Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Inclusion Criteria:

* Age 18-64
* Regular ten cigarette per day smoker for one year
* Nicotine Dependency Score greater than or equal to four
* DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
* Psychiatric medication regimen unchanged for at least 90 days
* Psychiatric medication dosage unchanged for at least 30 days

Exclusion Criteria:

* Psychiatric hospitalization in last 6 months
* Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
* Suicide or homicide ideation with a plan in the last six months
* Life time history of suicide attempt
* Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
* Current treatment with Bupropion SR
* DSM-IV diagnosis of alcohol or substance dependence within last 6 months\*
* DSM-IV diagnosis of alcohol or substance abuse within three months \*
* Pregnancy or lactation in females (+HCG)
* Use of tobacco product other than cigarettes
* Use of nicotine replacements
* Unstable or serious medical condition in last 6 months
* Regular use of cimetidine (OTC or Rx) \*Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
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:

* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

* Subjects with a past or current diagnosis of one of the following disorders:

  a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)
D: Inclusion Criteria:

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age \>35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

* Current smoking
* Suffering from COPD according to the GP's diagnosis
* In command of the Dutch language.

Exclusion Criteria:

* Too ill
* Under control of a chest physician
* Serious physical or psychological comorbidity

Answer: A