Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
Brief Summary: The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.


Options:
A: Inclusion Criteria:

* The investigators will recruit patients who are assessed in preadmission clinic and scheduled for elective surgical procedures within the next 8 to 30 days.
* Patients should be 18 yrs of age, have smoked an average 10 cigarettes/day or more during the previous year and had no period of smoking abstinence longer than 3 months in the past year.

Exclusion Criteria:

* current pregnancy, breastfeeding;
* major depression, panic disorder, psychosis, or bipolar disorder within the prior year;
* use of nicotine replacement or bupropion within the previous 3 months;
* cardiovascular disease within the past 6 months;
* a serious or unstable disease within the past 6 months;
* drug or alcohol abuse or dependence within the past year;
* and use of tobacco products other than cigarettes or marijuana use within the previous month;
* participating in any other studies
* Patients who cannot understand English or have any form of cognitive impairment will be excluded.
B: Inclusion Criteria:

* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria:

* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
C: 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
D: Inclusion Criteria:

* At least 18 years old
* Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
* Daily smoker
* Smoke at least 8 cigarettes per day
* No reduction in smoking in last 30 days
* No intention to quit in the next 30 days
* Never used Varenicline before
* Not currently using smoking cessation medications or nicotine replacement therapy
* Willing to use Varenicline for at least 2 weeks
* Fluent in English

Exclusion Criteria:

* Cannot be currently pregnant or breastfeeding
* Kidney disease
* Frequent nausea
* On certain medications for asthma and/or depression
* Another household member in study

Answer: C