Smoking CessationPhase 3ECSMOKENCT03630614
Randomized Trial of Electronic Cigarettes With or Without Nicotine in Smoking Cessation.
A Phase 3 study testing Electronic cigarette without nicotine (ECwN) plus active varenicline tablets in people with Smoking Cessation and Smoking, Cigarette, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette, Electronic Cigarette
- What is being tested?
- Electronic cigarette without nicotine (ECwN) plus active varenicline tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2018to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
- Aged 18 to 70 years
- Motivated to quit defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
- Signed written informed consent
- Understanding and speaking French
- 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
- Individual affiliated to a health insurance system as defined by the sponsor (except Aide Médicale d'État =AME)
- Previous failure of nicotine replacement therapy for smoking cessation
Who cannot join
- 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)
- any life threatening condition with life-expectancy of less than 3 months
- alcohol use disorder defined as a score ≥ 10 on the AUDIT-C questionnaire
- abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
- regular use of tobacco products other than cigarettes
- current or previous (last 6 months) use of electronic cigarette
Show all 14Show fewer
- pregnant women
- breastfeeding women
- protected adults
- current or past 3 months participation in another interventional research
- current or past (last 3 months) use of smoking cessation medication such as varenicline, bupropion, nicotine replacement therapies
- known lactose intolerance (placebo tablets contain lactose)
- hypersensitivity to the active substance or to any of the excipients
- known severe renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Background:
Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.
Read more
One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.
Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.
The clinical study's hypothesis:
EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.
Read the detailed description
This is a randomized, placebo controlled, multicenter, double dummy, parallel groups, phase III type pivotal trial.
Included participants are randomly assigned to one of the 3 groups:
- Control group: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline: placebo condition B) Experimental group: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition C) Reference group: ECwoN plus varenicline tablets: varenicline condition Ratio: A:B:C= 1:3:3 Each participant uses an EC and 2x2 tablets per day. Group allocation is stratified by age at cut off of 45 years.
Enrolment is initiated by two ways:
- Potential participants aware of the study register at the study's recruitment website; call in or send an email followed by a phone screen. The screening starts with the participant's information about the study's aims, constraints, benefits and risks. A maximum one week delay of reflection is allowed if the potential participant is asking for a delay to sign his/her consent form.
After screening, an appointment for the inclusion visit is provided at the closest investigation center.
- Referred or self-referred potential participants consulting for smoking cessation are proposed an inclusion visit.
The participant is informed that in this study, the smoking cessation shall occur within 15 days following the signature of the written consent.
Baseline visit = inclusion visit = V0 The Inclusion visit can immediately follow the screening visit if the participant does not need time for reflection.
The investigator checks the inclusion and exclusion criteria and if the participant is conform to them, the investigator collects informed written consent from the participant and he/she is included in the trial. The randomization can immediately follow the inclusion.
A target quit date (TQD) is defined together with the participant. The TQD defines the date when the randomized participant stops smoking. This is the starting date of the post-quit period. Start of treatment should occur within 7 days after the randomization visit.
All treatments are launched one week before the TQD. During this period smoking conventional cigarettes is allowed.
Follow-up visits : Visit 1 to Visit 6 Target quit date (TQD) should occur between 7 and 15 days after randomization. The first post-quit date visit (Visit 1)is at Week 2 after TQD i.e. 3 weeks after treatment initiation = Day 21 after treatment initiation.
Visit 2 is at Week 4 after TQD i.e. 5 weeks after treatment initiation = Day 35 after treatment initiation.
Visit 3 is at Week 8 after TQD i.e. 9 weeks after treatment initiation = Day 63 after treatment initiation.
Visit 4 is at Week 10 after TQD i.e. 11 weeks after treatment initiation = Day 77 after treatment initiation.
Visit 5 is at Week 12 after TQD i.e. 13 weeks after treatment initiation = Day 91 after treatment initiation.
Visit 6 is at Week 24 after TQD i.e. 25 weeks after treatment initiation = Day 175 after treatment initiation.
The visits should be realized +/- 5 days with respect to the planned date of the visits.
End of study visit The end of research visit is the Visit 6, at week 24 after TQD. This visit is identical to the previous follow up visits.
- Conditions
- Smoking Cessation, Smoking, Cigarette, Electronic Cigarette
- Being tested
- Electronic cigarette without nicotine (ECwN) plus active varenicline tablets, Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline, Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline
- Keywords
- smokers, electronic cigarette, nicotine, varenicline, randomized, double blind, double dummy
- Medical subject headings
- Smoking Cessation, Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigarette without nicotine (ECwN) plus active varenicline tabletsDrug
Also called Vareniclin condition
The ECwN group use EC liquids containing 0 mg/mL of nicotine. Because nicotine delivery can be adjusted according to the user's need, all participants are able to adjust their individual nicotine dose by varying the wattage of their EC, by varying puff frequency and puff volume similarly as they are doing (or used to do) with conventional cigarettes.
