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Smoking Cessation Study In Healthy Adolescent Smokers

12. července 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

312

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 19 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Lék: 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
Experimentální: 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
Lék: 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
Komparátor placeba: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Lék: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. dubna 2011

Primární dokončení (Aktuální)

1. ledna 2018

Dokončení studie (Aktuální)

1. ledna 2018

Termíny zápisu do studia

První předloženo

9. března 2011

První předloženo, které splnilo kritéria kontroly kvality

9. března 2011

První zveřejněno (Odhad)

11. března 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A3051073
  • CHANTIX (Jiný identifikátor: Alias Study Number)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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