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Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial

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ClinicalTrials.gov Identifier: NCT02417467
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Mark Eisenberg, McGill University

Brief Summary:

Smoking-related diseases contribute to the death of more than 37,000 Canadians annually. Of that number, almost one-third die of cardiovascular-related causes. Smoking cessation can decrease the additional risk of heart disease by 50% after 1 year. However, even using smoking cessation therapies, only 10-20% of smokers will be able to successfully quit smoking long-term. Therefore, new and alternative treatments are needed.

The e-cigarette is a battery-powered device approximately the size and shape of a cigarette that creates a smoke-free vapour which is inhaled by the user. Since it feels like smoking a cigarette, using the e-cigarette may help some smokers quit. Some e-cigarettes also contain nicotine, which can reduce withdrawal symptoms from quitting smoking. However, e-cigarettes have not been approved for use for smoking cessation by Health Canada or the FDA. Despite this, these devices are rising in popularity. A recent US Centers for Disease Control survey found that of smokers who were motivated to quit within the next 6 months, 48.5% had tried e-cigarettes.

The Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial will be the first large trial to address the important issue of e-cigarettes for smoking cessation in Canada. The trial will randomly assign participants to receive nicotine e-cigarettes and minimal counseling, non-nicotine e-cigarettes and minimal counseling, or only minimal counseling for 12 weeks. Participants will then be followed for one year to see which (if any) group is more likely to have quit or reduced their smoking. Information about potential side effects and safety will also be collected. The E3 Trial will provide law-makers and the public with important information about the use of e-cigarettes for smoking cessation.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Nicotine E-Cigarette Other: Non-Nicotine E-Cigarette Behavioral: Counseling Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial
Study Start Date : November 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotine E-Cigarette and Counseling

As with standard nicotine replacement therapies, participants are expected to self-regulate administration of nicotine e-cigarettes according to their withdrawal symptoms. The manufacturer recommends each vaping session to last approximately 10 puffs, with one puff every 30 seconds over a span of approximately 4.5 minutes.

Smoking cessation/relapse prevention counselling will be provided for a minimum of 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15 minutes at clinic visits (20 minutes at week 4). Counselling will consist of a number of approaches, including reviewing smoking history, development/revision of a quit plan, encouragement of self-monitoring, review of triggers and challenges, and skill development.

Other: Nicotine E-Cigarette
Behavioral: Counseling
Non-Nicotine E-Cigarette and Counseling

Participants are expected to self-regulate administration of e-cigarettes. The manufacturer recommends each vaping session to last approximately 10 puffs, with one puff every 30 seconds over a span of approximately 4.5 minutes.

Smoking cessation/relapse prevention counselling will be provided for a minimum of 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15 minutes at clinic visits (20 minutes at week 4). Counselling will consist of a number of approaches, including reviewing smoking history, development/revision of a quit plan, encouragement of self-monitoring, review of triggers and challenges, and skill development.

Other: Non-Nicotine E-Cigarette
Behavioral: Counseling
Counseling
Smoking cessation/relapse prevention counselling will be provided for a minimum of 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15 minutes at clinic visits (20 minutes at week 4). Counselling will consist of a number of approaches, including reviewing smoking history, development/revision of a quit plan, encouragement of self-monitoring, review of triggers and challenges, and skill development.
Behavioral: Counseling



Primary Outcome Measures :
  1. Number of participants with 7-day point prevalence smoking abstinence [ Time Frame: 52 weeks ]

    The primary outcome measure is 7-day point prevalence smoking abstinence at 52 weeks. Smoking abstinence for this measure is defined as self-report smoking abstinence for the previous 7 days, and a measurement of exhaled carbon monoxide less than 11 ppm, at 52 weeks.

    The primary end point will be analyzed on an intention-to-treat (ITT) basis.This ITT analysis assumes that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials.



Secondary Outcome Measures :
  1. Number of participants with 7-day point prevalence smoking abstinence [ Time Frame: 4, 12, and 24 weeks ]
    Biochemically-validated 7-day point prevalence smoking abstinence at 4, 12 and 24 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide less than 11 ppm.