EC device:
Mini iStick kit (20 W) Eleaf Clearomiser :GS Air M with resistance of 1.5 ohm, the clearomiser's Pyrex window is of blue colour not allowing to distinguish an eventual coloration of the e-liquid containing nicotine. Liquids for EC use are delivered in white opaque 10 mL vials not allowing to distinguish the color of the liquid.
Varenicline, Champix® 0.50 mg tablets Posology of vareniclin follows varenicline's monograph.
Electronic cigarette without nicotine (ECwoN) plus placebo tablets of vareniclineDrug
Also called Placebo condition
The ECwoN group receives EC liquids with 0 mg/mL of nicotine on a double blind manner (in identical non-transparent refill bottles of 10 mL).
Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph.
Electronic cigarette with nicotine (ECwN) plus placebo tablets of vareniclineDrug
Also called Electronic cigarette condition
The ECwN group use EC liquids containing 12 mg/mL of nicotine. Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph.
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarette condition | Experimental | Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline Receives: Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline |
| Varenicline condition | Active comparator | Reference group: Electronic cigarette without nicotine (ECwoN) plus active varenicline tablets Receives: Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets |
| Placebo condition | Placebo comparator | Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline Receives: Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous smoking abstinence rate
Abstinence from conventional/combustible cigarettes during the last 4 weeks (weeks 9 to 12) of the treatment period of 3 months defined at Visit 4 AND Visit 5 as self-report of no smoking during the previous 2 weeks confirmed by expired air CO ≤ 8 ppm.
Measured: Weeks 9 to 12
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
The safety profile of electronic cigarette with nicotine comparatively to electronic cigarettes without nicotine and varenicline
Measured: From randomisation up to end of study (Week 24 after target quit date).
Point prevalence abstinence rate: 7-day smoking abstinence at each visit.
Measured: From randomisation up to end of study (Week 24 after target quit date).
Time to relapse to smoking after the predefined quit day.
Measured: From randomisation up to end of study (Week 24 after target quit date).
Change in cigarettes/day consumption
Measured: From randomisation up to end of study (Week 24 after target quit date).
French Tobacco Craving Questionnaire of 12 items (FTCQ-12)
Change in craving for tobacco
Measured: From randomisation up to end of study (Week 24 after target quit date).
Minnesota Nicotine Withdrawal Scale
Change in tobacco withdrawal symptoms
Measured: From randomisation up to end of study (Week 24 after target quit date).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start17 Oct 2018
- Primary completionFeb 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo and reference treatment controlled, multicenter, double blind, double dummy, parallel group, pivotal, phase III trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630614
- Sponsor's protocol ID
- P150952J
- Other IDs
- 2017-003588-37, 2017
- Acronym
- ECSMOKE
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berlin I, Dautzenberg B, Lehmann B, Palmyre J, Liegey E, De Rycke Y, Tubach F. Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. BMJ Open. 2019 May 24;9(5):e028832. doi: 10.1136/bmjopen-2018-028832.
PubMed 31129603
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
- ClinicalTrials.gov ID
- NCT03630614
- Acronym / sponsor ID
- ECSMOKE / P150952J
- Conditions
- Smoking Cessation, Smoking, Cigarette, Electronic Cigarette
- Keywords
- smokers, electronic cigarette, nicotine, varenicline, randomized, double blind, double dummy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.
One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.
Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.
The clinical study's hypothesis:
EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.
Detailed description
This is a randomized, placebo controlled, multicenter, double dummy, parallel groups, phase III type pivotal trial.
Included participants are randomly assigned to one of the 3 groups:
- Control group: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline: placebo condition B) Experimental group: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition C) Reference group: ECwoN plus varenicline tablets: varenicline condition Ratio: A:B:C= 1:3:3 Each participant uses an EC and 2x2 tablets per day. Group allocation is stratified by age at cut off of 45 years.
Enrolment is initiated by two ways:
- Potential participants aware of the study register at the study's recruitment website; call in or send an email followed by a phone screen. The screening starts with the participant's information about the study's aims, constraints, benefits and risks. A maximum one week delay of reflection is allowed if the potential participant is asking for a delay to sign his/her consent form.
After screening, an appointment for the inclusion visit is provided at the closest investigation center.
- Referred or self-referred potential participants consulting for smoking cessation are proposed an inclusion visit.
The participant is informed that in this study, the smoking cessation shall occur within 15 days following the signature of the written consent.
Baseline visit = inclusion visit = V0 The Inclusion visit can immediately follow the screening visit if the participant does not need time for reflection.
The investigator checks the inclusion and exclusion criteria and if the participant is conform to them, the investigator collects informed written consent from the participant and he/she is included in the trial. The randomization can immediately follow the inclusion.
A target quit date (TQD) is defined together with the participant. The TQD defines the date when the randomized participant stops smoking. This is the starting date of the post-quit period. Start of treatment should occur within 7 days after the randomization visit.
