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Smoking Cessation Study In Healthy Adolescent Smokers

12. juli 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

312

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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
Eksperimentell: 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
Legemiddel: 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
Legemiddel: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2011

Primær fullføring (Faktiske)

1. januar 2018

Studiet fullført (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først innsendt

9. mars 2011

Først innsendt som oppfylte QC-kriteriene

9. mars 2011

Først lagt ut (Anslag)

11. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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