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Smoking Cessation Study In Healthy Adolescent Smokers

12 juillet 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

312

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • 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
  • Corée, République de
      • Daegu, Corée, République de, 41931
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Corée, République de, 14068
        • Hallym University Sacred Heart Hospital
      • Seongnam-si, Gyeonggi-do, Corée, République de, 13620
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Corée, République de, 442 723
        • The Catholic University Of Korea St. Vincent Hospital
  • Fédération Russe
      • Moscow, Fédération Russe, 119331
        • GBUZ City childrens out-patient clinic # 10 of Moscow
      • Murmansk, Fédération Russe, 183036
        • GOBUZ Murmansk Regional Narcology Dispensary
      • Novosibirsk, Fédération Russe, 630091
        • LLC City Neurological Center "Sibneuromed"
      • Saint-Petersburg, Fédération Russe, 190068
        • LLC " Alliance Biomedical - Russian Group"
      • Saint-Petersburg, Fédération Russe, 191025
        • LLC Medical Technologies
      • Saint-Petersburg, Fédération Russe, 192019
        • FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
      • Saint-Petersburg, Fédération Russe, 192148
        • LLC Medical Technologies
      • Saint-Petersburg, Fédération Russe, 197022
        • First St. Petersburg State Medical University
      • Samara, Fédération Russe, 443031
        • GBUZ Samara Regional Childrens Health camp Yunost
    • Leningrad Region
      • Village Novoe Devyatkino, Leningrad Region, Fédération Russe, 188661
        • Leningrad Regional Dispensary of Narcology
  • Géorgie
      • Rustavi, Géorgie, 3700
        • LTD" Rustavi Psychological Health Center"
  • Taïwan
      • Kaohsiung City, Taïwan, 81362
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taïwan, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taïwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung city, Taïwan, 40447
        • China Medical University Hospital
      • Tainan, Taïwan, 704
        • National Cheng Kung University Hospital
      • Taipei City, Taïwan, 11217
        • Taipei Veterans General Hospital
  • États-Unis
    • Alabama
      • Ozark, Alabama, États-Unis, 36360
        • IICR, Inc. (DBA: International Institute of Clinical Research)
    • Arizona
      • Goodyear, Arizona, États-Unis, 85395
        • Dedicated Clinical Research
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72211
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
    • California
      • Anaheim, California, États-Unis, 92801
        • Anaheim Clinical Trials, LLC
      • La Habra, California, États-Unis, 90631
        • Omega Clinical Trials, LLC
      • National City, California, États-Unis, 91950
        • Synergy Clinical Research Center
      • Oakland, California, États-Unis, 94607
        • Pacific Research Partners, LLC
      • Oceanside, California, États-Unis, 92054
        • North County Clinical Research
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • University of Colorado Anschutz Medical Campus
      • Colorado Springs, Colorado, États-Unis, 80910
        • MCB Clinical Research Centers
      • Denver, Colorado, États-Unis, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06520
        • Yale University
      • New Haven, Connecticut, États-Unis, 06511
        • Connecticut Mental Health Center
      • New Haven, Connecticut, États-Unis, 06511
        • Yale University, SATU
    • Florida
      • DeLand, Florida, États-Unis, 32720
        • Avail Clinical Research, LLC
      • Kissimmee, Florida, États-Unis, 34741
        • Hope Clinical Research
      • Maitland, Florida, États-Unis, 32751
        • Florida Clinical Research Center, LLC
      • Miami, Florida, États-Unis, 33126
        • Pharmax Research Clinic, Inc.
      • Miami, Florida, États-Unis, 33144
        • L & L Research Choices
      • North Bay Village, Florida, États-Unis, 33141
        • Bravo Health Care Center
      • Orange City, Florida, États-Unis, 32763
        • Medical Research Group of Central Florida
      • Saint Petersburg, Florida, États-Unis, 33716
        • Comprehensive Clinical Development Inc.
    • Idaho
      • Meridian, Idaho, États-Unis, 83646
        • Solaris Clinical Research
      • Meridian, Idaho, États-Unis, 83646
        • Barney Greenspan, Ph.D
    • Indiana
      • Evansville, Indiana, États-Unis, 47715
        • Midwest Behavioral Health
      • Indianapolis, Indiana, États-Unis, 46260
        • Goldpoint Clinical Research, LLC
      • Newburgh, Indiana, États-Unis, 47630
        • Pedia Research, LLC
    • Kansas
      • Wichita, Kansas, États-Unis, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Bardstown, Kentucky, États-Unis, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, États-Unis, 40509
        • Central Kentucky Research Associates, Inc.
      • Owensboro, Kentucky, États-Unis, 42301
        • Pedia Research, LLC
      • Owensboro, Kentucky, États-Unis, 42303
        • Research Integrity, LLC
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70114
        • Louisiana Research Associates, Inc
    • Massachusetts
      • Watertown, Massachusetts, États-Unis, 02472
        • Adams Clinical Trials, LLC
    • Michigan
      • Rochester Hills, Michigan, États-Unis, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • Kansas City, Missouri, États-Unis, 64114
        • The Center for Pharmaceutical Research, P.C.
      • O'Fallon, Missouri, États-Unis, 63368
        • Psychiatric Care & Research Center
      • Saint Louis, Missouri, États-Unis, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, États-Unis, 68526
        • Premier Psychiatric Research Institute, LLC
    • North Carolina
      • Raleigh, North Carolina, États-Unis, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, États-Unis, 27612
        • Wake Internal Medicine Consultants, Inc
      • Wilmington, North Carolina, États-Unis, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Canton, Ohio, États-Unis, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Toledo, Ohio, États-Unis, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73116
        • Cutting Edge Research Group
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Medical University of South Carolina
      • Mount Pleasant, South Carolina, États-Unis, 29464
        • Coastal Carolina Research Center
    • Texas
      • Dallas, Texas, États-Unis, 75231
        • FutureSearch Trials of Dallas, L.P.
      • DeSoto, Texas, États-Unis, 75115
        • InSite Clinical Research, LLC
      • Lake Jackson, Texas, États-Unis, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, États-Unis, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, États-Unis, 78230
        • Thomas Murray DeMoor, MD
    • Virginia
      • Richmond, Virginia, États-Unis, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Kirkland, Washington, États-Unis, 98033
        • Eastside Therapeutic Resource
      • Richland, Washington, États-Unis, 99352
        • Zain Research, LLC
    • Wisconsin
      • Middleton, Wisconsin, États-Unis, 53562
        • Dean Foundation for Health Research and Education

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 19 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: 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
Expérimental: 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
Médicament: 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
Comparateur placebo: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Médicament: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2011

Achèvement primaire (Réel)

1 janvier 2018

Achèvement de l'étude (Réel)

1 janvier 2018

Dates d'inscription aux études

Première soumission

9 mars 2011

Première soumission répondant aux critères de contrôle qualité

9 mars 2011

Première publication (Estimation)

11 mars 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2018

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A3051073
  • CHANTIX (Autre identifiant: Alias Study Number)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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