Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Smoking Cessation Study In Healthy Adolescent Smokers

12 luglio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

312

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 19 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: 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
Sperimentale: 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
Droga: 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
Comparatore placebo: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Droga: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2011

Completamento primario (Effettivo)

1 gennaio 2018

Completamento dello studio (Effettivo)

1 gennaio 2018

Date di iscrizione allo studio

Primo inviato

9 marzo 2011

Primo inviato che soddisfa i criteri di controllo qualità

9 marzo 2011

Primo Inserito (Stima)

11 marzo 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2018

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A3051073
  • CHANTIX (Altro identificatore: Alias Study Number)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Varenicline 1mg BID

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Australia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi