Strategies to Promote Smoking Cessation in Patients with Tobacco Related Malignancies

Inclusion Criteria

• Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies: * Lung or bronchus cancer or head & neck, cancers (all sites) * Esophagus, stomach, pancreas, kidney, urinary bladder, colon, rectum, cervix, vulvar, vaginal * Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy – except gynecologic patients undergoing ablative or local excisional therapies (laser ablation, cervical conization, LEEP)
• Having smoked at least 1 cigarette within 4 weeks of study enrollment
• Having at least a 10-pack year history of cigarette smoking
• Having smoked at least one cigarette within 1 month of cancer diagnosis
• Life expectancy is greater than 1 year
• Patient has an Alcohol Use & Dependence (AUDIT) score of < 10
• Patient has Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Patients must have the ability to understand and the willingness to provide signed written informed consent document

Exclusion Criteria

• Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine
• History of suicide attempt or preparation for attempt within the past 10 years
• Columbia Suicide Severity Rating Scale (C-SRSS) baseline/screening: * Patient response of “Yes” to any question in column two (past 6 months and past 10 years), except question 1 * Patient response of “Yes” to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation
• Hospitalized for psychiatric illness within the past two years
• History of bipolar disorder
• Currently taking bupropion (bupropion hydrochloride) for depression
• Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks
• History of eating disorder such as anorexia or bulimia
• Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
• History of epilepsy or seizure disorder
• Active severe kidney or liver disease
• Women must not be pregnant or lactating; women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use an effective method to avoid pregnancy during and for 30 days following last cessation drug dose
• Patients within three months of a myocardial infarction
• Patients with unstable angina or serious arrhythmia
• Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake
• Patient taking varenicline or bupropion within one month of study enrollment
• Participation in any other investigational drug study within 4 weeks of study enrollment
• Currently enrolled in other professional tobacco cessation therapeutic intervention
• Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site principal investigator (PI) to determine that there are no drug interactions concerns