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Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention


OBJECTIVES: I. Compare the effectiveness of nicotine inhaler vs bupropion vs nicotine
inhaler plus bupropion on smoking cessation and prevention of relapse in participants who
currently smoke. II. Compare the reduction in the rate of relapse to smoking after initial
abstinence in participants treated long term with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to gender, cigarettes smoked per day at time of screening (10-39 vs
40 or more), and total length of smoking in years (less than 5 vs 5-9 vs 10 or more).
Participants are randomized to one of three treatment arms. Arm I: Participants receive 6-16
nicotine inhaler cartridges per day. Arm II: Participants receive oral bupropion 1-2 times
daily. Arm III: Participants receive 6-16 nicotine inhaler cartridges per day and oral
bupropion 1-2 times daily. In all arms, 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: Participants receive oral bupropion 1-2 times daily for 12 weeks
Arm V: Participants receive oral placebo 1-2 times daily for 12 weeks. Participants
randomized to arm II who continue to smoke are randomized to one of two treatment arms. Arm
VI: Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. Arm VII:
Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. Participants
randomized to arm III who continue to smoke do not receive any further therapy. Participants
randomized to arm I who are smoke-free are randomized to one of two treatment arms. Arm
VIII: Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. Arm IX:
Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. Participants
randomized to arm II who are smoke-free are randomized to one of two treatment arms. Arm X:
Participants receive oral bupropion 1-2 times daily for 40 weeks. Arm XI: Participants
receive oral placebo 1-2 times daily for 40 weeks. Participants randomized to arm III who
are smoke-free are randomized to one of four treatment arms. Arm XII: Participants receive
6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. Arm
XIII: Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2
times daily for 40 weeks. Arm XIV: Participants receive 6-16 nicotine inhaler cartridges per
day and oral bupropion 1-2 times daily for 40 weeks. Arm XV: 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.

PROJECTED ACCRUAL: Approximately 1850 participants (616 per treatment arm of the initial
randomization) will be accrued for this study within 6 months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Richard D. Hurt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069303

NCT ID:

NCT00033592

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms
  • Smoking

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Sooner StateTulsa, Oklahoma  74136
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060
Medcenter One Health SystemBismarck, North Dakota  58501
Cancer Center of Kansas - WichitaWichita, Kansas  67214