Please select the eligibility criteria that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: 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.
B: Inclusion Criteria:

* History of alcohol dependence and at least one year of abstinence from alcohol intake.
* Has a history of smoking 20 or more cigarettes per day for the prior year.
* Can read and write English.
* Stated ability to fully participate in the study and keep all scheduled appointments.
* Has provided written informed consent.
* General good health.

Exclusion Criteria:

* Recent history (within three months) of a clinically significant myocardial infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical condition which the physician investigator deems incompatible with study participation.
* Current major depression. A past history of major depression will not be an exclusionary criteria.
* Current or previous use of bupropion (Wellbutrin).
* Active non- nicotine drug dependence.
* Past or current history of bipolar disorder, pain disorder or psychosis, schizophrenia, or other major psychiatric disorders.
* Current medically indicated use of psychiatric drugs.
* Females who are pregnant, lactating, or likely to become pregnant during the first year which includes the nicotine patch and bupropion (Wellbutrin) phase.
* History of severe skin allergies or evidence of severe chronic skin disorders.
* Current use of nicotine containing medication or tobacco products other than cigarettes.
* Current use (within 30 days of initiation of patch therapy) of the following medications for smoking cessation: clonidine, buspirone, or doxepin.
* A predisposition to seizures.
* A history of or current diagnosis of anorexia nervosa or bulimia.
* Medical disorder that would interfere with the absorption, metabolism, or excretion of bupropion (Wellbutrin).
C: Inclusion Criteria:

* Self-identified African American
* Smokes ≥ 1 cigarette per day (cpd)
* Smoke on ≥ 25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month
* History of alcohol or drug dependence in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
* Evidence of current severe major depressive disorder or suicidal ideation
D: Inclusion Criteria:

* ≥ 18 years of age
* Smoke at least 10 cigarettes/day for the past year
* Suffered an enzyme-positive ACS
* Planned hospitalization of ≥24 hours
* Motivated to quit smoking
* Likely to be available for follow-up
* Able to understand and read English or French

Exclusion Criteria:

* Medical condition with a prognosis of \< 1 year
* Pregnant or lactating
* Current use of Wellbutrin or any other medications that contain bupropion
* Current use of any medical therapy for smoking cessation (e.g. BuSpar, fluoxetine, doxepin, nicotine gum, or nicotine patch)
* Current seizure disorder, history of seizures or predisposition to seizures (e.g. history of brain tumor, severe head trauma, or stroke)
* History of bulimia or anorexia nervosa
* Current diagnosis of major depression (requiring medication), bipolar disease, or dementia
* History of suicidal events (previous suicide attempt, suicidal ideation) or family history of suicide
* Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST or ALT levels ≥ 2 times upper limit of normal prior to admission for ACS)
* Renal impairment with creatinine levels ≥ 2 times the upper limit of normal
* Excessive alcohol consumption defined as ≥ 14 alcoholic drinks per week
* Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates)
* Current use of medications that lower seizure threshold e.g. amantadine, anti-depressants, anti-malarials, anti-psychotics, levodopa, lithium, quinolone antibiotics, ritonavir, systemic steroids, theophyllin, type 1C antiarrhythmics (e.g. encainide, flecainide, propafenone)
* Use of MAO inhibitors or thioridazine in the past 15 days
* Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or anoretics

Answer: A