NCT03612336: ESTxENDS

The ESTxENDS Trial- Substudy on the Metabolic Effects of 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 →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Bern

Who can join

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

Sponsor's own description

--\> 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.

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