Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.


Options:
A: Inclusion Criteria:

* Women and men aged 18-70
* DSM-IV diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder by diagnostic interview and chart review
* Smoke at least 10 cigarettes per day
* Clinically stable, on a stable dose of antipsychotic (schizophrenia) or mood stabilizer (bipolar) medication for at least 1 month
* No current active suicidal ideation
* Expired air carbon monoxide (CO) concentration \>9 ppm
* Willing to take study medications and set a quit date within 2-3 weeks of beginning treatment and be willing to participate in the relapse prevention and follow-up portions of the study
* Women of childbearing potential must have a negative urine pregnancy test at baseline and agree to use an approved form of contraception during the study.

Exclusion Criteria:

* DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder
* Substance use disorder other than nicotine or caffeine in the last 6 months
* Major depressive disorder within the last 6 months
* Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months
* Life-threatening arrhythmia or cerebro-vascular event within 6 months, cardiovascular event within 2 months or uncontrolled hypertension
* History of multiple head injuries with neurological sequelae, a single severe head injury with lasting neurological sequelae, or current CNS tumor
* Liver function tests elevated over twice normal
* Renal insufficiency with estimated creatinine clearance \<40 ml/min
* Plan to continue use of tobacco products othe than cigarettes (e.g., cigar, pipe)
* Use of an investigational medication or device in the past 30 days
* Current suicidal or homicidal ideation
B: 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
C: Inclusion Criteria:

* Subjects must have smoked an average of at least 15 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 with clinically significant cardiovascular disease in the past 6 months.
D: Inclusion Criteria:

* Smoke \>4 cigarettes/day for at least 6 months
* Age 21+
* Want to quit and ready to try in next 30 days
* Willing to quit all forms of tobacco (including e-cigs)
* Willing to use Chantix to try to quit
* Have a cell phone able to receive text messages
* Willing to attend 3 visits and use varenicline for smoking cessation
* Plan to live in local area for next 6 months
* Read and write in English
* Women not pregnant and taking steps to avoid
* Able to understand and willing to sign consent

Exclusion Criteria:

* History of allergic reaction or other adverse event while using varenicline
* Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
* Currently pregnant or nursing
* Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
* Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
* Uses non-cigarette tobacco products and does not plan to quit all tobacco.
* Has a history of kidney problems or receives dialysis
* Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks
* Had a heart attack in the past 4 weeks
* Mental conditions that would prohibit the participant from completing the protocol

Answer: B