  2. Number of participants with continuous abstinence from smoking [ Time Frame: 4, 12, 24, and 52 weeks ]
    Biochemically-validated continuous abstinence at 4, 12, 24, and 52 weeks, defined as self-reported abstinence since baseline with exhaled carbon monoxide less than 11 ppm at all follow-up clinic visits.

  3. Change in daily cigarette consumption [ Time Frame: 1, 2, 4, 8, 12, 18, 24, and 52 weeks ]
    Change in self-reported mean number of daily conventional cigarette consumption from baseline to weeks 1, 2, 4, 8, 12, 18, 24, and 52.

  4. The frequency of serious adverse events [ Time Frame: 12 weeks ]

    The number of serious adverse events (SAE) reported over the 12 week treatment period.

    A SAE is defined as an adverse event which requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life-threatening, or that results in death.

    These SAEs will be reported to the Institutional Review Board, a Data and Safety Monitoring Board (DSMB), and Health Canada, as appropriate. The DSMB will provide oversight of safety and will establish stopping criteria for the trial at their first meeting. An Endpoints Evaluation Committee will be responsible for the evaluation and classification of all SAEs.


  5. The frequency of adverse events [ Time Frame: 12 weeks ]
    The number of adverse events reported over the 12 week treatment period. An adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the trial drug, whether or not considered related to the e-cigarettes.

  6. The frequency of drop-outs [ Time Frame: 12 weeks ]
    The number of drop-outs due to side effects of the e-cigarettes over the 12 week treatment period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active smoker, 10 or more cigarettes per day, on average, for the past year;
  • Age of 18 years or older;
  • Motivated to quit according to the Motivation To Stop Scale (MTSS) (level 5 or higher);
  • Able to understand and to provide informed consent in English or French;
  • Likely to be available for follow-up (1 year).

Exclusion Criteria:

  • Medical condition with a prognosis < 1 year;
  • Current or recent cancer (less than 1 year in remission);
  • Pregnant or lactating females;
  • Current or recent use (in the past 30 days) of any pharmacotherapy or behavioural therapy for smoking cessation (e.g., Nicotine Replacement Therapies, bupropion, varenicline, or counseling);
  • Any e-cigarette use (nicotine or non-nicotine) in the past 60 days, or ever use of any e-cigarette for more than 7 days consecutively;
  • History of psychosis, schizophrenia, or bipolar disorder;
  • Less than one month following a myocardial infarction, life-threatening arrhythmia, severe or worsening angina pectoris, or cerebral vascular accident;
  • Use of any illegal drugs in the past year (excluding marijuana);
  • Planned use of tobacco products other than conventional cigarettes (e.g., cigarillos, cigars, snuff, shisha, etc.) or marijuana during the study period.

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): NCT02417467


Locations
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Canada, Alberta
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Allen Greenspoon Medicine Profesionnal Corporation
Hamilton, Ontario, Canada, L8L 5G8
Baran Medicine Professional Corporation
Kingston, Ontario, Canada, K7M 1W9
Institut de recherche de l'Hôpital Montfort
Ottawa, Ontario, Canada, K1K 0T2
The Bridge Engagement Centre
Ottawa, Ontario, Canada, K1N 5N1
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Canadian Centre for Clinical Trials
Thornhill, Ontario, Canada, L4J 1W3
Michael Garron Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hôpital Cité-de-la-Santé
Laval, Quebec, Canada, H7M 3L9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Institut de cardiologie et de pneumologie de Québec (IUCPQ)
Quebec City, Quebec, Canada, G1V 4G5
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1J 3H5
Sponsors and Collaborators
McGill University
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: Mark J Eisenberg, MD MPH McGill University, Jewish General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mark Eisenberg, Professor of Medicine, McGill University
ClinicalTrials.gov Identifier: NCT02417467    
Other Study ID Numbers: E3
MOP-133727 ( Other Grant/Funding Number: CIHR )
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Keywords provided by Mark Eisenberg, McGill University:
Electronic cigarette
E-cigarette
Smoking cessation
Additional relevant MeSH terms:
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Nicotine
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