Smoking CessationPhase 3NCT02417467
Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial
A Phase 3 study testing Nicotine E-Cigarette, Non-Nicotine E-Cigarette and Counseling in people with Smoking Cessation, run by McGill University at 16 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine E-Cigarette, Non-Nicotine E-Cigarette and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 16 sitesCanada
- Study dates
- Nov 2016to 1 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
Allen Greenspoon Medicine Profesionnal Corporation
Hamilton, Ontario, L8L 5G8
Baran Medicine Professional Corporation
Kingston, Ontario, K7M 1W9
Hôpital Cité-de-la-Santé
Laval, Quebec, H7M 3L9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3T1E2
Institut de recherche de l'Hôpital Montfort
Ottawa, Ontario, K1K 0T2
The Bridge Engagement Centre
Ottawa, Ontario, K1N 5N1
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Institut de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1J 3H5
Canadian Centre for Clinical Trials
Thornhill, Ontario, L4J 1W3
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
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.
Read the detailed description
- OVERALL STUDY OBJECTIVE The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) Trial is a 5-year, multi-centre, randomized controlled trial (RCT) that seeks to assess the efficacy, safety, and tolerability of nicotine and non-nicotine electronic cigarettes (e-cigarettes) for smoking cessation in the general population.
II. SPECIFIC OBJECTIVES
- To compare the efficacy of nicotine and non-nicotine e-cigarettes used with individual counselling for smoking cessation, to that of individual counselling alone, in terms of biochemically-validated 7-day point prevalence smoking abstinence at 52 weeks.
- To examine the effect of nicotine and non-nicotine e-cigarettes on other measures of smoking reduction and cessation, including continuous abstinence and daily cigarette consumption at 4, 12, 24, and 52 weeks.
- To describe the safety and tolerability of nicotine and non-nicotine e-cigarettes in terms of serious adverse events (SAEs), adverse events (AEs), drop-out rates due to side effects, and therapy adherence over the 12 week treatment period.
- RATIONALE 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 one year of abstinence. However, even using traditional 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 that is inhaled by the user, and is available in nicotine and non-nicotine varieties. Its mimicry of the act of smoking gives it the potential to target the habit-forming mechanism of smoking, and to mitigate withdrawal symptoms with nicotine replacement (in the case of nicotine e-cigarettes). However, e-cigarettes have not been approved for use for smoking cessation by Health Canada or the US Food and Drug Administration. Despite this, these devices are rising in popularity. A recent survey found that of smokers motivated to within 6 months, 48.5% had tried e-cigarettes. The E3 Trial will be the first conducted in the general population of Canadian smokers motivated to quit. It will also provide the longest-term (52 weeks) follow-up data on smoking reduction and cessation in smokers motivated to quit with the e-cigarette.
II. METHODS The investigators will conduct a multi-centre RCT with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 486 participants will be randomized to one of three treatment arms: (1) nicotine e-cigarettes with individual counselling, (2) non-nicotine e-cigarettes with individual counselling, or (3) individual counselling alone. Eligible participants will be recruited from the general population, be at least 18 years of age, will self-identify as regular smokers (≥10 cigarettes per day for at least one year), and be motivated to quit. Participants will complete telephone follow-ups at weeks 1, 2, and 8. The participants will also return for clinic visits at weeks 4, 12, 24, and 52. Biochemically-validated smoking abstinence will be measured at all clinic visits using exhaled carbon monoxide. At follow-up calls and visits, the investigators will collect information about self-reported smoking, e-cigarette use, withdrawal symptoms, and side effects. The primary analysis will compare point-prevalence abstinence at 52 weeks between participants randomized to nicotine e-cigarettes versus individual counselling alone. Similar analyses will be conducted to compare abstinence across other trial arms. In secondary analyses, the investigators will examine point-prevalence abstinence at other follow-ups, as well as the effect of treatment group on continuous abstinence, daily cigarette consumption, and the occurrence of clinical events and side effects. A sample size of 486 was identified through power calculation, based on a 52-week point prevalence abstinence rate of 10% among participants randomized to counselling, with >80% power to detect a ≥12% absolute difference in the prevalence of smoking abstinence at 52 weeks (e.g., a prevalence of abstinence in the nicotine e-cigarette group of 22%) with a two-tailed α of 0.05.
