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Smoking Cessation Study In Healthy Adolescent Smokers

12 juli 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

312

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 19 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: 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
Experimentell: 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
Läkemedel: 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-jämförare: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Läkemedel: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2011

Primärt slutförande (Faktisk)

1 januari 2018

Avslutad studie (Faktisk)

1 januari 2018

Studieregistreringsdatum

Först inskickad

9 mars 2011

Först inskickad som uppfyllde QC-kriterierna

9 mars 2011

Första postat (Uppskatta)

11 mars 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juli 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A3051073
  • CHANTIX (Annan identifierare: Alias Study Number)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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