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Updated: Jul 3, 2025

Comparing the Effects of Electronic Cigarette Vapor and Cigarette Smoke in a Novel In Vivo Exposure System
Published on: May 24, 2017
Electronic Nicotine-Delivery Systems for Smoking Cessation
Reto Auer1, Anna Schoeni1, Jean-Paul Humair1
1From the Institute of Primary Health Care (BIHAM) (R.A., A. Schoeni, M.J.S., M.L.H., K.T., S.B., J.J., M.F., N.R.) and the Departments of General Internal Medicine (M.J.S., N.R.) and Pediatrics (J.J.), Bern University Hospital (Inselspital), University of Bern, Bern, the University Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne (R.A., I.J.-S., I.B., N.S., N.B.H., A.B.), the Department of Primary Care Medicine, University Hospitals of Geneva, Geneva (J.-P.H., R.C.T.), the Epidemiology, Biostatistics and Prevention Institute, University of Zurich (A.F., A. Strassmann), Arud Center for Addiction Medicine (P.B.), and the Institute of Primary Care, University and University Hospital of Zurich (P.B.), Zurich, the Lung Center, Kantonsspital St. Gallen, St. Gallen (F.B., M.B.), the University of Basel, Basel (F.B., M.B.), and the Population Health Laboratory, University of Fribourg, Fribourg (S.B.) - all in Switzerland; and the Department of Medical Pharmacology, Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris (I.B.).
Background:
Electronic nicotine-delivery systems - also called e-cigarettes - are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of these systems is needed.
Methods:
In this open-label, controlled trial, we randomly assigned adults who were smoking at least five tobacco cigarettes per day and who wanted to set a quit date to an intervention group, which received free e-cigarettes and e-liquids, standard-of-care smoking-cessation counseling, and optional (not free) nicotine-replacement therapy, or to a control group, which received standard counseling and a voucher, which they could use for any purpose, including nicotine-replacement therapy. The primary outcome was biochemically validated, continuous abstinence from smoking at 6 months. Secondary outcomes included participant-reported abstinence from tobacco and from any nicotine (including smoking, e-cigarettes, and nicotine-replacement therapy) at 6 months, respiratory symptoms, and serious adverse events.
Results:
A total of 1246 participants underwent randomization; 622 participants were assigned to the intervention group, and 624 to the control group. The percentage of participants with validated continuous abstinence from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (relative risk, 1.77; 95% confidence interval, 1.43 to 2.20). The percentage of participants who abstained from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group, but the percentage who abstained from any nicotine use was 20.1% in the intervention group and 33.7% in the control group. Serious adverse events occurred in 25 participants (4.0%) in the intervention group and in 31 (5.0%) in the control group; adverse events occurred in 272 participants (43.7%) and 229 participants (36.7%), respectively.
Conclusions:
The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking-cessation counseling alone. (Funded by the Swiss National Science Foundation and others; ESTxENDS ClinicalTrials.gov number, NCT03589989.).
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