ESTxENDS Trial: MN Substudy - Micronuclei in Buccal Epithelium, a Surrogate Measure of Future Cancer Risk, Induced by Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig)

NACompletedINTERVENTIONAL
Enrollment

1,246

Participants

Timeline

Start Date

November 18, 2019

Primary Completion Date

August 31, 2023

Study Completion Date

August 31, 2023

Conditions
Smoking CessationMicronuclei
Interventions
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.

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.

Trial Locations (5)

1011

Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne, Lausanne

1211

Département de médecine interne, Hôpitaux universitaires de Genève, Geneva

3010

University Clinic for General Internal Medicine, Bern University Hospital, Bern

Unknown

Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen, Sankt Gallen

Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich

All Listed Sponsors
collaborator

University of Lausanne

OTHER

collaborator

University of Geneva, Switzerland

OTHER

collaborator

University of Zurich

OTHER

collaborator

State Hospital, St. Gallen

OTHER_GOV

collaborator

Swiss National Science Foundation

OTHER

collaborator

Krebsforschung Schweiz, Bern, Switzerland

OTHER

collaborator

Federal Office of Public Health, Switzerland

OTHER_GOV

lead

University of Bern

OTHER

NCT04244773 - ESTxENDS Trial: MN Substudy - Micronuclei in Buccal Epithelium, a Surrogate Measure of Future Cancer Risk, Induced by Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) | Biotech Hunter | Biotech Hunter