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Smoking Cessation Study In Healthy Adolescent Smokers

12. juli 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

312

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: 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
Eksperimentel: 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
Medicin: 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
Placebo komparator: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Medicin: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2011

Primær færdiggørelse (Faktiske)

1. januar 2018

Studieafslutning (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først indsendt

9. marts 2011

Først indsendt, der opfyldte QC-kriterier

9. marts 2011

Først opslået (Skøn)

11. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A3051073
  • CHANTIX (Anden identifikator: Alias Study Number)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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