E-Cigarettes for Smoking Cessation: E3 Trial Summary

A randomized controlled trial led by Dr. Mark J. Eisenberg at McGill University evaluated the efficacy and safety of E-Cigarettes (ECs) for smoking cessation. The study aimed to compare the effectiveness of nicotine and non-nicotine ECs with individual counseling against counseling alone. The trial focused on assessing primary outcomes like abstinence rates and safety measures such as side effects. Despite challenges with sample size calculations, the study concluded with valuable insights into the use of ECs as a smoking cessation aid.

• Smoking Cessation
• E-Cigarettes
• Randomized Controlled Trial
• McGill University
• Health Research

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1. A Randomized Controlled Trial Evaluating the Efficacy and Safety of E-Cigarettes for Smoking Cessation Mark J. Eisenberg, MD MPH Professor of Medicine McGill University for the E3 Investigators

2. Disclosures Dr. Wilderman received financial compensation from Pfizer Inc. for his involvement in a smoking cessation study using varenicline. The other authors have no conflicts of interest to declare.

3. E3 Trial Background The long-term health effects of inhaling combustible tobacco are well established. Even with use of pharmacologic or behavioral therapy, > 2/3 of those attempting to quit return to smoking within 1 year. Many smokers have adopted the use of e-cigarettes (ECs) to quit. The efficacy and safety of ECs for smoking cessation remain poorly delineated.

4. E3 Trial Objective To examine the efficacy and safety of nicotine and non-nicotine ECs with individual counseling compared to counseling alone.

5. E3 Trial Design Treatment Period (12 Weeks) Active Smokers ( 10 Cigarettes/Day) Nicotine ECs & Counseling Follow-Up (Weeks) Informed Consent & Eligibility Assessment Smokers (17 centers) Non-Nicotine ECs & Counseling Tel 1, 2, 8, & 18 Clinic 4, 12, 24, & 52 Motivated to Quit Counseling Hebert-Losier A et al. Can J Cardiol Open https://doi.org/10.1016/j.cjco.2020.03.006

6. E3 Trial Endpoints Primary Point prevalence abstinence (12 weeks) Self-reported abstinence in past week and exhaled CO 10 ppm Safety Side effects, AEs, and SAEs SAEs adjudicated by an Endpoints Evaluation Committee External DSMB Secondary Reduction in cigarettes/day Continuous abstinence Point prevalence abstinence

7. E3 Trial Sample Size and Power Calculations Planned: 486 10% point prevalence abstinence at 52 weeks in counseling alone Two-tailed of 0.05 > 80% power to detect 12% difference in abstinence Nicotine ECs with individual counseling vs counseling alone Enrolled: 376 (77%) Unexpected and prolonged delay in ECs manufacturing early termination < 68% power to detect 12% difference in abstinence at 52 weeks Given reduction in power, timing of primary endpoint changed to 12 weeks

8. E3 Trial Participant Flow Withdrew or Lost to Follow-Up Week 12 Status 128 128 Intention to Treat 100 Self-Reported & CO, 13 Self-Reported, 5 Vital Status Nicotine ECs & Counseling 10 127 127 Intention to Treat 91 Self-Reported & CO, 13 Self-Reported, 9 Vital Status 376 Non-Nicotine ECs & Counseling 14 Smokers 121 Intention to Treat 65 Self-Reported & CO, 17 Self-Reported, 10 Vital Status 121 29 Counseling Alone

9. E3 Trial Baseline Characteristics Prior Quit Aids (%) Years Smoked (Mean) Cigs/ Day (Mean) Tried to Quit (%) Tried an EC (%) Heart Disease (%) Resp Disease (%) Age (Mean) Male (%) Nicotine ECs & Counseling 53 49 35 21 91 79 43 17 25 Non-Nicotine ECs & Counseling 52 56 35 21 93 79 38 17 32 Counseling 53 53 35 21 89 82 27 19 28 Total 52 53 35 21 91 80 36 18 28

10. E3 Trial Point Prevalence Abstinence 30 25 20 % 15 10 5 0 Week 1 Week 2 Week 4 Week 8 Week 12 Nicotine ECs & Counseling Non-Nicotine ECs & Counseling Counseling

11. E3 Trial Point Prevalence Abstinence 30 25 22 Nicotine ECs & Counseling vs Counseling Alone RD 12.8% (95% CI 4.0, 21.6) RR 2.4 (95% CI 1.3, 4.6) 20 17 % 15 9 Non-Nicotine ECs & Counseling vs Counseling Alone RD 8.2% (95% CI -0.1, 16.6) RR 1.9 (95% CI -1.0, 3.8) 10 5 0 Week 1 Week 2 Week 4 Week 8 Week 12 Nicotine ECs & Counseling Non-Nicotine ECs & Counseling Counseling

12. E3 Trial Cigarettes Smoked/Day 20 15 Cigs /Day 10 5 0 Baseline Week 1 Week 2 Week 4 Week 8 Week 12 Nicotine ECs & Counseling Non-Nicotine ECs & Counseling Counseling

