Electronic Nicotine Delivery Systems for Smoking Cessation

Background: Electronic nicotine delivery systems (ENDS) are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of ENDS use for tobacco smoking cessation are needed. Methods: In this open-label, controlled trial, we randomized adult smokers of at least 5 tobacco cigarettes/day and willing to set a quit date to an intervention involving provision of free ENDS and e-liquids in addition to standard-of-care smoking cessation counseling (SOC) including the optional use of nicotine replacement therapy (NRT), or to control. The control group received SOC and a voucher for the optional purchase of NRT. The primary outcome was biochemically validated, continuous self-reported tobacco cigarette smoking abstinence 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: We randomized 1246 participants. Validated continuous abstinence rate from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (RR:1.77;95% confidence interval: 1.43 to 2.20). Abstinence from tobacco smoking in the 7 days prior to the 6-months visit was 59.6% in the intervention group vs 38.5% in the control group, but abstinence from nicotine use (through tobacco smoking, ENDS or NRT use) was 20.1% in the intervention group and 33.7% in the control group. SAEs occurred in 25 (4%) and 31 (5%) of the intervention and control group participants, respectively; AEs in 272 (43.7%) and 229 (36.7%). Conclusion: The addition of ENDS to SOC counseling increased abstinence from tobacco among smokers more than SOC alone. Trial Registration: ClinicalTrials NCT03589989. Funding source: Swiss National Science Foundation, Swiss Tobacco Prevention Fund, Swiss Cancer Research and LungeZürich

Reto Auer, Anna Schoeni, Jean-Paul Humair, Isabelle Jacot-Sadowski, Ivan Berlin, Mirah J. Stuber, Moa Lina Haller, Rodrigo Casagrande Tango, Anja Frei, Alexandra Strassmann, Philip Bruggmann, Florent Baty, Martin Brutsche, Kali Tal, Stéphanie Baggio, Julian Jakob, Nicolas Sambiagio, Nancy B. Hopf, Martin Feller, Nicolas Rodondi, Aurélie Berthet