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:

* 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.
B: Inclusion Criteria:

1. an ambulatory ICD-10 code for COPD in the last 12 months and a COPD Assessment Tool (CAT) score on the screening ≥10.
2. ages 21-75 (the legal age for purchasing e-cigarettes is 21)
3. current CC smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)
4. smokes at least 10 cigarettes per day on days they smoke CC
5. motivated to quit smoking (at least a 5 on a 10-point Likert scale)
6. Participants must be able to provide consent, agree to be randomized and followed-up with, a working telephone number and/or a system with teleconferencing capabilities (e.g. smartphone or computer), a phone with text messaging capabilities, and be willing to use an e-cigarette or NRT for 12 weeks. To reduce attrition, participants will be asked to provide one additional contact as a backup for follow up on appointments.

Exclusion Criteria:

1. A CAT score \>30 representing severe COPD
2. are pregnant (as determined by urine pregnancy test for women under age 52) or breastfeeding (self-reported). Women of childbearing age must also be willing to use an approved form of birth control during the course of the study if not practicing abstinence. Approved birth control methods include: hormonal birth control (e.g. "the pill"), barrier methods (e.g. condoms, diaphragm), and intrauterine devices (IUDs).
3. diagnosis of any medical condition (unstable angina/heart disease) or psychiatric condition precluding use of nicotine patch or gum as determined by the MD of this study, Dr. Scott Sherman (NYS license #171632), or by the subject's primary care doctor.
4. reporting using NRTs or e-cigarettes within the last 30 days
C: Inclusion Criteria:

* Study I - First Phase - No Longer Recruiting

  * Greater than 1 year history of daily smoking
  * 1 month or more of e-cigarette use
  * Able to speak and read English
  * (1) current dual users (of tobacco cigarettes and e-cigarettes) without interest in quitting smoking; (2) current dual users who have attempted, but not quit smoking; (3) current e-cigarette users who have successfully quit smoking; and (4) former dual users who have quit both products.
* Study I - Second Phase - No Longer Recruiting

  * Current dual users (of tobacco cigarettes and e-cigarettes)
  * Smoking at least one cigarette per day over the past year
  * Using e-cigarettes at least once per week over the past month
  * Not currently enrolled in a face-to-face smoking cessation program
  * Able to speak and read English
* Study II - No Longer Recruiting

  * Current dual users (of tobacco cigarettes and e-cigarettes)
  * Smoking at least one cigarette per week over the past year
  * Using e-cigarettes at least once per week over the past month
  * Not currently enrolled in a face-to-face smoking cessation program
  * Able to speak and read English
D: Inclusion Criteria for smoking intervention and weight management intervention:

* Participants must be Medicaid recipients receiving mental health treatment at one of the participating study sites in New Hampshire.
* 18 years or older

Additional Inclusion Criteria for smoking intervention only:

\*Smoking 5 or more cigarettes a day or a carbon monoxide level of 5 or higher at screening.

Additional Inclusion Criteria for weight management only:

\*Body Mass Index of 30 or higher or 25 or higher and sedentary lifestyle.

Exclusion Criteria for both interventions:

* Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
* Nursing home
* Inability to speak or understand English

Additional exclusion Criteria for weight management only:

* Previous participation in the In SHAPE program
* Active eating disorder diagnosis
* Pregnancy

Additional exclusion Criteria for smoking intervention only:

\*Active alcohol or drug dependence with use in the past 30 days

Answer: A