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Smoking Cessation Study In Healthy Adolescent Smokers

12 de julio de 2018 actualizado por: Pfizer

A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

312

Fase

  • Fase 4

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
    • Ontario
      • Ajax, Ontario, Canadá, L1Z 0M1
        • Kids Clinic
      • New Market, Ontario, Canadá, L3Y 5G8
        • SKDS Research Inc.
      • Newmarket, Ontario, Canadá, L3Y 5G8
        • Private Practice of Robert J. Camargo
  • Corea, república de
      • Daegu, Corea, república de, 41931
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Corea, república de, 14068
        • Hallym University Sacred Heart Hospital
      • Seongnam-si, Gyeonggi-do, Corea, república de, 13620
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Corea, república de, 442 723
        • The Catholic University of Korea St. Vincent Hospital
  • Estados Unidos
    • Alabama
      • Ozark, Alabama, Estados Unidos, 36360
        • IICR, Inc. (DBA: International Institute of Clinical Research)
    • Arizona
      • Goodyear, Arizona, Estados Unidos, 85395
        • Dedicated Clinical Research
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72211
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
    • California
      • Anaheim, California, Estados Unidos, 92801
        • Anaheim Clinical Trials, LLC
      • La Habra, California, Estados Unidos, 90631
        • Omega Clinical Trials, LLC
      • National City, California, Estados Unidos, 91950
        • Synergy Clinical Research Center
      • Oakland, California, Estados Unidos, 94607
        • Pacific Research Partners, LLC
      • Oceanside, California, Estados Unidos, 92054
        • North County Clinical Research
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Anschutz Medical Campus
      • Colorado Springs, Colorado, Estados Unidos, 80910
        • MCB Clinical Research Centers
      • Denver, Colorado, Estados Unidos, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale University
      • New Haven, Connecticut, Estados Unidos, 06511
        • Connecticut Mental Health Center
      • New Haven, Connecticut, Estados Unidos, 06511
        • Yale University, SATU
    • Florida
      • DeLand, Florida, Estados Unidos, 32720
        • Avail Clinical Research, LLC
      • Kissimmee, Florida, Estados Unidos, 34741
        • HOPE Clinical Research
      • Maitland, Florida, Estados Unidos, 32751
        • Florida Clinical Research Center, LLC
      • Miami, Florida, Estados Unidos, 33126
        • Pharmax Research Clinic, Inc.
      • Miami, Florida, Estados Unidos, 33144
        • L & L Research Choices
      • North Bay Village, Florida, Estados Unidos, 33141
        • Bravo Health Care Center
      • Orange City, Florida, Estados Unidos, 32763
        • Medical Research Group of Central Florida
      • Saint Petersburg, Florida, Estados Unidos, 33716
        • Comprehensive Clinical Development Inc.
    • Idaho
      • Meridian, Idaho, Estados Unidos, 83646
        • Solaris Clinical Research
      • Meridian, Idaho, Estados Unidos, 83646
        • Barney Greenspan, Ph.D
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47715
        • Midwest Behavioral Health
      • Indianapolis, Indiana, Estados Unidos, 46260
        • Goldpoint Clinical Research, LLC
      • Newburgh, Indiana, Estados Unidos, 47630
        • Pedia Research, LLC
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, Estados Unidos, 40509
        • Central Kentucky Research Associates, Inc.
      • Owensboro, Kentucky, Estados Unidos, 42301
        • Pedia Research, LLC
      • Owensboro, Kentucky, Estados Unidos, 42303
        • Research Integrity, LLC
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70114
        • Louisiana Research Associates, Inc
    • Massachusetts
      • Watertown, Massachusetts, Estados Unidos, 02472
        • Adams Clinical Trials, LLC
    • Michigan
      • Rochester Hills, Michigan, Estados Unidos, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64114
        • The Center for Pharmaceutical Research, P.C.
      • O'Fallon, Missouri, Estados Unidos, 63368
        • Psychiatric Care & Research Center
      • Saint Louis, Missouri, Estados Unidos, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68526
        • Premier Psychiatric Research Institute, LLC
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, Estados Unidos, 27612
        • Wake Internal Medicine Consultants, Inc
      • Wilmington, North Carolina, Estados Unidos, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Toledo, Ohio, Estados Unidos, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
        • Cutting Edge Research Group
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
      • Mount Pleasant, South Carolina, Estados Unidos, 29464
        • Coastal Carolina Research Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
        • FutureSearch Trials of Dallas, L.P.
      • DeSoto, Texas, Estados Unidos, 75115
        • InSite Clinical Research, LLC
      • Lake Jackson, Texas, Estados Unidos, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, Estados Unidos, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, Estados Unidos, 78230
        • Thomas Murray DeMoor, MD
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Kirkland, Washington, Estados Unidos, 98033
        • Eastside Therapeutic Resource
      • Richland, Washington, Estados Unidos, 99352
        • Zain Research, Llc
    • Wisconsin
      • Middleton, Wisconsin, Estados Unidos, 53562
        • Dean Foundation for Health Research and Education
  • Federación Rusa
      • Moscow, Federación Rusa, 119331
        • GBUZ City childrens out-patient clinic # 10 of Moscow
      • Murmansk, Federación Rusa, 183036
        • GOBUZ Murmansk Regional Narcology Dispensary
      • Novosibirsk, Federación Rusa, 630091
        • LLC City Neurological Center "Sibneuromed"
      • Saint-Petersburg, Federación Rusa, 190068
        • LLC " Alliance Biomedical - Russian Group"
      • Saint-Petersburg, Federación Rusa, 191025
        • LLC Medical Technologies
      • Saint-Petersburg, Federación Rusa, 192019
        • FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
      • Saint-Petersburg, Federación Rusa, 192148
        • LLC Medical Technologies
      • Saint-Petersburg, Federación Rusa, 197022
        • First St. Petersburg State Medical University
      • Samara, Federación Rusa, 443031
        • GBUZ Samara Regional Childrens Health camp Yunost
    • Leningrad Region
      • Village Novoe Devyatkino, Leningrad Region, Federación Rusa, 188661
        • Leningrad Regional Dispensary of Narcology
  • Georgia
      • Rustavi, Georgia, 3700
        • LTD" Rustavi Psychological Health Center"
  • Taiwán
      • Kaohsiung City, Taiwán, 81362
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taiwán, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwán, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung city, Taiwán, 40447
        • China Medical University Hospital
      • Tainan, Taiwán, 704
        • National Cheng Kung University Hospital
      • Taipei City, Taiwán, 11217
        • Taipei Veterans General Hospital

