Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial
Brief Summary: The EVITA study is a clinical trial that will test the effect of varenicline (Champix™), a new drug used to help people quit smoking, in patients who have suffered a heart attack. Varenicline has been recently shown to increase the number of otherwise healthy people who quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce smoking in healthy populations, its effectiveness in patients recovering from a heart attack is unknown. The EVITA trial will help answer this question.

A total of 300 patients who have recently suffered a heart attack and are active smokers will be recruited in the study. For twelve weeks, half the patients will receive varenicline and the other half will receive placebo pills. Patients will be followed for a period of 12 months. During this time, patients will receive telephone calls and go to clinic visits in order to assess if they are smoking. These follow-ups will also assess any side effects and clinical events such as another heart attack or hospitalization that patients may have had. Smoking cessation will be checked using exhaled carbon monoxide readings and self-reports.

The EVITA trial will be the first study to examine the use of varenicline in patients who have recently had a heart attack. These patients, if they continue to smoke, are at high risk of having another cardiac event. If varenicline is shown to be useful in this population, it will have a major impact on prevention of cardiac events in patients who have suffered a heart attack.


Options:
A: 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.
B: Inclusion Criteria:

* Active smoker, greater than or equal to 10 cigarettes per day, on average, for the past year.
* Age greater than or equal to 18 years.
* Motivated to quit smoking.
* Able to understand and to provide informed consent in English or French.
* Likely to be available for follow-up.
* Suffered an ACS, including myocardial infarction (MI) or unstable angina (UA) with significant coronary artery disease, and currently hospitalized or at discharge from current hospitalization.

MI is defined as positive Troponin T, Troponin I, or CK-MB levels and ≥ 1 of the following:

1. Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes.
2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression).
3. Development of pathological Q waves on the ECG.

UA with significant coronary artery disease is defined as all of the following:

1. Negative Troponin T, Troponin I, or CK-MB levels;
2. Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes;
3. ECG changes indicative of ischemia (ST-segment changes); and
4. At least one lesion ≥ 50% on angiogram performed during the current hospitalization.

Exclusion Criteria:

* Medical condition with a prognosis of \< 1 year.
* Pregnant or lactating females.
* Reported NYHA Class or Killip III or IV at randomization.
* Previous use of varenicline.
* Current use of any medical therapy for smoking cessation (e.g. BuSpar, doxepin,fluoxetine, nicotine gum, nicotine patch, or bupropion).
* History of bulimia or anorexia nervosa.
* Diagnosis of major depression (requiring medication) in the previous 5 years or diagnosis of two or more lifetime episodes of major depression (requiring medication)
* A total of 5 or more responses (one of which includes question 1 or 2) of "more than half the days" or "nearly every day" to the questions on the PHQ-9 questionnaire.
* History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide.
* History of or current panic disorder, psychosis, bipolar disease, or dementia.
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels greater than or equal to 2 times upper limit of normal prior to admission for ACS).
* Renal impairment with creatinine levels greater than or equal to 2 times the upper limit of normal.
* Excessive alcohol consumption defined as greater than or equal to 14 alcoholic drinks per week.
* Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates).
* Use of any marijuana or other tobacco products during the study.
* Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anorectics.
C: Inclusion Criteria:

* diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);
* age between 18 and 65 years old;
* on stable antipsychotic medication treatment for at least one month;
* BMI \> 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or BMI\>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over 90cm;
* smoking at least 10 cigarettes daily for one year or longer;
* desire to lose weight and quit smoking.

Exclusion Criteria:

* Binge eating or other eating disorders;
* Current use of weight loss or antidiabetic medications;
* Current substance use (except nicotine or caffeine);
* Elevated hepatic transaminase levels (\>2.5x normal range);
* Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;
* History of seizure disorder;
* History of unstable cardiac problems or other unstable medication conditions;
* Being pregnant or nursing (for women).
D: Inclusion Criteria:

* 18-65 years old;
* Smoke an average of at least 10 cigarettes per day;
* Have smoked at least one cumulative year;
* Have an expired air CO reading of at least 10ppm;
* Body weight of \>50 kg (110 lbs.)
* Able to read and understand English;
* Express a desire to quit smoking in the next thirty 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).
* Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
* Coronary heart disease, diagnosed by coronary angiogram;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pain in the last month (unless history, exam, and ECG clearly indicate a non-cardiac source);
* Symptomatic cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* Diagnosis of liver disease or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems (e.g. Celiac disease, Crohn's dx Ulcerative Colitis) 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 (unless controlled by diet and exercise alone and screening 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);
* HIV, Hepatitis B, or Hepatitis C
* History of tuberculosis or recent positive purified protein derivative (PPD) test
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
* Suicidal ideating (thinking about ways to commit suicide) (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score \>9 (or who score \>0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
* Bulimia or anorexia;
* BMI of \< 18.5 kg/m2;
* Prior use of fenfluramine or dexfenfluramine
* Use (within the past 30 days) of:

  * Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates), Unless recent use of prescription Opiates, Benzodiazepines for management of acute symptoms.
  * Experimental (investigational) drugs;
  * Psychiatric medications including antidepressants (selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), St. John's Wort), lithium, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
  * Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates, tramadol, or dopamine agonists;
  * Any agents that have documented correlation with increased incidence of valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone, nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) (or anticipated use during the study);
  * Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
  * Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
* Concurrent use of a serotonergic agent/combination associated with severe serotonin syndrome (within the past 30 days);
* Use of cigar, cigarillos, pipe, Hookah, dissolvable nicotine, snuff, chewing tobacco more than once per month.
* Use of e-cigarettes once per month or more.
* Self-report of consuming 4 or more alcoholic drinks on 1 or more days per week;
* Significant adverse reaction to lorcaserin or nicotine patch in the past.
* Current participation or recent participation (in the past 30 days) in another smoking study at the investigators Center or another research facility.
* Current participation in another research study.

Answer: B