이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Smoking Cessation Study In Healthy Adolescent Smokers

2018년 7월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

312

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: 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
실험적: 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
의약품: 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
위약 비교기: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
의약품: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-Emergent Adverse Events (AEs)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 4월 1일

기본 완료 (실제)

2018년 1월 1일

연구 완료 (실제)

2018년 1월 1일

연구 등록 날짜

최초 제출

2011년 3월 9일

QC 기준을 충족하는 최초 제출

2011년 3월 9일

처음 게시됨 (추정)

2011년 3월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 12일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A3051073
  • CHANTIX (기타 식별자: Alias Study Number)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Varenicline 1mg BID에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Suriname

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다