Please select the eligibility criteria that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Inclusion Criteria:

* currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
* 18 years or older
* interested in quitting within the next 30 days
* one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)

Exclusion Criteria:

* contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
* current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
* unable to give consent
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:

* 14 to 17 years of age
* Smoked at least 6 cigarettes per day
* Exhaled CO greater than or equal to 10 ppm
* Made at least two previous quit attempts
* Weighed at least 90 pounds
* Able to read English at least the 6th grade level
* Motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study
* provided active parental consent and youth assent

Exclusion Criteria:

* Current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration
* Current use of other treatments for smoking cessation
* History or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder
* History of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study
* Current evidence of clinical depression or Attention Deficit/Hyperactivity Disorder
* Use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study
* Predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures
* Significant history of or current clinical evidence of cardiovascular disease
* (Females)Pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study
* Only one member of a household was allowed to participate in the study concurrently.
D: smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Answer: A