Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Inclusion Criteria:

* daily smoker
* 5+ cigarettes per day for at least one year
* expired carbon monoxide level of 5+ ppm

Exclusion Criteria:

* current use of smoking cessation pharmacotherapies
* current or history of psychotic disorder
* current major depressive disorder
* history of suicidal ideation in the previous 3 months
* unstable medical condition
* pregnant, nursing, or planning to become pregnant
* planning to move from study area within 18 months
B: Inclusion Criteria:

* 18-65 years old;
* smoked an average of at least 10 cigarettes per day for three cumulative years;
* have an expired air CO reading assessed at screening of at least 10ppm;
* express a desire to quit smoking within the next 30 days.

Exclusion Criteria:

* Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
* Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg).
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Pregnant or nursing mothers;
* Alcohol abuse;
* Use of Opiate medications for pain or sleep in the past 14 days;
* Significant adverse reaction to nicotine patches, nicotine inhalers, bupropion / Wellbutrin / Zyban or Chantix / Varenicline in the past.
* Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), cigars, pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
C: Inclusion Criteria:

* Smokes at least 10 cigarettes per day for at least the past 2 years
* Meets DSM-IV criteria for nicotine dependence, as determined by the Fagerstrom Nicotine Tolerance Questionnaire
* Meets DSM-IV diagnoses of unipolar depressive disorders (major depression, dysthymia, and minor depression)

Exclusion Criteria:

* Current suicidal or homicidal risk
* Serious illness, including cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or hematologic disease
* Untreated peptic ulcer
* Life-threatening arrhythmia, cerebrovascular, or cardiovascular event within the 6 months prior to enrollment
* Severe respiratory compromise, as defined as a FEV-1 less than 1.0 L/min and/or pO2 less than 60 or pCO2 less than 45
* Currently using nicotine-containing products (e.g., cigar, pipe, snuff, nicotine gum)
* History of a seizure disorder
* Current DSM-IV diagnosis of organic mental disorder, schizophrenia, delusional disorder, psychotic disorder, bipolar disorder, or antisocial personality disorder
* Current DSM-IV diagnosis of substance abuse or dependence disorders within the year prior to enrollment
* Current eating disorder, including anorexia nervosa and bulimia nervosa
* History of multiple adverse drug reactions or allergy to bupropion
* Mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs (with the exception of hypnotics and benzodiazepines at stable doses for at least six months prior to enrollment or current use of nonbenzodiazepine hypnotics such as Ambien and Sonata)
* Clinical or laboratory evidence of hypothyroidism
* Currently seeking treatment for smoking cessation
* History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, or tapes
* Currently using topical drugs
* Pregnant
* Not using adequate methods of contraception
D: Inclusion Criteria:

* Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence
* Young Mania Rating Scale Total Score \<12 at study entry
* HAM-D 17-Item Score \>5 and \<24 at study entry
* Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher
* Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test"
* Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level \>10 ppm and a plasma cotinine level \>150 ng/ml at baseline)
* Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool
* On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic)
* Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment

Exclusion Criteria:

* Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment
* Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis
* Meet DSM-IV criteria for current major depression at the time of baseline evaluation
* A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline.
* Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities)
* EKG abnormalities
* Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers
* Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide
* Prescription of varenicline
* Prescription of bupropion SR
* The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment.
* A lifetime history of antidepressant-induced mania or hypomania
* A history of suicidal ideation while taking antidepressants

Answer: A