- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00033592
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
-
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20060
- MBCCOP-Howard University Cancer Center
-
-
Illinois
-
Peoria, Illinois, Forente stater, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, Forente stater, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, Forente stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, Forente stater, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, Forente stater, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Forente stater, 67214-3882
- CCOP - Wichita
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70121
- CCOP - Ochsner
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Ann Arbor Regional
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic
-
Saint Louis Park, Minnesota, Forente stater, 55416
- CCOP - Metro-Minnesota
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68131
- CCOP - Missouri Valley Cancer Consortium
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Health System
-
Fargo, North Dakota, Forente stater, 58122
- CCOP - Merit Care Hospital
-
Grand Forks, North Dakota, Forente stater, 58201
- Altru Health Systems
-
-
Ohio
-
Toledo, Ohio, Forente stater, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- CCOP - Sooner State
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forente stater, 57104
- CCOP - Sioux Community Cancer Consortium
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: Arm IV: bupropion
Participants receive oral bupropion 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
|
Placebo komparator: Arm V: placebo
Participants receive oral placebo 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
|
Eksperimentell: Arm X: bupropion
Participants receive oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
|
Placebo komparator: Arm XI: placebo
Participants receive oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Prevention in relapse
Tidsramme: Up to 6 months
|
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reduction in the rate of relapse
Tidsramme: Up to 6 months
|
Up to 6 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Richard D. Hurt, MD, Mayo Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Enzymhemmere
- Psykotropiske stoffer
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhemmere
- Ganglioniske stimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, andre generasjon
- Cytokrom P-450 CYP2D6-hemmere
- Dopaminopptakshemmere
- Nikotin
- Bupropion
Andre studie-ID-numre
- NCCTG-N99C4
- CDR0000069303 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-P02-0220
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungekreft
-
Yonsei UniversityFullført
-
Novartis PharmaceuticalsFullførtNevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung OriginForente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
-
The Cleveland ClinicTilbaketrukketOne Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
-
Assiut UniversityHar ikke rekruttert ennåLungekreft | Lungeskade | Bleb Lung
-
RenJi HospitalRekrutteringMultiple Synchronous Lung Cancers (MSLC)Kina
-
Poitiers University HospitalFullførtEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
-
University of LorraineFullførtBare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb LungFrankrike
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Damascus UniversityUniversity Children's HospitalFullførtEsophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; AbscessDen syriske arabiske republikk
-
Ministry of Health, Saudi ArabiaHar ikke rekruttert ennåLuftveissykdom | Prematuritet | Ventilator Lung; Nyfødt
Kliniske studier på placebo
-
SamA Pharmaceutical Co., LtdUkjentAkutt bronkitt | Akutt øvre luftveisinfeksjonKorea, Republikken
-
National Institute on Drug Abuse (NIDA)FullførtCannabisbrukForente stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyFullførtMannlige personer med type II diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedFullførtFarmakokinetikk | SikkerhetsproblemerStorbritannia
-
Regado Biosciences, Inc.FullførtFrivillig friskForente stater
-
Texas A&M UniversityNutraboltFullførtGlucose and Insulin Response
-
Longeveron Inc.AvsluttetHypoplastisk venstre hjertesyndromForente stater
-
ItalfarmacoFullførtBecker muskeldystrofiNederland, Italia
-
Instituto de Investigación Hospital Universitario...Creaciones Aromáticas Industriales, S.A. (CARINSA)Fullført