Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial
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.


Options:
A: Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of cardiovascular disease
* Myocardial infarction
* Significant arrhythmias
* Poorly controlled hypertension
B: Inclusion Criteria:

* Smokers aged 18 years or above and wanting to stop smoking
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
C: 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.
D: Inclusion Criteria:

* Informed Consent as documented by signature
* Persons aged 18 or older
* Currently smoking 5 or more cigarettes a day for at least 12 months
* Willing to try to quit smoking within the next 3 months,
* Persons providing a valid phone number, a valid email address and/or a valid postal address.

Exclusion Criteria:

* Known hypersensitivity or allergy to contents of the e-liquid
* Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
* Persons having used ENDS regularly in the 3 months preceding the baseline visit
* Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
* Persons who cannot attend the 6- month follow-up visit for any reason
* Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures

Answer: C