Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

PRIMARY OBJECTIVES:

I. To determine if varenicline plus a behavioral intervention consisting of a brief
clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical
complications through 24 weeks after surgery when compared to placebo plus the behavioral
intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.

SECONDARY OBJECTIVES:

I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality
of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention
(varenicline) and control group (placebo).

II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient
quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and
Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.

III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse
("Was It Worth It") each treatment (intervention versus [vs] control groups).

IV. To compare post-operative care (as measured by length of hospital and high dependency
unit stay) between the intervention and control groups.

V. To compare treatment adherence between the intervention and control groups. VI. To compare
rates of smoking abstinence between the intervention and control groups as a covariate of the
primary outcome only.

- Eligible patients will have a new diagnosis of lung cancer and have sought a surgical
consult relating to this diagnosis

- Surgery must be scheduled no sooner than 10 days after randomization and no more than
twelve weeks after randomization

- Have smoked daily or nearly every day in the previous 6 months up to the date of
surgical consult AND have smoked at least one puff in the previous 7 days

- Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation
Ladder

- Within the 30 days before registration, no use of: 1) any pharmacologic treatment for
smoking cessation, including bupropion or nicotine replacement therapy; 2) any
nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in
any formal behavioral treatment program for tobacco dependence as determined by
patient report

- No allergies to and not currently using varenicline

- No suicidal thoughts as indicated by a positive (1+) response to the PHQ9

- No active untreated clinically significant psychiatric condition (psychosis, bipolar
disorder, or depression)

- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
women of childbearing potential only

* A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
the preceding 12 consecutive months)

- No unstable angina, myocardial infarction, or coronary angioplasty within the past 3
months or an untreated cardiac dysrhythmia

- No history of seizures

- No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic
disease

- Not currently on renal dialysis or has a history of significant renal impairment

- No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by
National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:

- If male, drinking > 14 alcoholic beverages per week for past 1 month

- If female, drinking > 7 alcoholic beverages per week for past 1 month

- Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine
(MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid
diethylamide [LSD]) at any time during the past 1 month

- Use of marijuana on a weekly basis for the past 1 month

- Patients must be able to complete study questionnaires in English

- No other household member or relative participating in the study

- No known history of any condition or factor judged by the investigator to preclude
participation in the study or which might hinder study adherence

- Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated
creatinine clearance (CrCl) value