Randomized Trial of E-Cigarettes vs. Nicotine-Replacement Therapy - E-Cigarettes vs. Nicotine-Replacement Therapy

Contribution To Literature:

This trial demonstrated that e-cigarettes are more efficacious compared with nicotine-replacement products for abstinence at 1 year among participants motivated to quit smoking, although the overall success rate remains very low.


The goal of the trial was to assess the efficacy of refillable e-cigarettes as compared with nicotine replacement among adults seeking help to quit smoking.

Study Design

Adults seeking help for smoking cessation were randomized in a 1:1 fashion to either e-cigarettes (n = 438) or a nicotine-replacement product (n = 446). All participants in the e-cigarette group received a starter pack, called One Kit, to facilitate initial use and teach participants how to use refillable e-cigarette products, along with one bottle of e-liquid, containing nicotine at a concentration of 18 mg/ml. Participants were asked to purchase their future e-liquid online or from local vape shops and to buy a different e-cigarette device if the one supplied did not meet their needs. In the nicotine-replacement group, participants were informed about the range of nicotine-replacement products (patch, gum, lozenges, nasal spray, inhalator, mouth spray, mouth strip, and microtabs) and selected their preferred product. All the participants received the same multisession behavioral support as per UK stop-smoking service practice (weekly one-on-one sessions with local clinicians, who also monitored expired carbon monoxide levels for at least 4 weeks after the quit date).

  • Total screened: 2,045
  • Total number of enrollees: 884
  • Duration of follow-up: 1 year
  • Median patient age: 41 years
  • Percentage female: 48%

Inclusion criteria:

  • Age >18 years
  • No strong preference to use or not to use nicotine replacement or e-cigarettes
  • Currently not using either type of product
  • Agreeable to signing a commitment to not use the nonassigned treatment for at least 4 weeks after their quit date

Other salient features/characteristics:

  • Past use of nicotine replacement: 75%; past use of e-cigarettes: 42%

Principal Findings:

The primary outcome, abstinence at 52 weeks, for e-cigarettes vs. nicotine replacement, was 18% vs. 9.9%, relative risk 1.83, 95% confidence interval 1.30-2.58, p < 0.001.

Secondary outcomes, for e-cigarettes vs. nicotine replacement:

  • Among participants with 1-year abstinence, use of assigned product at 52 weeks: 80% vs. 9%, p < 0.05
  • Abstinence at 4 weeks: 43.8% vs. 30.0%; at 26 weeks: 35.4% vs. 25.1%, both p < 0.05
  • Composite urge (to smoke) score at 4 weeks: 2.0 vs. 2.3, p < 0.05
  • Cough at 52 weeks: 30.8% vs. 39.8%, p < 0.05


The results of this trial indicate that e-cigarettes are more efficacious compared with nicotine-replacement products for abstinence at 1 year among participants motivated to quit smoking, although overall success rate remains very low (<1 in 5 for e-cigarettes, and <1 in 10 for nicotine-replacement). Nearly half of the participants quit smoking cessation efforts within the first month itself. Participants in the e-cigarette group had less urge (frequency and strength) to smoke again. Respiratory symptoms including cough and phlegm formation were lower in the e-cigarette group as well.

These are interesting results and highlight the difficulty in smoking cessation efforts. The effect of e-cigarettes on clinical outcomes is under active investigation, with recent studies suggesting a higher risk of cardiovascular events. It is thus unclear if this strategy should be endorsed for smoking cessation in clinical practice, and if so, in which participants.


Hajek P, Phillips-Waller A, Przulj D, et al. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med 2019;380:629-37.

Editorial: Drazen JM, Morrissey S, Campion EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019;380:679-80.

Editorial: Borrelli B, O’Connor GT. E-Cigarettes to Assist With Smoking Cessation. N Engl J Med 2019;380:678-9.

Keywords: Carbon Monoxide, Nasal Sprays, Nebulizers and Vaporizers, Nicotine, Primary Prevention, Risk, Smoking, Smoking Cessation, Tobacco Products, Tobacco Use Cessation Devices

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