Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: bupropion hydrochloride (Drug); nicotine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Richard D. Hurt, MD, Study Chair, Affiliation: Mayo Clinic
Summary
RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop
smoking and prevent them from starting smoking again. It is not yet known whether a nicotine
inhaler or bupropion are more effective alone or combined for stopping smoking.
PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or
bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to
stop smoking and prevent starting smoking again.
Clinical Details
Official title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Study design: Prevention
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
MBCCOP-Howard University Cancer Center, Washington, District of Columbia 20060, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas 67214, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Ochsner, New Orleans, Louisiana 70121, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
CentraCare Clinic, Saint Cloud, Minnesota 56303, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
Altru Health Systems, Grand Forks, North Dakota 58201, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Medcenter One Health System, Bismarck, North Dakota 58501, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States
CCOP - Sooner State, Tulsa, Oklahoma 74136, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2002
Last updated: May 23, 2008
|
