ESTxENDS Trial-Substudy on Oxidative Stress Induced by Electronic Nicotine Delivery Systems (ENDS) Measured in Urine (ESTxENDS)

November 13, 2023 updated by: University of Bern

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

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Oxidative stress 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 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.

Smoking induces inflammation leading to acute and chronic oxidative stress, both evidenced in in vitro and in vivo studies. Tobacco-smoke contains free reactive radicals that generate reactive oxygen species (ROS). Afterwards ROS in turn induce oxidative stress, which likely plays a key role in causing airways and related pathologies linked to tobacco-smoke exposure. Acute and chronic oxidative stress can be measured by quantifying two biomarkers in urine samples: 8-iso-prostaglandin F2α (8-isoprostane) and 8-Oxo-2'-deoxyguanosine (8-OHdG). 8-isoprostane, a marker of lipoperoxidation, results mainly from the non-enzymatic action of free radical attack on arachidonic fatty acids. 8-OHdG is a marker of DNA oxidation caused by ROS, and a predictor of lung cancer.

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 the setting of a randomized controlled trial (RCT). This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events, the exposure to inhaled chemicals and the effect of ENDS on health-related outcomes, in particular by measuring oxidative stress in urine samples.

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. Measures of oxidative stress by means of exhaled breath condensates and urine samples will be assessed at baseline and at 6-, 12- and 24- months' follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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 study
  • Persons having used ENDS regularly in the 3 months preceding the baseline visit
  • Persons having used nicotine replacement therapy (NRT) or other drug therapy helping smokers quit (varenicline, bupropion) within the 3 months preceding the baseline visit
  • Plans to move out of the country within the next 6 months, or 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Other: ENDS (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.
Active Comparator: Control group
Other: smoking 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary 8-OHdG concentrations to asses oxidative stress_1
Time Frame: 6 months post quit date
Oxidative stress assessed by 8-OHdG concentrations in urine.
6 months post quit date
Urinary 8-OHdG concentrations to asses oxidative stress_2
Time Frame: 12 months post quit date
Oxidative stress assessed by 8-OHdG concentrations in urine.
12 months post quit date
Urinary 8-OHdG concentrations to asses oxidative stress_3
Time Frame: 24 months post quit date
Oxidative stress assessed by 8-OHdG concentrations in urine.
24 months post quit date
Urinary 8-isoprostane concentrations to asses oxidative stress_1
Time Frame: 6 months post quit date
Oxidative stress assessed by 8-isoprostane concentrations in urine.
6 months post quit date
Urinary 8-isoprostane concentrations to asses oxidative stress_2
Time Frame: 12 months post quit date
Oxidative stress assessed by 8-isoprostane concentrations in urine.
12 months post quit date
Urinary 8-isoprostane concentrations to asses oxidative stress_3
Time Frame: 24 months post quit date
Oxidative stress assessed by 8-isoprostane concentrations in urine.
24 months post quit date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary 8-OHdG concentrations to asses oxidative stress
Time Frame: Change from baseline to 6,12, 24 months post quit date
Oxidative stress assessed by 8-OHdG concentrations in urine.
Change from baseline to 6,12, 24 months post quit date
Change in urinary 8-isoprostane concentrations to asses oxidative stress
Time Frame: Change from baseline to 6,12, 24 months post quit date
Oxidative stress assessed by 8-isoprostane concentrations in urine.
Change from baseline to 6,12, 24 months post quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

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

Investigators

  • Study Director: Reto Auer, Prof.Dr.med, Berner Institut für Hausarztmedizin; Universität Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-02332c

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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