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Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke Clinical research trials and Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke  Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
For Condition: prevention of lung cancer,Non-small cell lung cancer,Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: Patient Abstract available in the near future.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardHurt, Study Chair, North Central Cancer Treatment Group
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Additional Information:
Study ID Numbers: CDR0000069303; NCCTG-N99C4,NCI-P02-0220
Study Start Date: February 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033592
Other Non-Small Cell Lung Cancer Studies:
1. Oltipraz in the Prevention of Lung Cancer in People Who Smoke
2. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Iowa Clinical Trials
Other Sioux City Clinical Trials
Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
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