Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)
Brief Summary: Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.


Options:
A: Inclusion Criteria:

* MSK patients diagnosed with breast cancer or have a mass suspicious of breast cancer at the time of enrollment, as per clinician judgment or EMR;
* Self-reported current cigarette smoker (defined as daily smoking in the past seven days)
* Advised to quit smoking by their MSK physician and willing to receive smoking cessation counseling and treatment; as per self report
* Fluent in English

Exclusion Criteria:

* Patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
* Evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (New York Heart Association class III or IV), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
* Self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
* Self-reported evidence of recent substance abuse or heavy alcohol use (\> 14 drinks weekly) in the last 6 months;
* Self-reported recent use (in the past 30 days) or planned use of nicotine replacement therapy (NRT) or other FDA approved cessation pharmacotherapy (bupropion);
* Pre-menopausal women who are pregnant as per EMR
* Women who are breast-feeding as per self-report.
B: Inclusion Criteria:

* males and females
* over age 18
* used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
* residing within 100km of New Dehli for the next 4 months
* interested in quitting use of smokeless tobacco.

Exclusion Criteria:

* currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
* plan to use other smoking cessation treatments in the next 4 months
* smoke cigarettes
* have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
* have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
* Current use or discontinuation within last 14 days of:

  1. smoking cessation medications (bupropion, Varenicline, NRT);
  2. antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
  3. Anti-coagulants;
  4. Daily medication for asthma or diabetes (eligible with physician approval);
* are pregnant, planning a pregnancy, or lactating
* have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
* have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
* have an allergy to Varenicline
* ever contemplated or attempted suicide
* have serious/unstable disease within the past 6 months (e.g., cancer \[but melanoma\], heart disease, HIV/AIDS)
* have a history of epilepsy or seizure disorder
* have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (\>100 beats/minute)
* have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP\>150 or DBP\>90)16)
* have a history of kidney or liver failure
* have any medical condition or medication that could compromise safety as determined by a study physician
* cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
C: Inclusion Criteria:

* Smoking 35 or more cigarettes per week or 5 or more cigarettes per day,
* Smoking for at least 2 years, with no period of abstinence longer than 3 months.

Exclusion Criteria:

* Using any smoking cessation drugs or nicotine replacement drugs in the last 3 months,
* Use of medication to treat depression or any psychiatric illness,
* Impaired renal function,
* Unstable medical condition,
* Pregnancy or breast feeding.
D: Inclusion Criteria:

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

Exclusion Criteria:

prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is \>20

Answer: A