NCT02417467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2016

Typical duration for phase_3

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

April 1, 2015

Last Update Submit

January 27, 2021

Conditions

Smoking Cessation

Keywords

Electronic cigaretteE-cigaretteSmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with 7-day point prevalence smoking abstinence

    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.

    52 weeks

Secondary Outcomes (6)

  • Number of participants with 7-day point prevalence smoking abstinence

    4, 12, and 24 weeks

  • Number of participants with continuous abstinence from smoking

    4, 12, 24, and 52 weeks

  • Change in daily cigarette consumption

    1, 2, 4, 8, 12, 18, 24, and 52 weeks

  • The frequency of serious adverse events

    12 weeks

  • The frequency of adverse events

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

Nicotine E-Cigarette and Counseling

EXPERIMENTAL

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-CigaretteBehavioral: Counseling

Non-Nicotine E-Cigarette and Counseling

OTHER

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-CigaretteBehavioral: Counseling

Counseling

OTHER

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

Interventions

Nicotine E-CigaretteOTHER
Nicotine E-Cigarette and Counseling
Non-Nicotine E-CigaretteOTHER
Non-Nicotine E-Cigarette and Counseling
CounselingBEHAVIORAL
CounselingNicotine E-Cigarette and CounselingNon-Nicotine E-Cigarette and Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Allen Greenspoon Medicine Profesionnal Corporation

Hamilton, Ontario, L8L 5G8, Canada

Location

Baran Medicine Professional Corporation

Kingston, Ontario, K7M 1W9, Canada

Location

Institut de recherche de l'Hôpital Montfort

Ottawa, Ontario, K1K 0T2, Canada

Location

The Bridge Engagement Centre

Ottawa, Ontario, K1N 5N1, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Canadian Centre for Clinical Trials

Thornhill, Ontario, L4J 1W3, Canada

Location

Michael Garron Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hôpital Cité-de-la-Santé

Laval, Quebec, H7M 3L9, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Institut de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1J 3H5, Canada

Location

Related Publications (4)

  • Lyzwinski L, Dong M, Wolfinger RD, Filion KB, Eisenberg MJ. e-Cigarettes, Smoking Cessation, and Weight Change: Retrospective Secondary Analysis of the Evaluating the Efficacy of e-Cigarette Use for Smoking Cessation Trial. JMIR Public Health Surveill. 2024 Sep 16;10:e58260. doi: 10.2196/58260.

    PMID: 39283667DERIVED

  • Prell C, Hebert-Losier A, Filion KB, Reynier P, Eisenberg MJ. Evaluating the impact of varying expired carbon monoxide thresholds on smoking relapse identification: insights from the E3 trial on e-cigarette efficacy for smoking cessation. BMJ Open. 2023 Oct 13;13(10):e071099. doi: 10.1136/bmjopen-2022-071099.

    PMID: 37832989DERIVED

  • Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

    PMID: 34611902DERIVED

  • Eisenberg MJ, Hebert-Losier A, Windle SB, Greenspoon T, Brandys T, Fulop T, Nguyen T, Elkouri S, Montigny M, Wilderman I, Bertrand OF, Bostwick JA, Abrahamson J, Lacasse Y, Pakhale S, Cabaussel J, Filion KB; E3 Investigators. Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2020 Nov 10;324(18):1844-1854. doi: 10.1001/jama.2020.18889.

    PMID: 33170240DERIVED

MeSH Terms

Conditions

Smoking CessationVaping

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mark J Eisenberg, MD MPH

    McGill University, Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 15, 2015

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

October 1, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

CA(16)