Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
Brief Summary: Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3


Options:
A: 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)
B: Inclusion Criteria:

* African American
* 18-75 years of age
* Smoke more than 10 cigarettes per day
* Have a functioning telephone number
* Be interested in quitting smoking
* Be willing to take 3 months of Chantix
* Be willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to Chantix
* Cardiovascular event in the past month
* History of alcohol or drug abuse/dependency in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder
* Psychosis, bipolar or eating disorder
* Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone
* Use of tobacco products other than cigarettes
* Use of nicotine replacement therapy, bupropion, clonidine or nortriptyline in the month prior to enrollment
* Prior use of Chantix
* Women who are pregnant, contemplating getting pregnant or breastfeeding
* Plans to move from Kansas City during the 3 month treatment phase
* Another household member enrolled in the study
C: Inclusion Criteria:

1. Between the ages of 18 and 75.
2. Smoking 5 or more cigarettes per occasion at least 3 times per week.
3. Fewer than 3 months of smoking abstinence in the past year.
4. Motivated to stop smoking.
5. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion.

Exclusion Criteria:

1. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
2. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
3. Clinically significant cardiovascular disease
4. Uncontrolled hypertension
5. Hepatic or renal impairment
6. Severe chronic obstructive pulmonary disease
7. Diabetes mellitus requiring insulin or oral hypoglycemic medications.
8. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
9. History of cancer (except treated basal cell or squamous cell carcinoma of the skin).
10. History of clinically significant allergic reactions.
11. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or substantial suicide or violence risk) by history or psychological examination)
12. Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.
13. Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of \> 8, c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal.
14. Use of another investigational drug within 30 days.
15. Intention to donate blood or blood products during the treatment phase of the study.
16. Use of tobacco products other than cigarettes or use of marijuana.
17. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment or intention to use medication that might interfere with study medication.
18. Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg.
19. Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
D: Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of clinically significant cardiovascular disease
* Uncontrolled hypertension

Answer: B