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E-Cigarettes vs. pills: which helps smokers quit best?

NCT ID NCT03630614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

Cigarette Smoking Smoking Cessation Vaping

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Groupe Hospitalier Pitié-Salpétrière

    Paris, 75013, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.