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Trial record 18 of 648 for:    Russian Federation | Chile

Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders (EAGLES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01456936
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : May 2, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Placebo Drug: varenicline tartrate Drug: bupropion hydrochloride Drug: Nicotine Replacement Therapy Patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Study Start Date : November 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive.
Drug: Placebo
Triple dummy placebo for each treatment arm

Active Comparator: varenicline Drug: varenicline tartrate
Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks
Other Name: Chantix; Champix

Active Comparator: bupropion Drug: bupropion hydrochloride
Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).

Active Comparator: Nicotine Replacement Therapy Patch Drug: Nicotine Replacement Therapy Patch
Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Other Name: NRT




Primary Outcome Measures :
  1. Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.

  2. Estimated NPS AE Rate (%), by Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.


Secondary Outcome Measures :
  1. Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.

  2. Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.

  3. Occurrence of the Components of NPS AE Primary Endpoint (Overall) [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.

  4. Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

  5. Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

  6. Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

  7. Occurrence of the Components of Severe-only NPS AE Endpoint (Overall) [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The NPS AE endpoint was the occurrence of at least 1 treatment-emergent "severe" AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent "severe" AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.

  8. Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort [ Time Frame: Baseline to Week 24 ]
    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

  9. HADS Total Score, Psychiatric History Cohort [ Time Frame: Baseline to Week 24 ]
    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

  10. HADS Total Score (Overall) [ Time Frame: Baseline to Week 24 ]
    The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.

  11. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides.

  12. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.

  13. Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.

  14. Clinical Global Impression of Improvement (CGI‑I), "No Change" Rating by Visit [ Time Frame: Baseline to Week 24 ]
    The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as "normal, not at all ill" on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as "no change" on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs.

  15. CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort [ Time Frame: Week 9 through Week 12 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

  16. CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort [ Time Frame: Week 9 through Week 12 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

  17. CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall) [ Time Frame: Week 9 through Week 12 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).

  18. CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort [ Time Frame: Week 9 through Week 24 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

  19. CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort [ Time Frame: Week 9 through Week 24 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

  20. CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall) [ Time Frame: Week 9 through Week 24 ]
    A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).

  21. 7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort [ Time Frame: 24 Weeks ]

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?


  22. 7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort [ Time Frame: 24 Weeks ]

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?


  23. 7‑Day Point Prevalence of Abstinence (Overall) [ Time Frame: 24 Weeks ]

    A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit.

    NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
  • Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
  • For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

  • Subjects with a past or current diagnosis of one of the following disorders:

    a. Psychotic Disorders:

  • Schizophreniform
  • Delusional Disorder
  • Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456936


