Back to resultsStudy Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders (EAGLES)
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
varenicline tartrate
bupropion hydrochloride
Nicotine Replacement Therapy Patch
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring smoking cessation, psychiatric disease
Eligibility 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)
Sites / Locations
- Coastal Clinical Research, Inc.
- NoesisPharma Research
- Pharmacology Research Institute
- Synergy Clinical Research of Escondido
- Sun Valley Research Center
- Omega Clinical Trials
- Pacific Treatment and Research Center UC San Diego Health System
- Pharmacology Research Institute
- David Geffen School of Medicine at University of California, Los Angeles
- Pharmacology Research Institute
- North County Clinical Research
- Neuropsychiatric Research Center of Orange County
- California Neuroscience Research Medical Group, Inc.
- University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program
- Western Affiliated Research Institute
- Comprehensive Psychiatric Care
- Neuropsychiatric Research Center of Southwest Florida
- Broward Research Group
- Jacksonville Center for Clinical Research
- Mayo Clinic
- Clinical Neuroscience Solutions,Inc.
- Meridien Research
- Renstar Medical Research
- Ocala Psychiatric Associates
- Clinical Neuroscience Solutions, Inc
- Meridien Research
- Northwest Behavioral Research Center
- Clinical Research Atlanta
- Advanced Clinical Research
- Northwest Neurobehavioral Health
- AMR-Baber Research Inc.
- American Health Network of IN, LLC
- Davis Clinic, Incorporated
- Goldpoint Clinical Research, LLC
- Vince and Associates Clinical Research
- Heartland Research Associates, LLC
- Central Kentucky Research Associates, Inc.
- Kentucky Research Group
- A Professional Corporation dba The Center for Sexual Health
- Maine Research Associates
- Community Clinical Services
- Massachusetts General Hospital
- Milford Emergency Associates, Incorporated
- Rahim Shafa, MD
- University of Minnesota- TC
- Mayo Clinic
- Precise Research Centers
- The Center for Pharmaceutical Research, PC
- Mercy Health Research
- University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
- Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building
- Social Psychiatry Research Institute Clinical Trials LLC
- Regional Clinical Research, Inc.
- Tooley Group
- PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
- Wake Internal Medicine Consultants, Inc
- Wake Research Associates, LLC
- Midwest Clinical Research Center
- Oregon Health and Sciences University
- Southeastern PA Medical Institute
- Belmont Center for Comprehensive Treatment
- CRI Worldwide, LLC
- East Side Clinical Laboratory
- Lincoln Research
- Coastal Carolina Research Center
- New Orleans Center for Clinical Research
- Volunteer Research Group
- Clinical NeuroScience Solutions, Inc.
- Clinical Research Associates, Inc.
- James G. Kyser, MD
- FutureSearch Clinical Trials, L.P.
- InSite Clinical Research
- The University of Texas M.D. Anderson Cancer Center
- Peninsula Psychotherapy Center, LLC
- Clinical Research Associates of Tidewater
- University of Wisconsin School of Medicine and Public Health
- University of Wisconsin Hospital and Clinics
- Centro Medico Dra. De Salvo
- Centro de Investigacion Clinica WM
- Royal Brisbane & Women's Hospital
- Monash Alfred Psychiatry Research Centre
- Hospital de Messejana Dr. Carlos Alberto Studart Gomes
- Irmandade da Santa Casa de Misericórdia Porto Alegre
- Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
- Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
- Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
- Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
- MBAL Dr. Hristo Stambolski EOOD
- DPB Sv. Ivan Rilski
- UMBAL Dr. Georgi Stranski EAD,
- UMBAL Sveti Georgi EAD, Klinika po psihiatriya
- SBALPFZ - Ruse EOOD
- Tsentar za psihichno zdrave - Ruse EOOD
- Meditsinski Tsentar ¿Sveti Naum¿ EOOD
- MHATNP Sveti Naum SJsc.
- Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,
- Hamilton Medical Research Group
- Medical Research Associates
- University of Ottawa Heart Institute
- Canadian Phase Onward Inc.
- Dr. Felix Yaroshevsky
- Centre for Addiction and Mental Health (CAMH)
- Centre of Addiction and Mental Health Pharmacy
- Diex Research Sherbrooke Inc.
- Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
- Centro Respiratorio Integral (CENRESIN Ltda.)
