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Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

12 juillet 2016 mis à jour par: Alliance for Clinical Trials in Oncology

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1708

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • États-Unis
    • Arizona
      • Scottsdale, Arizona, États-Unis, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • District of Columbia
      • Washington, District of Columbia, États-Unis, 20060
        • MBCCOP-Howard University Cancer Center
    • Illinois
      • Peoria, Illinois, États-Unis, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, États-Unis, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, États-Unis, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, États-Unis, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, États-Unis, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, États-Unis, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, États-Unis, 67214-3882
        • CCOP - Wichita
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70121
        • CCOP - Ochsner
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Duluth, Minnesota, États-Unis, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, États-Unis, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, États-Unis, 56303
        • CentraCare Clinic
      • Saint Louis Park, Minnesota, États-Unis, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, États-Unis, 58501
        • Medcenter One Health System
      • Fargo, North Dakota, États-Unis, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, États-Unis, 58201
        • Altru Health Systems
    • Ohio
      • Toledo, Ohio, États-Unis, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Oklahoma
      • Tulsa, Oklahoma, États-Unis, 74136
        • CCOP - Sooner State
    • Pennsylvania
      • Danville, Pennsylvania, États-Unis, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Rapid City, South Dakota, États-Unis, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, États-Unis, 57104
        • CCOP - Sioux Community Cancer Consortium

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: nicotine
Expérimental: 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.
Médicament: chlorhydrate de bupropion
Expérimental: 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.
Médicament: nicotine
Expérimental: Arm IV: bupropion

Participants receive oral bupropion 1-2 times daily for 12 weeks.

All participants are followed every month for 6 months.
Médicament: chlorhydrate de bupropion
Comparateur placebo: Arm V: placebo

Participants receive oral placebo 1-2 times daily for 12 weeks.

All participants are followed every month for 6 months.
Autre: placebo
Expérimental: 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.
Médicament: nicotine
Comparateur placebo: 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.
Autre: placebo
Expérimental: 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.
Médicament: nicotine
Comparateur placebo: 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.
Autre: placebo
Expérimental: Arm X: bupropion

Participants receive oral bupropion 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Médicament: chlorhydrate de bupropion
Comparateur placebo: Arm XI: placebo

Participants receive oral placebo 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Autre: placebo
Expérimental: 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.
Médicament: nicotine
Comparateur placebo: 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.
Autre: placebo
Expérimental: 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.
Médicament: nicotine
Comparateur placebo: 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.
Autre: placebo

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Prevention in relapse
Délai: Up to 6 months
Up to 6 months

Mesures de résultats secondaires

Mesure des résultats
Délai
Reduction in the rate of relapse
Délai: Up to 6 months
Up to 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Alliance for Clinical Trials in Oncology

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chaise d'étude: Richard D. Hurt, MD, Mayo Clinic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2002

Achèvement primaire (Réel)

1 juillet 2006

Achèvement de l'étude (Réel)

1 juillet 2006

Dates d'inscription aux études

Première soumission

9 avril 2002

Première soumission répondant aux critères de contrôle qualité

5 février 2004

Première publication (Estimation)

6 février 2004

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2016

Dernière vérification

1 juillet 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCCTG-N99C4
  • CDR0000069303 (Identificateur de registre: PDQ (Physician Data Query))
  • NCI-P02-0220

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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