Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Inclusion Criteria:

1. Age 18-65, male or female
2. Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
3. Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
4. Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
5. Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
6. Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
7. Reports not quitting smoking in the past three months for more than one week duration
8. Agrees to attend behavioral counseling sessions and complete study measures
9. Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend

Exclusion Criteria:

1. Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
2. Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
3. Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
4. Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
5. Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
6. History of adverse reaction to opioid antagonist or nicotine replacement treatment
7. Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
8. Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
9. Unwillingness to agree to DNA analysis.
B: Inclusion Criteria:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)
C: Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
D: Inclusion Criteria:

1. Current daily smoker \>10 or more cigarettes per day
2. Having smoked (on average \> 10 cigarettes/day) regularly for at least 3 years
3. Age between 18 and 65 years
4. Sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the Swiss Baseline Questionnaire.

Exclusion Criteria:

1. Current pharmacological agent use to quit smoking
2. Medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems
3. Presence of an unstable medical condition
4. Current or recent major cardiovascular event, such as recent myocardial infarction (\>12 months) or stroke, angina pectoris, major arrhythmia
5. Current psychiatric illness
6. Alcohol (\> 4 drinks/day for men and \> 3 drink/d. for women), or/and other substance abuse
7. Current or planned pregnancy
8. Systematic skin disease

Answer: B