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Locations
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United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
NoesisPharma Research
Phoenix, Arizona, United States, 85032
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
Synergy Clinical Research of Escondido
Escondido, California, United States, 92025
Sun Valley Research Center
Imperial, California, United States, 92251
Omega Clinical Trials
La Habra, California, United States, 90631
Pacific Treatment and Research Center UC San Diego Health System
La Jolla, California, United States, 92037
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, United States, 90095
Pharmacology Research Institute
Newport Beach, California, United States, 92660
North County Clinical Research
Oceanside, California, United States, 92056
Neuropsychiatric Research Center of Orange County
Orange, California, United States, 92868
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Colorado
University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute
Denver, Colorado, United States, 80209
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Broward Research Group
Hollywood, Florida, United States, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Mayo Clinic
Jacksonville, Florida, United States, 32224
Clinical Neuroscience Solutions,Inc.
Jacksonville, Florida, United States, 32256
Meridien Research
Lakeland, Florida, United States, 33805
Renstar Medical Research
Ocala, Florida, United States, 34471
Ocala Psychiatric Associates
Ocala, Florida, United States, 34474
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
Meridien Research
Tampa, Florida, United States, 33634
United States, Georgia
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
Northwest Neurobehavioral Health
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Inc.
Naperville, Illinois, United States, 60563
United States, Indiana
American Health Network of IN, LLC
Indianaopolis, Indiana, United States, 46254
Davis Clinic, Incorporated
Indianapolis, Indiana, United States, 46250
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
Kentucky Research Group
Louisville, Kentucky, United States, 40218
United States, Louisiana
A Professional Corporation dba The Center for Sexual Health
Metairie, Louisiana, United States, 70002
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
Community Clinical Services
Lewiston, Maine, United States, 04240
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Milford Emergency Associates, Incorporated
Milford, Massachusetts, United States, 01757
Rahim Shafa, MD
Milford, Massachusetts, United States, 01757
United States, Minnesota
University of Minnesota- TC
Minneapolis, Minnesota, United States, 55414
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
Mercy Health Research
St.Louis, Missouri, United States, 63141
United States, New Jersey
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building
Princeton, New Jersey, United States, 08540
United States, New York
Social Psychiatry Research Institute Clinical Trials LLC
Brooklyn, New York, United States, 11235
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
United States, North Carolina
Tooley Group
Cary, North Carolina, United States, 27511
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, United States, 27518
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, United States, 27612
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Southeastern PA Medical Institute
Broomall, Pennsylvania, United States, 19008
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States, 19131
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, Rhode Island
East Side Clinical Laboratory
Lincoln, Rhode Island, United States, 02865
Lincoln Research
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
Clinical NeuroScience Solutions, Inc.
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
James G. Kyser, MD
Nashville, Tennessee, United States, 37203
United States, Texas
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States, 78731
InSite Clinical Research
DeSoto, Texas, United States, 75115
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77230-1439
United States, Virginia
Peninsula Psychotherapy Center, LLC
Newport News, Virginia, United States, 23606
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53711-2027
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Argentina
Centro Medico Dra. De Salvo
Ciudad Autonoma de Bs. As, Buenos Aires, Argentina, C1426ABP
Centro de Investigacion Clinica WM
Mataderos, Buenos Aires, Argentina, C1440BRR
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Australia, Victoria
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004
Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, CE, Brazil, 60846-190
Irmandade da Santa Casa de Misericórdia Porto Alegre
Porto Alegre, RS, Brazil, 90035-074
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, RS, Brazil, 90610-000
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
Campinas, SP, Brazil, 13059-740
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
Sao Paulo, SP, Brazil, 05017-000
Bulgaria
