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

12 de julio de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1708

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: nicotina
Experimental: 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.
Droga: clorhidrato de bupropión
Experimental: 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.
Droga: nicotina
Experimental: Arm IV: bupropion

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

All participants are followed every month for 6 months.
Droga: clorhidrato de bupropión
Comparador de placebos: Arm V: placebo

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

All participants are followed every month for 6 months.
Otro: placebo
Experimental: 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.
Droga: nicotina
Comparador de placebos: 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.
Otro: placebo
Experimental: 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.
Droga: nicotina
Comparador de placebos: 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.
Otro: placebo
Experimental: Arm X: bupropion

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

All participants are followed every month for 6 months.
Droga: clorhidrato de bupropión
Comparador de placebos: Arm XI: placebo

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

All participants are followed every month for 6 months.
Otro: placebo
Experimental: 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.
Droga: nicotina
Comparador de placebos: 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.
Otro: placebo
Experimental: 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.
Droga: nicotina
Comparador de placebos: 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.
Otro: placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Prevention in relapse
Periodo de tiempo: Up to 6 months
Up to 6 months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Reduction in the rate of relapse
Periodo de tiempo: Up to 6 months
Up to 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Richard D. Hurt, MD, Mayo Clinic

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2002

Finalización primaria (Actual)

1 de julio de 2006

Finalización del estudio (Actual)

1 de julio de 2006

Fechas de registro del estudio

Enviado por primera vez

9 de abril de 2002

Primero enviado que cumplió con los criterios de control de calidad

5 de febrero de 2004

Publicado por primera vez (Estimar)

6 de febrero de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de julio de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

12 de julio de 2016

Última verificación

1 de julio de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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