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Randomized Trial of Electronic Cigarettes With or Without Nicotine in Smoking Cessation. (ECSMOKE)

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ClinicalTrials.gov Identifier: NCT03630614
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Cigarette Electronic Cigarette Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo and reference treatment controlled, multicenter, double blind, double dummy, parallel group, pivotal, phase III trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
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.
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electronic cigarette condition
Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline
Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline
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.
Other Name: Electronic cigarette condition

Active Comparator: Varenicline condition
Reference group: Electronic cigarette without nicotine (ECwoN) plus active varenicline tablets
Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets

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.

Other Name: Vareniclin condition

Placebo Comparator: Placebo condition
Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline
Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline

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.

Other Name: Placebo condition




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [ Time Frame: From randomisation up to end of study (Week 24 after target quit date). ]
    The safety profile of electronic cigarette with nicotine comparatively to electronic cigarettes without nicotine and varenicline

  2. 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). ]
  3. 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). ]
  4. Change in cigarettes/day consumption [ Time Frame: From randomisation up to end of study (Week 24 after target quit date). ]
  5. French Tobacco Craving Questionnaire of 12 items (FTCQ-12) [ Time Frame: From randomisation up to end of study (Week 24 after target quit date). ]
    Change in craving for tobacco

  6. Minnesota Nicotine Withdrawal Scale [ Time Frame: From randomisation up to end of study (Week 24 after target quit date). ]
    Change in tobacco withdrawal symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630614


Contacts
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Contact: Ivan BERLIN, M.D., Ph.D. +33 1 42 16 16 78 ivan.berlin@aphp.fr

Locations
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France
Groupe Hospitalier Pitié-Salpétrière Recruiting
Paris, France, 75013
Contact: BERLIN Ivan         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03630614     History of Changes
Other Study ID Numbers: P150952J
2017-003588-37 ( EudraCT Number )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
smokers
electronic cigarette
nicotine
varenicline
randomized
double blind
double dummy
Additional relevant MeSH terms:
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Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action