Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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Arizona
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Scottsdale, Arizona, Yhdysvallat, 85259-5404
- CCOP - Scottsdale Oncology Program
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District of Columbia
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Washington, District of Columbia, Yhdysvallat, 20060
- MBCCOP-Howard University Cancer Center
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Illinois
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Peoria, Illinois, Yhdysvallat, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Yhdysvallat, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Yhdysvallat, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Yhdysvallat, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Yhdysvallat, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Yhdysvallat, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, Yhdysvallat, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70121
- CCOP - Ochsner
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, Yhdysvallat, 55805
- CCOP - Duluth
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Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Yhdysvallat, 56303
- CentraCare Clinic
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Saint Louis Park, Minnesota, Yhdysvallat, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Yhdysvallat, 58501
- Medcenter One Health System
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Fargo, North Dakota, Yhdysvallat, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Yhdysvallat, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, Yhdysvallat, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Tulsa, Oklahoma, Yhdysvallat, 74136
- CCOP - Sooner State
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Pennsylvania
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Danville, Pennsylvania, Yhdysvallat, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, Yhdysvallat, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Yhdysvallat, 57104
- CCOP - Sioux Community Cancer Consortium
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Arm I: nicotine 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. |
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Kokeellinen: Arm II: bupropion
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. |
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Kokeellinen: Arm III: nicotine inhaler cartridges
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. |
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Kokeellinen: Arm IV: bupropion
Participants receive oral bupropion 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
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Placebo Comparator: Arm V: placebo
Participants receive oral placebo 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
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Kokeellinen: Arm VI: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months. |
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Placebo Comparator: Arm VII: placebo inhaler
Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months. |
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Kokeellinen: Arm VIII: nicotine inhaler cartridges
Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months. |
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Placebo Comparator: Arm IX: placebo inhaler cartridges
Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months. |
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Kokeellinen: Arm X: bupropion
Participants receive oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
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Placebo Comparator: Arm XI: placebo
Participants receive oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
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Kokeellinen: Arm XII: nicotine inhaler cartridges
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. |
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Placebo Comparator: Arm XIII: placebo inhaler cartridges
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. |
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Kokeellinen: Arm XIV: nicotine inhaler cartridges
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. |
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Placebo Comparator: Arm XV: placebo inhaler cartridges
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Prevention in relapse
Aikaikkuna: Up to 6 months
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Up to 6 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Reduction in the rate of relapse
Aikaikkuna: Up to 6 months
|
Up to 6 months
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Richard D. Hurt, MD, Mayo Clinic
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Neoplasmat
- Keuhkosairaudet
- Neoplasmat sivustoittain
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Keuhkojen kasvaimet
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Autonomiset agentit
- Ääreishermoston aineet
- Kolinergiset aineet
- Entsyymin estäjät
- Psykotrooppiset lääkkeet
- Neurotransmitterien sisäänoton estäjät
- Kalvon kuljetusmodulaattorit
- Masennuslääkkeet
- Dopamiini-aineet
- Sytokromi P-450 -entsyymin estäjät
- Ganglioniset stimulantit
- Nikotiiniagonistit
- Kolinergiset agonistit
- Toisen sukupolven masennuslääkkeet
- Sytokromi P-450 CYP2D6:n estäjät
- Dopamiinin sisäänoton estäjät
- Nikotiini
- Bupropion
Muut tutkimustunnusnumerot
- NCCTG-N99C4
- CDR0000069303 (Rekisterin tunniste: PDQ (Physician Data Query))
- NCI-P02-0220
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