Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: Inclusion Criteria:

* healthy smokers
* unwilling to quit
* age 18-60 years
* smoking ≥ 15 cig/day for at least 5 years
* exhaled CO level of ≥ 15 ppm
* FTND ≥ 5

Exclusion Criteria:

* alcohol and illicit drug use
* breastfeeding or pregnancy
* major depression or other psychiatric conditions
* previous experience with ENDD
* recent myocardial infarction
* angina pectoris
* high blood pressure (BP\>140mm Hg systolic and/or 90mmHg diastolic)
* diabetes mellitus
* severe allergies
* poorly controlled asthma or other airways diseases
B: Inclusion Criteria:

* Vitality beneficiary
* 18 years or older
* reported and/or tested positive for being a smoker
* all participants will be able to opt-out of this program.

Exclusion Criteria:

* Participants who express wanting to opt-out of this program will be un-enrolled and excluded
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:

* Age 21-65
* Smoke \>9 cigarettes per day for at least 1 year
* Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
* CO measurement \>9 ppm at baseline
* No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion \[used specifically as a quitting aid\], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
* Not planning to quit in the next 6 months
* Interested in reducing cigarette consumption
* Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
* Read and write in English
* Able to understand and consent

Exclusion Criteria:

* Pregnant and/or nursing women
* Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic \>159 or diastolic \>99 observed during screening).
* Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
* Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
* Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
* History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
* No surgery requiring general anesthesia in the past 6 weeks
* Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
* Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
* Use of hand-rolled, roll your own cigarettes
* Known allergy to propylene glycol or vegetable glycerin
* Other member of household is currently participating/participated in the study

Answer: A