Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Inclusion Criteria:

* age \>=18 years; smoking \>4 cigarettes/day for the previous 6 months; able to read, write, and speak English; have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts; and if currently using NRT, agreeing to use only study medication for the duration of the study. We will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses); not currently attempting to quit smoking; not intending to quit smoking (defined as no plans to quit in the next month); and planning to remain in the intervention catchment area for at least 12 months.

Exclusion Criteria:

* currently taking bupropion or varenicline; medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days; diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years; and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
B: Inclusion Criteria:

* 18-65 years old
* smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
* expired carbon monoxide reading of at least 15ppm
* express a desire to quit smoking in the next 30 days

Exclusion Criteria:

* Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
* Hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg).
* Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Lung disorder (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* History of migraine headaches in the past 5 years;
* History of fainting;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, Obsessive-compulsive disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score \>9 (or who score \>0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
* Bulimia or anorexia;
* Pregnant or nursing mothers;
* Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
* Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
* Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
* Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse. Potential participants will be asked the first two questions on the AUDIT questionnaire during the phone screen. If the person scores "4" on both questions, a screening appointment will not be scheduled. During the screening session the entire AUDIT questionnaire will be administered. Females who score greater than or equal to 13 and males who score greater than or equal to 15 will be excluded from the study.
* Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the past
C: Inclusion Criteria:

* Men and women
* 18 to 75 yrs old
* Motivated to stop smoking
* Smoke at least 10 cigarettes/day

Exclusion Criteria:

* Active psychiatric disease
* Severe or unstable cardiovascular or pulmonary disease
* Current or recent treatment to stop smoking
* Previous use of varenicline
D: Inclusion Criteria:

* ≥ 18 years of age
* Smoke at least 10 cigarettes/day for the past year
* Suffered an enzyme-positive ACS
* Planned hospitalization of ≥24 hours
* Motivated to quit smoking
* Likely to be available for follow-up
* Able to understand and read English or French

Exclusion Criteria:

* Medical condition with a prognosis of \< 1 year
* Pregnant or lactating
* Current use of Wellbutrin or any other medications that contain bupropion
* Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)
* Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)
* History of bulimia or anorexia nervosa
* Current diagnosis of major depression (requiring medication), bipolar disease, or dementia
* History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels ≥ 2 times upper limit of normal prior to admission for ACS)
* Renal impairment with creatinine levels ≥ 2 times the upper limit of normal
* Excessive alcohol consumption defined as ≥ 14 alcoholic drinks per week
* Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates)
* Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinolone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)
* Use of MAO inhibitors or thioridazine in the past 15 days
* Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anoretics

Answer: C