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
Bourgas, Bulgaria, 8000
MBAL Dr. Hristo Stambolski EOOD
Kazanlak, Bulgaria, 6100
DPB Sv. Ivan Rilski
Novi Iskar, Bulgaria, 1282
UMBAL Dr. Georgi Stranski EAD,
Pleven, Bulgaria, 5800
UMBAL Sveti Georgi EAD, Klinika po psihiatriya
Plovdiv, Bulgaria, 4002
SBALPFZ - Ruse EOOD
Ruse, Bulgaria, 7002
Tsentar za psihichno zdrave - Ruse EOOD
Ruse, Bulgaria, 7004
Meditsinski Tsentar ¿Sveti Naum¿ EOOD
Sofia, Bulgaria, 1113
MHATNP Sveti Naum SJsc.
Sofia, Bulgaria, 1113
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,
Troyan, Bulgaria, 5600
Canada, Ontario
Hamilton Medical Research Group
Hamilton, Ontario, Canada, L8M 1K7
Medical Research Associates
Mississauga, Ontario, Canada, L5M 4N4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3J 2C5
Dr. Felix Yaroshevsky
Toronto, Ontario, Canada, M4W 3C7
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M5S 2S1
Centre of Addiction and Mental Health Pharmacy
Toronto, Ontario, Canada, M6J 1H4
Canada, Quebec
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Chile
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
Talca, Maule, Chile, 3460001
Centro Respiratorio Integral (CENRESIN Ltda.)
Quillota, Valparaiso, V Region, Chile, 2260877
Denmark
CCBR A/S
Ballerup, Denmark, 2750
CCBR A/S
Vejle, Denmark, 7100
Finland
Mehiläinen Leppävaara
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy
Kuopio, Finland, 70110
Mehiläinen Nummela
Nummela, Finland, 03100
Oulu Mentalcare
Oulu, Finland, 90100
Porin Lääkäritalo Oy
Pori, Finland, 28100
PEL, Psykiatrian ErikoiLääkärit
Turku, Finland, 20100
Germany
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
Leipzig, Sachsen, Germany, 04157
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
emovis GmbH
Berlin, Germany, 10629
Universitaetsklinikum Freiburg
Freiburg, Germany, 79104
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
Ludwig Maximilians-Universitaet Muenchen
Muenchen, Germany, 80336
Universitaetsklinik Tuebingen
Tuebingen, Germany, 72076
Mexico
Centro Respiratorio de Mexico S.C.
Mexico, D.f., Mexico, 14050
Consultarios de Medicina Especializada del Sector Privado
Colonia Hipodromo Condesa, Mexico DF, Mexico, 06100
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
Morelia, Michoacan, Mexico, 58249
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo Leon, Mexico, 64620
New Zealand
Lakeland Clinical Trials
Rotorua, New Zealand, 3010
Russian Federation
FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
Moscow, Russian Federation, 107076
FSBI Moscow Scientific Research Institute of Psychiatry"
Moscow, Russian Federation, 107076
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
Moscow, Russian Federation, 117152
Clinical Mental Hospital #12 of Moscow Healthcare Department
Moscow, Russian Federation, 125367
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
Nizhni Novgorod, Russian Federation, 603155
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
Saint-Petersburg, Russian Federation, 192019
SBEI HPE ##Smolensk State Medical Academy## of MoH of RF
Smolensk, Russian Federation, 214019
Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation
Smolensk, Russian Federation, 214019
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
St. Petersburg, Russian Federation, 190121
State Healthcare Institution "Psychoneurological Dispensary #2
St. Petersburg, Russian Federation, 197341
Slovakia
Psychiatricka ambulancia, Mentum, s.r.o.
Bratislava, Slovakia, 82007
Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
Levice, Slovakia, 93401
Psychiatricka ambulancia, PsychoLine s.r.o.
Rimavska Sobota, Slovakia, 979 01
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
Roznava, Slovakia, 04801
South Africa
Flexivest Fourteen Research Center
Bellville, Cape Town, South Africa, 7530
Worthwhile Clinical Trials
Benoni, Johannesburg, Gauteng, South Africa, 1500
Vista Clinic
Centurion, Gauteng, South Africa, 0157
Soweto Clinical Trials Centre
Johannesburg, Gauteng, South Africa, 1818
I Engelbrecht Research Pty, Ltd
Lyttelton, Gauteng, South Africa, 0157
Midrand Medical Centre
Midrand, Gauteng, South Africa, 1685
Private Practice
Durban, Kwa-Zulu Natal, South Africa, 4091
Randles Road Medical Centre
Durban, Kwazulu Natal, South Africa, 4091
Dr John OBrien Incorporated
Cape Town, Western Cape, South Africa, 8001
Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital General Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Unidad Especializada en Tabaquismo de la Comunidad de Madrid
Madrid, Spain, 28015
Centro de Salud Torrero La Paz
Zaragoza, Spain, 50007
Sponsors and Collaborators
Pfizer
GlaxoSmithKline
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01456936     History of Changes
Other Study ID Numbers: A3051123
2010-022914-15 ( EudraCT Number )
EAGLES ( Other Identifier: Alias Study Number )
First Posted: October 21, 2011    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: June 10, 2016
Last Verified: May 2016
Keywords provided by Pfizer:
smoking cessation
psychiatric disease
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms
Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors