AzTrials
AzTrials

Smoking CessationESTxENDSNCT03612544

The ESTxENDS Trial- Substudy on the Effect on Toxins From 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 Toxicity, 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). Toxins outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland. 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, Toxicity
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 Toxins Substudy of ESTxENDS

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

Cigarette smoking is the leading cause of preventable death in Switzerland. 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.

Read more

Conventional cigarettes release toxic chemicals in tobacco smoke through thermochemical degradation and pyrolysis processes by combusting tobacco, but in ENDS toxicants can be released by heating up nicotine-containing e-liquids to produce vapor. The e-liquid in ENDS is mostly made of propylene glycol (PG) and vegetal glycerin (VG) in addition to nicotine, flavorings and sometimes alcohol as a conservation agent. The heating process of the e-liquid in ENDS, has been shown to release carcinogens such as some carbonyl and volatile organic compounds (i.e., formaldehyde, acetaldehyde and acrolein). Some devices might also release heavy metals such as cadmium, lead and mercury. The source of such metals may be the metal of the device or the e-liquids. Although unexpected from the composition of the e-liquids, some studies have also detected tobacco-specific nitrosamines (TNSAs) (N'-nitrosonornicotine (NNN) and 4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)) and polycyclic aromatic hydrocarbons (PAHs) (1- and 2-Naphtol and 1-hydroxypyrene (1-OHP)).

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), 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. All participants will be followed over a 24-month period. Chemicals such as VOCs, PAHs, TSNAs, heavy metals, nicotine and nicotine degradation products will first be quantified in the aerosol produced by ENDS in laboratory conditions. These chemicals and their metabolites will then be measured at baseline and at 6-, 12- and 24- months' follow-up in urine samples from study participants.

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 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 NCT03612544
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. Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_1

    Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

    Measured: 6 months post quit date

  2. Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_2

    Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

    Measured: 12 months post quit date

  3. Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_3

    Measurement of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) in urine

    Measured: 24 months post quit date

  4. Concentrations of urinary NNN (N-nitrosonornicotine)_1

    Measurement of NNN (N-nitrosonornicotine) in urine

    Measured: 6 months post quit date

  5. Concentrations of urinary NNN (N-nitrosonornicotine)_2

    Measurement of NNN (N-nitrosonornicotine) in urine

    Measured: 12 months post quit date

  6. Concentrations of urinary NNN (N-nitrosonornicotine)_3

    Measurement of NNN (N-nitrosonornicotine) in urine

    Measured: 24 months post quit date

  7. Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_1

    Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

    Measured: 6 months post quit date

  8. Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_2

    Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

    Measured: 12 months post quit date

  9. Concentrations of urinary NNK (nicotine-derived nitrosamine ketone)_3

    Measurement of NNK (nicotine-derived nitrosamine ketone) in urine

    Measured: 24 months post quit date

  10. Concentrations of urinary metabolites of VOCs (volatile organic compounds)_1

    Measurements of metabolites of VOCs in urine

    Measured: 6 months post quit date

  11. Concentrations of urinary metabolites of VOCs (volatile organic compounds)_2

    Measurements of metabolites of VOCs in urine

    Measured: 12 months post quit date

  12. Concentrations of urinary metabolites of VOCs (volatile organic compounds)_3

    Measurements of metabolites of VOCs in urine

    Measured: 24 months post quit date

  13. Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_1

    Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

    Measured: 6 months post quit date

  14. Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_2

    Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

    Measured: 12 months post quit date

  15. Concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)_3

    Measurement of PAHs (Polycyclic aromatic hydrocarbons) in urine

    Measured: 24 months post quit date

  16. Concentrations of urinary heavy metals_1

    Measurement of heavy metals in urine

    Measured: 6 months post quit date

  17. Concentrations of urinary heavy metals_2

    Measurement of heavy metals in urine

    Measured: 12 months post quit date

  18. Concentrations of urinary heavy metals_3

    Measurement of heavy metals in urine

    Measured: 24 months post quit date

  19. Concentrations of urinary nicotine metabolites_1

    Measurement of nicotine metabolites in urine

    Measured: 6 months post quit date

  20. Concentrations of urinary nicotine metabolites_2

    Measurement of nicotine metabolites in urine

    Measured: 12 months post quit date

  21. Concentrations of urinary nicotine metabolites_3

    Measurement of nicotine metabolites in urine

    Measured: 24 months post quit date

Secondary outcomes (7)

  1. Change in concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)

    Change of NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  2. Change in concentrations of urinary NNN (N-nitrosonornicotine)

    Change of NNN (N-nitrosonornicotine) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  3. Change in concentrations of urinary NNK (nicotine-derived nitrosamine ketone)

    Change of NNK (nicotine-derived nitrosamine ketone) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  4. Change in concentrations of urinary VOCs (volatile organic compounds)

    Change of VOCs (volatile organic compounds) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  5. Change in concentrations of urinary PAHs (Polycyclic aromatic hydrocarbons)

    Change of PAHs (Polycyclic aromatic hydrocarbons) concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  6. Change in concentrations of urinary heavy metals

    Change of heavy metals concentrations in urine from baseline to 6, 12, and 24 months post quit date.

