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Smoking Cessation Study In Healthy Adolescent Smokers

12. Juli 2018 aktualisiert von: 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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Tatsächlich)

312

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 19 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
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
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
Placebo-Komparator: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Oral placebo for twelve weeks,follow-up through Week 52

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2011

Primärer Abschluss (Tatsächlich)

1. Januar 2018

Studienabschluss (Tatsächlich)

1. Januar 2018

Studienanmeldedaten

Zuerst eingereicht

9. März 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. März 2011

Zuerst gepostet (Schätzen)

11. März 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juli 2018

Zuletzt verifiziert

1. Juli 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • A3051073
  • CHANTIX (Andere Kennung: Alias Study Number)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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