All treatments are launched one week before the TQD. During this period smoking conventional cigarettes is allowed.
Follow-up visits : Visit 1 to Visit 6 Target quit date (TQD) should occur between 7 and 15 days after randomization. The first post-quit date visit (Visit 1)is at Week 2 after TQD i.e. 3 weeks after treatment initiation = Day 21 after treatment initiation.
Visit 2 is at Week 4 after TQD i.e. 5 weeks after treatment initiation = Day 35 after treatment initiation.
Visit 3 is at Week 8 after TQD i.e. 9 weeks after treatment initiation = Day 63 after treatment initiation.
Visit 4 is at Week 10 after TQD i.e. 11 weeks after treatment initiation = Day 77 after treatment initiation.
Visit 5 is at Week 12 after TQD i.e. 13 weeks after treatment initiation = Day 91 after treatment initiation.
Visit 6 is at Week 24 after TQD i.e. 25 weeks after treatment initiation = Day 175 after treatment initiation.
The visits should be realized +/- 5 days with respect to the planned date of the visits.
End of study visit The end of research visit is the Visit 6, at week 24 after TQD. This visit is identical to the previous follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, placebo and reference treatment controlled, multicenter, double blind, double dummy, parallel group, pivotal, phase III trial.
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarette condition | Experimental | Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of vareniclineElectronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline |
| Varenicline condition | Active comparator | Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tabletsReference group: Electronic cigarette without nicotine (ECwoN) plus active varenicline tablets |
| Placebo condition | Placebo comparator | Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of vareniclineElectronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
- Aged 18 to 70 years
- Motivated to quit defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
- Signed written informed consent
- Understanding and speaking French
Key exclusion criteria (14 listed)
- 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)
- any life threatening condition with life-expectancy of less than 3 months
- alcohol use disorder defined as a score ≥ 10 on the AUDIT-C questionnaire
- abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
- regular use of tobacco products other than cigarettes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic cigarette without nicotine (ECwN) plus active varenicline tabletsAlso: Vareniclin conditionThe ECwN group use EC liquids containing 0 mg/mL of nicotine. Because nicotine delivery can be adjusted according to the user's need, all participants are able to adjust their individual nicotine dose by varying the wattage of their EC, by varying puff frequency and puff volume similarly as they are doing (or used to do) with conventional cigarettes. EC device: Mini iStick kit (20 W) Eleaf Clearomiser :GS Air M with resistance of 1.5 ohm, the clearomiser's Pyrex window is of blue colour not allowing to distinguish an eventual coloration of the e-liquid containing nicotine. Liquids for EC use are delivered in white opaque 10 mL vials not allowing to distinguish the color of the liquid. Varenicline, Champix® 0.50 mg tablets Posology of vareniclin follows varenicline's monograph. | Drug | Varenicline condition |
| Electronic cigarette without nicotine (ECwoN) plus placebo tablets of vareniclineAlso: Placebo conditionThe ECwoN group receives EC liquids with 0 mg/mL of nicotine on a double blind manner (in identical non-transparent refill bottles of 10 mL). Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph. | Drug | Placebo condition |
| Electronic cigarette with nicotine (ECwN) plus placebo tablets of vareniclineAlso: Electronic cigarette conditionThe ECwN group use EC liquids containing 12 mg/mL of nicotine. Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph. | Drug | Electronic cigarette condition |
Primary outcome
Continuous smoking abstinence rate
Time frame: Weeks 9 to 12
Abstinence from conventional/combustible cigarettes during the last 4 weeks (weeks 9 to 12) of the treatment period of 3 months defined at Visit 4 AND Visit 5 as self-report of no smoking during the previous 2 weeks confirmed by expired air CO ≤ 8 ppm.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: From randomisation up to end of study (Week 24 after target quit date).
Point prevalence abstinence rate: 7-day smoking abstinence at each visit.
Time frame: From randomisation up to end of study (Week 24 after target quit date).
Time to relapse to smoking after the predefined quit day.
Time frame: From randomisation up to end of study (Week 24 after target quit date).
Change in cigarettes/day consumption
Time frame: From randomisation up to end of study (Week 24 after target quit date).
French Tobacco Craving Questionnaire of 12 items (FTCQ-12)
Time frame: From randomisation up to end of study (Week 24 after target quit date).
Minnesota Nicotine Withdrawal Scale
Time frame: From randomisation up to end of study (Week 24 after target quit date).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 31129603Berlin I, Dautzenberg B, Lehmann B, Palmyre J, Liegey E, De Rycke Y, Tubach F. Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. BMJ Open. 2019 May 24;9(5):e028832. doi: 10.1136/bmjopen-2018-028832.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic cigarette without nicotine (ECwN) plus active varenicline tablets in people with Smoking Cessation and Smoking, Cigarette, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous smoking abstinence rate (time frame: Weeks 9 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.