III. SIGNIFICANCE E-cigarettes are popular devices that may have the potential to facilitate smoking cessation. The E3 Trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.
IV. ADDENDUM The primary endpoint was changed from 52 weeks to 12 weeks following the early termination of enrollment (77% of target enrollment) due to a delay in product manufacturing.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine E-Cigarette, Non-Nicotine E-Cigarette, Counseling
- Keywords
- Electronic cigarette, E-cigarette, Smoking cessation
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine E-CigaretteOther
Non-Nicotine E-CigaretteOther
CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nicotine E-Cigarette; Behavioral: 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. Receives: Other: Non-Nicotine E-Cigarette; Behavioral: 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. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (6)
Number of participants with 7-day point prevalence smoking abstinence
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.
Measured: 4, 12, and 24 weeks
Number of participants with continuous abstinence from smoking
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.
Measured: 4, 12, 24, and 52 weeks
Change in daily cigarette consumption
Change in self-reported mean number of daily conventional cigarette consumption from baseline to weeks 1, 2, 4, 8, 12, 18, 24, and 52.
Measured: 1, 2, 4, 8, 12, 18, 24, and 52 weeks
The frequency of serious adverse events
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.
Measured: 12 weeks
The frequency of adverse events
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.
Measured: 12 weeks
The frequency of drop-outs
The number of drop-outs due to side effects of the e-cigarettes over the 12 week treatment period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
- Responsible party
- Principal investigator, Mark Eisenberg, McGill University
- Investigators
- Mark J Eisenberg, MD MPH, Principal investigator, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417467
- Sponsor's protocol ID
- E3
- Other IDs
- MOP-133727
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39283667Prell 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.
PubMed 37832989Hartmann-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.
PubMed 34611902Eisenberg 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.
PubMed 33170240
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial
- ClinicalTrials.gov ID
- NCT02417467
- Acronym / sponsor ID
- E3
- Conditions
- Smoking Cessation
- Keywords
- Electronic cigarette, E-cigarette, Smoking cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
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.
Detailed description
- OVERALL STUDY OBJECTIVE The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) Trial is a 5-year, multi-centre, randomized controlled trial (RCT) that seeks to assess the efficacy, safety, and tolerability of nicotine and non-nicotine electronic cigarettes (e-cigarettes) for smoking cessation in the general population.
II. SPECIFIC OBJECTIVES
- To compare the efficacy of nicotine and non-nicotine e-cigarettes used with individual counselling for smoking cessation, to that of individual counselling alone, in terms of biochemically-validated 7-day point prevalence smoking abstinence at 52 weeks.
- To examine the effect of nicotine and non-nicotine e-cigarettes on other measures of smoking reduction and cessation, including continuous abstinence and daily cigarette consumption at 4, 12, 24, and 52 weeks.
- To describe the safety and tolerability of nicotine and non-nicotine e-cigarettes in terms of serious adverse events (SAEs), adverse events (AEs), drop-out rates due to side effects, and therapy adherence over the 12 week treatment period.
- RATIONALE 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 one year of abstinence. However, even using traditional 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 that is inhaled by the user, and is available in nicotine and non-nicotine varieties. Its mimicry of the act of smoking gives it the potential to target the habit-forming mechanism of smoking, and to mitigate withdrawal symptoms with nicotine replacement (in the case of nicotine e-cigarettes). However, e-cigarettes have not been approved for use for smoking cessation by Health Canada or the US Food and Drug Administration. Despite this, these devices are rising in popularity. A recent survey found that of smokers motivated to within 6 months, 48.5% had tried e-cigarettes. The E3 Trial will be the first conducted in the general population of Canadian smokers motivated to quit. It will also provide the longest-term (52 weeks) follow-up data on smoking reduction and cessation in smokers motivated to quit with the e-cigarette.
