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Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

2 de mayo de 2018 actualizado por: Michael Stein, MD, Butler Hospital

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.

Secondary

  • To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
  • To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.

OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

  • Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.

Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

315

Fase

  • No aplica

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

  • Estados Unidos
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Rhode Island Hospital Comprehensive Cancer Center

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 a 120 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

INCLUSION CRITERIA

  • Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

  • Interested in quitting smoking

    • Willing to set a quit date 7 days after baseline assessment

  • Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

    • Codac, Inc. (with two independent sites)
    • Addiction Recovery Institute
    • Center for Treatment and Recovery
    • Discovery House
  • Has received methadone for at least the past month

EXCLUSION CRITERIA

  • Pregnant or nursing (Must have negative pregnancy test)
  • Non-English speaking
  • No personal telephone or does not live close to a relative or neighbor with a telephone
  • Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
  • Unvailable for this study for the next 12 months
  • Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
  • Active skin condition (e.g., psoriasis)
  • History of skin allergy
  • History of a suicide attempt
  • Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent insulin or blood thinners
  • No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

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 paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
Droga: varenicline
Given orally
Comparador de placebos: Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
Otro: placebo
Administrado oralmente
Comparador activo: Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
Droga: nicotine
Given transdermally and orally

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self- Reported 7-day Abstinence
Periodo de tiempo: 6 Months
Number of participants with self-reported, 7-day abstinence at 6-months
6 Months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Periodo de tiempo: 6-Months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
6-Months
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Periodo de tiempo: 6-Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
6-Months
Self-reported 7-day Abstinence
Periodo de tiempo: 12 Months
Number of participants with self-reported 7-day abstinence at 12-months
12 Months
CO-confirmed 7-day Abstinence
Periodo de tiempo: 12 Months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
12 Months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Smoking Urges
Periodo de tiempo: 6 months
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Withdrawal Symptoms
Periodo de tiempo: 6 months
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Retention in Methadone Maintenance
Periodo de tiempo: 12 months
12 months
Methadone Dose Changes
Periodo de tiempo: 12 months
12 months
Use of Illicit Drugs as Measured by Urine Toxicologies
Periodo de tiempo: 12 months
12 months
Reinforcing Effects of Smoking
Periodo de tiempo: 6 months
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Change in Cigarettes Per Day
Periodo de tiempo: 6-Months
Change in mean cigarettes per day
6-Months

Colaboradores e Investigadores

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

Patrocinador

Butler Hospital

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Michael Stein, MD, Butler Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 septiembre de 2008

Finalización primaria (Actual)

1 de octubre de 2012

Finalización del estudio (Actual)

1 de octubre de 2012

Fechas de registro del estudio

Enviado por primera vez

11 de noviembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2008

Publicado por primera vez (Estimar)

13 de noviembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de junio de 2018

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

2 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000616663
  • R01CA129226 (Subvención/contrato del NIH de EE. UU.)
  • BUTLER-0807-004

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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