Please select the eligibility criteria that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Inclusion Criteria:

1. Type 2 diabetic patients (≤ 75 years of age) who are regular smokers (≥10 cigs/day during the past year, with no period of abstinence greater than three months in the past year) and willing to quit.
2. Females of non childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception.
3. Subjects must be able to be outpatients and be assessed in a clinic setting.
4. Participating subjects must be able to provide written informed consent.

Exclusion Criteria:

1. Subjects currently or within the past 12 months requiring treatment for depression. Subjects with a past or present history of panic disorder, psychosis, or bipolar disorder;
2. Subjects with a current or recent (within the past 12 months) history of alcoholism;
3. Subjects with a requirement to use other medications during the study that might interfere with the evaluation of the study drug (e.g., nicotine replacement therapy);
4. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing indoor clothing without shoes and determined using the Body Mass Index (BMI);
5. Subjects with evidence or history of clinically significant allergic (except for seasonal allergies at time of dosing), endocrine, gastrointestinal, hematological, hepatic, neurologic, pulmonary, or renal disease or a history of cancer (excluding treated basal cell carcinoma and squamous cell carcinoma). Exceptions to this exclusion may include subjects with a history of mild chronic obstructive pulmonary disease, and stable thyroid disease.
6. Subjects with a history of clinically significant cardiovascular disease. In addition, subjects with uncontrolled hypertension or a screening or baseline systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg will be excluded.
B: Inclusion Criteria:

* Age 18-60
* DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment
* Sufficient understanding of the study and risks (ESC score 10 or above)

Exclusion Criteria:

* Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
* History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
* DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana
* On nicotine replacement therapy (nicotine patch, gum, or nasal spray)
* Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)
* EKG of second or third degree atrioventricular (AV) block
* Renal insufficiency with estimated creatinine clearance \<40 ml/min
* Women who have positive urine pregnancy tests
* Women who are pregnant, plan to become pregnant, or in breastfeeding
C: We are only recruiting by invitation only (to members of our past cohort). We will open up enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

Inclusion Criteria:

a. To be eligible for the Comparative effectiveness trial, participants must:

* smoke 5 or more cigarettes per day,
* desire to quit smoking but not be currently engaged in cessation treatment,
* be medically eligible to use either combination NRT or varenicline,
* have reliable phone access,
* if female, must not be pregnant and must be willing to use an acceptable birth control method.

Exclusion Criteria:

1. There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
2. All smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:

   * end-stage renal disease with hemodialysis;
   * prior suicide attempts within the last 5 years or current suicidal ideation;
   * diagnosis of and/or treatment for schizophrenia;
   * other psychotic disorders or bipolar disorder within the last 10 years;
   * current PHQ-9 score indicative of moderately severe depression;
   * severe untreated hypertension \>200/100 mmHg;
   * currently taking Wellbutrin, Zyban or bupropion;
   * hospitalized for a stroke, heart attack, congestive heart failure or diabetes within the last year;
   * used pipe tobacco, cigars, snuff or chew more than twice in the past week.

It should be noted that if any incidental findings appear in any of the cardiology tests (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental Information section of application), the study cardiologist (Dr. Stein or his designee) will be assign the participant to the non-randomized treatment arm and they will be given the nicotine patch and the same counseling intervention as CET participants. They will not be included in the CET analyses. This will be done to properly address the cardiovascular risk warning from the FDA regarding varenicline (Chantix).
D: Inclusion Criteria:

* Smokes at least 10 cigarettes per day
* Good general health
* Negative pregnancy test prior to study entry

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine
* Known allergic reaction to alum or any of the components of the vaccine
* Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response
* Cancer or cancer treatment in the last 5 years
* HIV infection
* History of drug or alcohol abuse or dependence within 12 months
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease
* Previous intolerance to varenicline
* Inability to fulfill all visits for approximately 54 weeks

Answer: B