NCT03612544: ESTxENDS

The ESTxENDS Trial- Substudy on the Effect on Toxins From Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)

Completed NA Last updated 15 November 2023

What this trial tests

NA trial testing ENDS (Vaporizer/e-cig) and smoking cessation counseling in Smoking Cessation in 1,246 participants. Completed in 31 August 2023.

Timeline

16 July 2018

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	University of Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,246
Start date	16 July 2018
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	5 locations across Switzerland

Drugs / interventions tested

• ENDS (Vaporizer/e-cig) and smoking cessation counseling
• Smoking cessation counseling

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Toxicity — all drugs for Toxicity →

Sponsor

University of Bern

Who can join

18 and older, any sex, with Smoking Cessation or Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

--\> 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.

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2020 · cited 314× · PMID 33052602 · DOI 10.1002/14651858.cd010216.pub4
2. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, Lindson N, Butler AR, McRobbie H, et al · · 2022 · cited 147× · PMID 36384212 · DOI 10.1002/14651858.cd010216.pub7
3. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2021 · cited 126× · PMID 33913154 · DOI 10.1002/14651858.cd010216.pub5
4. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, et al · · 2021 · cited 106× · PMID 34519354 · DOI 10.1002/14651858.cd010216.pub6
5. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2024 · cited 94× · PMID 38189560 · DOI 10.1002/14651858.cd010216.pub8
6. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2025 · cited 32× · PMID 39878158 · DOI 10.1002/14651858.cd010216.pub9