    Measurement of heart rate

    Measured: 6 months post quit date

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

    Measurement of heart rate

    Measured: 12 months post quit date

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

    Measurement of heart rate

    Measured: 24 months post quit date

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

    Measurement of total cholesterol

    Measured: 6 months post quit date

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

    Measurement of total cholesterol

    Measured: 12 months post quit date

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

    Measurement of total cholesterol

    Measured: 24 months post quit date

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

    Measurement of LDL-cholesterol

    Measured: 6 months post quit date

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

    Measurement of LDL-cholesterol

    Measured: 12 months post quit date

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

    Measurement of LDL-cholesterol

    Measured: 24 months post quit date

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

    Measurement of HDL-cholesterol

    Measured: 6 months post quit date

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

    Measurement of HDL-cholesterol

    Measured: 12 months post quit date

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

    Measurement of HDL-cholesterol

    Measured: 24 months post quit date

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

    Measurement of triglycerides

    Measured: 6 months post quit date

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

    Measurement of triglycerides

    Measured: 12 months post quit date

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

    Measurement of triglycerides

    Measured: 24 months post quit date

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

    Measurement of HbA1c for persons with diagnosed diabetes

    Measured: 6 months post quit date

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

    Measurement of HbA1c for persons with diagnosed diabetes

    Measured: 12 months post quit date

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

    Measurement of HbA1c for persons with diagnosed diabetes

    Measured: 24 months post quit date

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

    Measurement of creatinine

    Measured: 6 months post quit date

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

    Measurement of creatinine

    Measured: 12 months post quit date

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

    Measurement of creatinine

    Measured: 24 months post quit date

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

    Measurement of waist circumference

    Measured: 6 months post quit date

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

    Measurement of waist circumference

    Measured: 12 months post quit date

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

    Measurement of waist circumference

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 24 months post quit date

Secondary outcomes (12)

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

    Measurement of blood pressure

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

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

    Measurement of heart rate

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

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

    Measurement of total cholesterol

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

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

    Measurement of LDL-cholesterol

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

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

    Measurement of HDL- cholesterol

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

  6. Changes in cardiovascular disease risk factors (triglycerides)

    Measurement of triglycerides

    Measured: 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

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

  8. Changes in cardiovascular disease risk factors (creatinine)

    Measurement of creatinine

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

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

    Measurement of waist circumference

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: Change from Baseline to 6,12, 24 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 posted2 Aug 2018
  2. Study start16 Jul 2018
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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
NCT03612336
Sponsor's protocol ID
2017-02332b
Other IDs
2017
Acronym
ESTxENDS
Status last verified
Nov 2023
First submitted
25 Jun 2018
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    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

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 and Cardiovascular Diseases, 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 15 Nov 2023. 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?

Measurements of risk factors for cardiovascular diseases (blood pressure)_1 (time frame: 6 months post quit date). The study lists 30 primary outcomes in all. 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 NCT03612336, which also lists 10 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 15 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in