Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Condition: Lung Carcinoma
MeSH terms: Lung Neoplasms
Intervention: Varenicline; Placebo; Tobacco Cessation Counseling
Intervention description: Given PO; Given PO; Complete counseling session
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well management of a tobacco treatment
      intervention works in reducing surgical complications in patients with newly diagnosed lung
      cancer who smoke cigarettes. Management of a tobacco treatment intervention compares
      varenicline (a drug that reduces the craving and withdrawal symptoms that occur with
      abstinence from nicotine) and behavioral interventions (consisting of a brief
      clinician-delivered intervention and tobacco quitline [tobacco cessation service available
      through a toll-free telephone number] follow-up) with placebo (a pill with no active
      medication) along with similar behavioral interventions. It is not yet known whether
      management of a tobacco treatment intervention is more effective in reducing surgical
      complications than placebo.
    

Eligibility criteria:

        -  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