Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT01532232
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01532232
Study Brief:
Protocol Section:
NCT01532232