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Smoking Cessation Study In Healthy Adolescent Smokers

2018年7月12日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

312

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 19年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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
药品：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
实验性的：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
药品：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
安慰剂比较：Placebo
Oral placebo for twelve weeks,follow-up through Week 52
药品：Placebo
Oral placebo for twelve weeks,follow-up through Week 52

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With Treatment-Emergent Adverse Events (AEs)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年4月1日

初级完成 (实际的)

2018年1月1日

研究完成 (实际的)

2018年1月1日

研究注册日期

首次提交

2011年3月9日

首先提交符合 QC 标准的

2011年3月9日

首次发布 (估计)

2011年3月11日

研究记录更新

最后更新发布 (实际的)

2018年8月9日

上次提交的符合 QC 标准的更新

2018年7月12日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A3051073
  • CHANTIX (其他标识符：Alias Study Number)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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