II. METHODS The investigators will conduct a multi-centre RCT with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 486 participants will be randomized to one of three treatment arms: (1) nicotine e-cigarettes with individual counselling, (2) non-nicotine e-cigarettes with individual counselling, or (3) individual counselling alone. Eligible participants will be recruited from the general population, be at least 18 years of age, will self-identify as regular smokers (≥10 cigarettes per day for at least one year), and be motivated to quit. Participants will complete telephone follow-ups at weeks 1, 2, and 8. The participants will also return for clinic visits at weeks 4, 12, 24, and 52. Biochemically-validated smoking abstinence will be measured at all clinic visits using exhaled carbon monoxide. At follow-up calls and visits, the investigators will collect information about self-reported smoking, e-cigarette use, withdrawal symptoms, and side effects. The primary analysis will compare point-prevalence abstinence at 52 weeks between participants randomized to nicotine e-cigarettes versus individual counselling alone. Similar analyses will be conducted to compare abstinence across other trial arms. In secondary analyses, the investigators will examine point-prevalence abstinence at other follow-ups, as well as the effect of treatment group on continuous abstinence, daily cigarette consumption, and the occurrence of clinical events and side effects. A sample size of 486 was identified through power calculation, based on a 52-week point prevalence abstinence rate of 10% among participants randomized to counselling, with >80% power to detect a ≥12% absolute difference in the prevalence of smoking abstinence at 52 weeks (e.g., a prevalence of abstinence in the nicotine e-cigarette group of 22%) with a two-tailed α of 0.05.
III. SIGNIFICANCE E-cigarettes are popular devices that may have the potential to facilitate smoking cessation. The E3 Trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.
IV. ADDENDUM The primary endpoint was changed from 52 weeks to 12 weeks following the early termination of enrollment (77% of target enrollment) due to a delay in product manufacturing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine E-Cigarette and Counseling | Experimental | Other: Nicotine E-Cigarette, Behavioral: CounselingAs 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. |
| Non-Nicotine E-Cigarette and Counseling | Other | Other: Non-Nicotine E-Cigarette, Behavioral: CounselingParticipants 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. |
| Counseling | Other | Behavioral: CounselingSmoking 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Nicotine E-Cigarette | Other | Nicotine E-Cigarette and Counseling |
| Non-Nicotine E-Cigarette | Other | Non-Nicotine E-Cigarette and Counseling |
| Counseling | Behavioural | Counseling, Nicotine E-Cigarette and Counseling, Non-Nicotine E-Cigarette and Counseling |
Primary outcome
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.
6 secondary outcomes
Number of participants with 7-day point prevalence smoking abstinence
Time frame: 4, 12, and 24 weeks
Number of participants with continuous abstinence from smoking
Time frame: 4, 12, 24, and 52 weeks
Change in daily cigarette consumption
Time frame: 1, 2, 4, 8, 12, 18, 24, and 52 weeks
The frequency of serious adverse events
Time frame: 12 weeks
The frequency of adverse events
Time frame: 12 weeks
The frequency of drop-outs
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 39283667Lyzwinski 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.
- Derived from this study: PubMed 37832989Prell 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.
- Derived from this study: PubMed 34611902Hartmann-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.
- Derived from this study: PubMed 33170240Eisenberg 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.
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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.
Mark J Eisenberg, MD MPH principal investigator
McGill University, Jewish General Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine E-Cigarette, Non-Nicotine E-Cigarette and Counseling in people with Smoking Cessation, run by McGill University at 16 sites in Canada.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with 7-day point prevalence smoking abstinence (time frame: 52 weeks). 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 NCT02417467, which also lists 4 linked publications.
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 28 Jan 2021.