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Smoking Cessation Study In Healthy Adolescent Smokers

12 июля 2018 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

312

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 12 лет до 19 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Лекарство: 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
Экспериментальный: 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
Лекарство: 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
Плацебо Компаратор: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Лекарство: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 апреля 2011 г.

Первичное завершение (Действительный)

1 января 2018 г.

Завершение исследования (Действительный)

1 января 2018 г.

Даты регистрации исследования

Первый отправленный

9 марта 2011 г.

Впервые представлено, что соответствует критериям контроля качества

9 марта 2011 г.

Первый опубликованный (Оценивать)

11 марта 2011 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 августа 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

12 июля 2018 г.

Последняя проверка

1 июля 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • A3051073
  • CHANTIX (Другой идентификатор: Alias Study Number)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Varenicline 1mg BID

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