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

12 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 12 and 19, inclusive.
  • Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
  • Subjects must have at least one prior failed attempt to quit smoking.

Exclusion Criteria:

  • Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
  • Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
  • Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Droga: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Experimental: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Droga: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Comparador de placebos: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Droga: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Periodo de tiempo: Week 9 through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
Week 9 through Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Periodo de tiempo: Weeks 12, 24 and 52
The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
Periodo de tiempo: Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
Periodo de tiempo: Baseline, Weeks 12, 24, and 52
The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
Periodo de tiempo: Week 9 through Week 24; Week 9 through Week 52
The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
Week 9 through Week 24; Week 9 through Week 52

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Periodo de tiempo: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Periodo de tiempo: First dose up to last dose (up-to Week 12) plus 30 days
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
Periodo de tiempo: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("Yes" on "wish to be dead","non-specific active suicidal thoughts","active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.
Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
Periodo de tiempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
Periodo de tiempo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Number of Participants With Laboratory Abnormalities
Periodo de tiempo: Baseline up to Week 12
Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.
Baseline up to Week 12
Change From Baseline in Blood Pressure (BP) at Week 12
Periodo de tiempo: Baseline, Week 12
Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.
Baseline, Week 12
Change From Baseline in Pulse Rate at Week 12
Periodo de tiempo: Baseline, Week 12
Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.
Baseline, Week 12

Colaboradores e Investigadores

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

Patrocinador

Pfizer

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 (Actual)

1 de abril de 2011

Finalización primaria (Actual)

1 de enero de 2018

Finalización del estudio (Actual)

1 de enero de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

9 de marzo de 2011

Publicado por primera vez (Estimar)

11 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de agosto de 2018

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

12 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A3051073
  • CHANTIX (Otro identificador: Alias Study Number)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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