Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial
Open accessAbstract
Importance: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. Objective: To evaluate e-cigarettes with individual counseling for smoking cessation. Design, Setting, and Participants: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. Interventions: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. Main Outcomes and Measures: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. Results: Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%). Conclusions and Relevance: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02417467.
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Examining interim outcome data can bias trial results and interpretation and introduce analytical and ethical challenges when interim analyses are not prespecified or lead to early study termination.
“Examining interim outcome data can bias trial results and interpretation and introduce analytical and ethical challenges when interim analyses are not prespecified or lead to early study termination.”
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- Authors
- Eisenberg, M. J., Hébert-Losier, A., Windle, S. B., Greenspoon, T., Brandys, T., Fülöp, T., Nguyen, T., Elkouri, S., Montigny, M., Wilderman, I., Bertrand, O. F., Bostwick, J. A., Abrahamson, J., Lacasse, Y., Pakhale, S., Cabaussel, J., Filion, K. B., & E3 Investigators
- Affiliations
- Jewish General Hospital (CA)
- Hamilton Community Health Centre, Family Health Organization, Hamilton, Ontario, Canada
- Ottawa Hospital (CA)
- Centre de recherche sur le vieillissement (CA)
- St. Boniface Hospital (CA)
- Centre Hospitalier de l’Université de Montréal (CA)
- Centre Integre de Sante et de Services Sociaux de Laval (CA)
- Wilderman Medical Clinic (CA)
- Institut universitaire de cardiologie et de pneumologie de Québec (CA)
- Montfort Hospital (CA)
- Toronto East General Hospital (CA)
- Ottawa Hospital Research Institute (CA)
- Corresponding author
- Eisenberg, Mark J.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-11-10
- Volume
- 324
- Issue
- 18
- Pages
- 1844
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC7656286
- OpenAlex
- W3104688367
- Cited by
- 110
- References
- 28
- Citations by year
- 2026: 7 · 2025: 21 · 2024: 21 · 2023: 13 · 2022: 20 · 2021: 27 · 2012: 1
- FWCI
- 9.01
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Prenatal Substance Exposure Effects
- Keywords
- electronic cigarettes, smoking cessation, nicotine e-cigarettes, individual counseling, nicotine replacement therapy, abstinence, expired carbon monoxide, adverse events, medication adherence, early trial termination, tobacco control, tobacco control research funding
- MeSH terms
- Smoking Reduction, Adult, Combined Modality Therapy, Counseling, Female, Humans, Male, Middle Aged, Tobacco Use Disorder, Smoking Cessation, Early Termination of Clinical Trials, Self Report, Tobacco Use Cessation Devices, Electronic Nicotine Delivery Systems
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