Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
Lung Cancer
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Currently smoking at least 10 cigarettes per day Smoked regularly for the past year Motivated to use study medication More than 30 days since prior use of tobacco products other than cigarettes (e.g., smokeless tobacco, pipes, cigars, or snuff) No active chemical dependence of drug other than nicotine (e.g., alcohol, marijuana, cocaine, heroin, or other illicit drugs) within the past year PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable angina, myocardial infarction, or cardiac arrhythmias within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 3 months prior to and during study Good health by medical history No history of seizure disorder No epilepsy No prior serious head trauma or other predisposing factors to seizures (e.g., alcohol withdrawal, febrile seizures during childhood, brain tumor, cerebrovascular accident, or family history of idiopathic seizure disorder) No known hypersensitivity or allergy to nicotine, menthol, or bupropion No prior or concurrent diagnosis of bulimia or anorexia nervosa No other member of household currently enrolled on this study No bipolar disorder, psychosis, or schizophrenia PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: More than 30 days since prior systemic steroids Radiotherapy: Not specified Surgery: Not specified Other: More than 30 days since other prior behavioral or pharmacologic smoking- cessation program (e.g., behavioral therapy, nicotine replacement therapy, clonidine, bupropion, nortriptyline, or doxepin) More than 30 days since prior investigational drugs More than 30 days since prior antipsychotics or antidepressants More than 30 days since prior theophylline More than 30 days since prior monoamine oxidase inhibitor More than 30 days since prior medication containing bupropion No concurrent antiepileptic medications No concurrent medications known to lower seizure threshold No other concurrent investigational drugs
Sites / Locations
- CCOP - Scottsdale Oncology Program
- MBCCOP-Howard University Cancer Center
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- Cancer Center of Kansas - Wichita
- CCOP - Ochsner
- CCOP - Ann Arbor Regional
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Sooner State
- CCOP - Geisinger Clinic and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm I: nicotine inhaler cartridges
Arm II: bupropion
Arm III: nicotine inhaler cartridges
Arm IV: bupropion
Arm V: placebo
Arm VI: nicotine inhaler cartridges
Arm VII: placebo inhaler
Arm VIII: nicotine inhaler cartridges
Arm IX: placebo inhaler cartridges
Arm X: bupropion
Arm XI: placebo
Arm XII: nicotine inhaler cartridges
Arm XIII: placebo inhaler cartridges
Arm XIV: nicotine inhaler cartridges
Arm XV: placebo inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms Arm IV or Arm V. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms Arm VIII or Arm IX.
Participants receive oral bupropion 1-2 times daily. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms Arm VI or Arm VII. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms Arm Arm X or Arm XI.
Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms Arm XII, Arm XIII, Arm XIV or Arm XV.
Participants receive oral bupropion 1-2 times daily for 12 weeks. All participants are followed every month for 6 months.
Participants receive oral placebo 1-2 times daily for 12 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months.
Participants receive oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
Participants receive oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.
Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.