E-Cigarettes vs. pills: which helps smokers quit best?
NCT ID NCT03630614
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares nicotine e-cigarettes, nicotine-free e-cigarettes, and the medication varenicline to see which works best for helping people quit smoking. About 650 adult smokers who want to quit will take part. The main goal is to see who can stay away from regular cigarettes for the last 4 weeks of the 3-month treatment period.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 650 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2018
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year 2. Aged 18 to 70 years 3. Motivated to quit defined as a score \> 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated) 4. Signed written informed consent 5. Understanding and speaking French 6. Women of childbearing age can be included if they use an effective contraceptive method: either hormonal contraception or an intrauterine device started at least one month before the first research visit 7. Individual affiliated to a health insurance system as defined by the sponsor (except Aide Médicale d'État =AME) 8. Previous failure of nicotine replacement therapy for smoking cessation Exclusion Criteria: 1. any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments such as 1.1.recent myocardial infarction, 1.2.unstable or worsening angina 1.3.severe cardiac arrhythmia 1.4.unstable or uncontrolled arterial hypertension 1.5.recent stroke 1.6.cerebrovascular disease 1.7.obliterative peripheral arterial disease 1.8.cardiac insufficiency 1.9.diabetes 1.10.hyperthyroidism 1.11.pheochromocytoma 1.12.severe hepatic insufficiency 1.13.history of seizures 1.14.severe depression 1.15.chronic obstructive pulmonary disease (COPD) 2. any life threatening condition with life-expectancy of less than 3 months 3. alcohol use disorder defined as a score ≥ 10 on the AUDIT-C questionnaire 4. abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history 5. regular use of tobacco products other than cigarettes 6. current or previous (last 6 months) use of electronic cigarette 7. pregnant women 8. breastfeeding women 9. protected adults 10. current or past 3 months participation in another interventional research 11. current or past (last 3 months) use of smoking cessation medication such as varenicline, bupropion, nicotine replacement therapies 12. known lactose intolerance (placebo tablets contain lactose) 13. hypersensitivity to the active substance or to any of the excipients 14. known severe renal failure
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Groupe Hospitalier Pitié-Salpétrière
Paris, 75013, France
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