13. E3 Trial Cigarettes Smoked/Day 20 Nicotine ECs & Counseling vs Counseling Alone Mean Difference -5.7 (95% CI -8.0, -3.3) 14 15 10 Cigs /Day 10 8 Non-Nicotine ECs & Counseling vs Counseling Alone Mean Difference -3.6 (95% CI -6.3, -1.0) 5 0 Baseline Week 1 Week 2 Non-Nicotine ECs & Counseling Week 4 Week 8 Week 12 Nicotine ECs & Counseling Counseling

14. E3 Trial Continuous Abstinence 14 12 10 8 % 6 4 2 0 Week 1 Week 2 Week 4 Week 8 Week 12 Nicotine ECs & Counseling Non-Nicotine ECs & Counseling Counseling

15. E3 Trial Continuous Abstinence 14 12 Nicotine ECs & Counseling vs Counseling Alone RD 3.9% (95% CI -0.1, 7.9) RR 5.7 (95% CI 0.7, 46.4) 10 8 % 6 5 Non-Nicotine ECs & Counseling vs Counseling Alone RD 2.3% (95% CI -1.1, 5.8) RR 3.8 (95% CI 0.4, 33.6) 3 4 2 1 0 Week 1 Week 2 Week 4 Week 8 Week 12 Nicotine ECs & Counseling Non-Nicotine ECs & Counseling Counseling

16. E3 Trial Serious Adverse Events (SAEs, 12 weeks) Years Smoked Cigs / Day Time to Event (Days) Age Sex Medical History Nicotine ECs & Counseling COPD Exacerbation Non-Nicotine ECs & Counseling Appendicitis Neoplastic Cecal Lesion Myocardial Infarction Chest Pain Epistaxis Counseling Critical Limb Ischemia Urinary Tract Infection 58 M 48 25 Anxiety, Depression, COPD 12 31 91 84 88 39 63 F 49 15 Angina, COPD, DLP, HTN, PCI 64 66 67 M M M 49 50 40 40 25 30 COPD, DM, DLP, HTN DM, DLP, HTN, MI, PCI Angina, DM, DLP, PCI, Prostate CA 60 60 M M 50 48 30 40 DM, DLP HTN 43 16

17. E3 Trial Conclusions Nicotine ECs with individual counseling for 12 weeks is efficacious for smoking cessation compared to counseling alone. Non-nicotine ECs with individual counseling has benefits between those of nicotine ECs with counseling and counseling alone. Few SAEs occurred. However, there remains a need for additional safety data. Longer-term follow-up data from the E3 Trial will determine if benefits persist over time.

18. E3 Trial Team Trial Coordinators Steering Committee Mark J. Eisenberg (Chair),MD MPH Jewish General Hospital/McGill University, Montreal, QC Kristian Filion, PhD Jewish General Hospital/McGill University, Montreal, QC Andr a H bert-Losier, MSc Jewish General Hospital, Montreal, QC Sarah Windle, MPH Jewish General Hospital, Montreal, QC Site Investigators Gabor Gyenes, MD PhD, Mazankowski Alberta Heart Institute, Edmonton, AB Thao Huynh, MD, Montr al General Hospital, Montr al, QC Yves Lasse, MD, Institut de Cardiologie et de Pneumologie de Qu bec, Qu bec City, QC Martine Montigny, MD, Centre Int gr de Sant et de Services Sociaux de Laval, H pital Cit -de-la-Sant , Laval, QC Thang Nguyen, MD, St. Boniface Hospital, Winnipeg, MB Smita Pakhale,MD, The Ottawa Hospital Research Institute/The Bridge Engagement Centre, Ottawa, ON Vivek Rao, MD PhD, Toronto General Hospital, Toronto, Ontario, ON Igor Wilderman, MD, Wilderman Medical Clinic/Canadian Centre for Clinical Trials, Thornhill, ON John Abrahamson, MD, Michael Garron Hospital, Toronto, ON Gregory Baran,MD, Portsmounth Medical Clinic, Kingston, ON Olivier Bertrand,MD PhD, Institut de Cardiologie et de Pneumologie de Qu bec, Qu bec City, QC Joana Alexis Bostwick,MD, H pital Montfort, Ottawa, ON Tim Brandys, MD, Ottawa Hospital, Ottawa, ON Mark J. Eisenberg, MD MPH, Jewish General Hospital, Montr al, QC St phane Elkouri, MD, Centre Hospitalier de l Universit de Montr al, Montr al, QC Tam s F l p, MD PhD, Centre de Recherche sur le Vieillissement, Sherbrooke, QC Todd Greenspoon,MD, Hamilton Community Health Centre, Family Health Organization, Hamilton, ON Data Safety Monitoring Board Endpoints Evaluation Committee Peter Faris (Chair), PhD University of Calgary, Calgary, AB Finlay McAlister, MD University of Alberta, Edmonton, AB Andrea Gershon, MD Sunnybrook Health Sciences Centre, Toronto, ON Patrick Lawler, MD Toronto General Hospital, Toronto, ON Ali Abualsaud, MD Jewish General Hospital, Montr al, QC Ratna Samanta, MD McGill University Health Centre, Montr al, QC