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

  7. Change in concentrations of urinary nicotine metabolites

    Change of nicotine metabolites concentrations in urine from baseline to 6, 12, and 24 months post quit date.

    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
NCT03612544
Sponsor's protocol ID
2017-02332e
Other IDs
2017
Acronym
ESTxENDS
Status last verified
Nov 2023
First submitted
2 Jul 2018
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • Orr MS. Electronic cigarettes in the USA: a summary of available toxicology data and suggestions for the future. Tob Control. 2014 May;23 Suppl 2(Suppl 2):ii18-22. doi: 10.1136/tobaccocontrol-2013-051474.

    PubMed 24732158

  • Bertholon JF, Becquemin MH, Roy M, Roy F, Ledur D, Annesi Maesano I, Dautzenberg B. [Comparison of the aerosol produced by electronic cigarettes with conventional cigarettes and the shisha]. Rev Mal Respir. 2013 Nov;30(9):752-7. doi: 10.1016/j.rmr.2013.03.003. Epub 2013 Apr 17. French.

    PubMed 24267765

  • Etter JF, Bullen C. Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction. 2011 Nov;106(11):2017-28. doi: 10.1111/j.1360-0443.2011.03505.x. Epub 2011 Jul 27.

    PubMed 21592253

  • Etter JF, Zather E, Svensson S. Analysis of refill liquids for electronic cigarettes. Addiction. 2013 Sep;108(9):1671-9. doi: 10.1111/add.12235. Epub 2013 May 23.

    PubMed 23701634

  • Flouris AD, Poulianiti KP, Chorti MS, Jamurtas AZ, Kouretas D, Owolabi EO, Tzatzarakis MN, Tsatsakis AM, Koutedakis Y. Acute effects of electronic and tobacco cigarette smoking on complete blood count. Food Chem Toxicol. 2012 Oct;50(10):3600-3. doi: 10.1016/j.fct.2012.07.025. Epub 2012 Jul 31.

    PubMed 22858449

  • Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob P 3rd, Benowitz N. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014 Mar;23(2):133-9. doi: 10.1136/tobaccocontrol-2012-050859. Epub 2013 Mar 6.

    PubMed 23467656

  • Ingebrethsen BJ, Cole SK, Alderman SL. Electronic cigarette aerosol particle size distribution measurements. Inhal Toxicol. 2012 Dec;24(14):976-84. doi: 10.3109/08958378.2012.744781.

    PubMed 23216158

  • McAuley TR, Hopke PK, Zhao J, Babaian S. Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality. Inhal Toxicol. 2012 Oct;24(12):850-7. doi: 10.3109/08958378.2012.724728.

    PubMed 23033998

  • Pellegrino RM, Tinghino B, Mangiaracina G, Marani A, Vitali M, Protano C, Osborn JF, Cattaruzza MS. Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM). Ann Ig. 2012 Jul-Aug;24(4):279-88.

    PubMed 22913171

  • Uchiyama S, Ohta K, Inaba Y, Kunugita N. Determination of carbonyl compounds generated from the E-cigarette using coupled silica cartridges impregnated with hydroquinone and 2,4-dinitrophenylhydrazine, followed by high-performance liquid chromatography. Anal Sci. 2013;29(12):1219-22. doi: 10.2116/analsci.29.1219.

    PubMed 24334991

  • Walton KM, Abrams DB, Bailey WC, Clark D, Connolly GN, Djordjevic MV, Eissenberg TE, Fiore MC, Goniewicz ML, Haverkos L, Hecht SS, Henningfield JE, Hughes JR, Oncken CA, Postow L, Rose JE, Wanke KL, Yang L, Hatsukami DK. NIH electronic cigarette workshop: developing a research agenda. Nicotine Tob Res. 2015 Feb;17(2):259-69. doi: 10.1093/ntr/ntu214. Epub 2014 Oct 21.

    PubMed 25335949

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 Toxicity, 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?

Concentrations of urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol)_1 (time frame: 6 months post quit date). The study lists 21 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 NCT03612544, which also lists 12 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