Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: Inclusion Criteria:

* Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
* State that they are under the care of a primary care physician
* Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Speak English
* Answer "no" to the following 3 questions:

  * "Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
  * "Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
  * "Is there any reason that you cannot use varenicline/Chantix?"

Exclusion Criteria:

* State that they are not under the care of a primary care physician
* Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Do not speak English
* Answer "yes" to the question, "have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
* Answer "yes" to the question, "have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
* Answer "yes" to the question, "is there any reason that you cannot use varenicline/Chantix?"
* Are women who are currently pregnant
* Report that they are unwilling to receive or take varenicline on screening
B: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects who have used bupropion (Zyban or Wellbutrin) previously.
C: Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"

Inclusion Criteria:

-Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"

Exclusion Criteria:

* History of seizure or head injury resulting in unconsciousness
* Any condition that might predispose to seizures (brain tumor or stroke)
* A current or history of anorexia nervosa or bulimia
* Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol
* Use of a protease inhibitor of MAO inhibitor within the last two week
* Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants
* Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol
* Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded
* Suicidal or homicidal ideation
* Current major depression
* History of bipolar disorder
* Recent (within twelve months) myocardial infarction
* Any other medical condition that would contraindicate use of NRT or bupropion
* Physical limitation so severe that participation in a program of moderate exercise is not possible
* Pregnancy or lactation
D: DISEASE CHARACTERISTICS:

* Smokes 10 or more cigarettes/day over the past year AND ≥ 5 cigarettes/day within the past week
* Planning to stop smoking in 4-6 weeks
* Member of Group Health Cooperative (GHC) and planning to stay enrolled for the next 6 months
* Eligible for the Free \& Clear program
* Enrolled in the COMPASS study using bupropion hydrochloride medication
* No prior participation in GHC's Free \& Clear smoking cessation program within the past 6 months

PATIENT CHARACTERISTICS:

* In good general health
* Sufficient verbal and written English
* Dependable access to a telephone and the Internet
* Not currently drinking ≥ 14 alcoholic drinks per week and/or binge drinking ≥ 2 times in the past month
* Not pregnant or nursing
* No plan to become pregnant
* No severe chronic heart disease (e.g, myocardial infarction within the past 3 months)
* No severe chronic obstructive pulmonary disease that ever required hospitalization or oxygen treatment
* No diagnosis of or treatment for a psychotic disorder (e.g., schizophrenia, bipolar disorder, or mania)
* Not having certain kidney problems

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent use of medications contraindicated with bupropion hydrochloride or known to lower seizure threshold (e.g., antidepressant, antipsychotic, monamine oxidase inhibitor, or protease inhibitor)
* No concurrent use of recreational or street drugs
* No concurrent use of bupropion hydrochloride or nicotine replacement therapy
* No concurrent cimetidine, metformin, phenformin, pindolol, procainamide
* Not on dialysis

Answer: B