- CCBR A/S
- CCBR A/S
- Mehiläinen Leppävaara
- Savon Psykiatripalvelu Oy
- Mehiläinen Nummela
- Oulu Mentalcare
- Porin Lääkäritalo Oy
- PEL, Psykiatrian ErikoiLääkärit
- ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
- Klinische Forschung Berlin-Mitte GmbH
- emovis GmbH
- Universitaetsklinikum Freiburg
- Klinische Forschung Hamburg GmbH
- Ludwig Maximilians-Universitaet Muenchen
- Universitaetsklinik Tuebingen
- Centro Respiratorio de Mexico S.C.
- Consultarios de Medicina Especializada del Sector Privado
- Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
- Centro de Estudios Clinicos y Especialidades Medicas S.C.
- Lakeland Clinical Trials
- FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
- FSBI Moscow Scientific Research Institute of Psychiatry"
- Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
- Clinical Mental Hospital #12 of Moscow Healthcare Department
- Clinical Psychiatric Hospital #1 of Nizhni Novgorod
- FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
- SBEI HPE ##Smolensk State Medical Academy## of MoH of RF
- Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation
- St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
- State Healthcare Institution "Psychoneurological Dispensary #2
- Psychiatricka ambulancia, Mentum, s.r.o.
- Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
- Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
- Psychiatricka ambulancia, PsychoLine s.r.o.
- Nemocnica s poliklinikou sv. Barbory Roznava a.s.
- Flexivest Fourteen Research Center
- Worthwhile Clinical Trials
- Vista Clinic
- Soweto Clinical Trials Centre
- I Engelbrecht Research Pty, Ltd
- Midrand Medical Centre
- Private Practice
- Randles Road Medical Centre
- Dr John OBrien Incorporated
- Hospital de La Santa Creu I Sant Pau
- Hospital General Universitari Vall d'Hebron
- Hospital Clinic I Provincial
- Hospital San Pedro de Alcantara
- Unidad Especializada en Tabaquismo de la Comunidad de Madrid
- Centro de Salud Torrero La Paz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
placebo
varenicline
bupropion
Nicotine Replacement Therapy Patch
Arm Description
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.
Outcomes
Primary Outcome Measures
Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
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 (%), by Cohort
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
Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
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.
Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
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.
Occurrence of the Components of NPS AE Primary Endpoint (Overall)
The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.
Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
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.
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
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.
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
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.
Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
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.
Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
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.
HADS Total Score, Psychiatric History Cohort
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.
HADS Total Score (Overall)
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.
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
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.
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
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.
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
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.
Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit
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.
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
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).
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
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).
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
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).
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
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).
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
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).
CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
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).
7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
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?
7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
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?
7-Day Point Prevalence of Abstinence (Overall)
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?
Full Information
NCT ID
NCT01456936
First Posted
October 14, 2011
Last Updated
May 9, 2016
Sponsor
Pfizer
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01456936
Brief Title
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Acronym
EAGLES
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
smoking cessation, psychiatric disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
varenicline
Arm Type
Active Comparator
Arm Title
bupropion
Arm Type
Active Comparator
Arm Title
Nicotine Replacement Therapy Patch
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Triple dummy placebo for each treatment arm
Intervention Type
Drug
Intervention Name(s)
varenicline tartrate
Other Intervention Name(s)
Chantix; Champix
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
bupropion hydrochloride
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy Patch
Other Intervention Name(s)
NRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Estimated NPS AE Rate (%), by Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary Outcome Measure Information:
Title
Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of the Components of NPS AE Primary Endpoint (Overall)
Description
The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
Description
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.
Time Frame
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
Description
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.
Time Frame
Baseline to Week 24
Title
HADS Total Score, Psychiatric History Cohort
Description
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.
Time Frame
Baseline to Week 24
Title
HADS Total Score (Overall)
Description
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.
Time Frame
Baseline to Week 24
Title
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
Description
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.
Time Frame
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
Description
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.
Time Frame
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
Description
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.
Time Frame
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Title
Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit
Description
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.
Time Frame
Baseline to Week 24
Title
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
Description
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).
Time Frame
Week 9 through Week 12
Title
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
Description
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).
Time Frame
Week 9 through Week 12
Title
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
Description
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).
Time Frame
Week 9 through Week 12
Title
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
Description
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).
Time Frame
Week 9 through Week 24
Title
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
Description
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).
Time Frame
Week 9 through Week 24
Title
CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
Description
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).
Time Frame
Week 9 through Week 24
Title
7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
Description
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?
Time Frame
24 Weeks
Title
7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
Description
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?
Time Frame
24 Weeks
Title
7-Day Point Prevalence of Abstinence (Overall)
Description
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?
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
NoesisPharma Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Omega Clinical Trials
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Pacific Treatment and Research Center UC San Diego Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
David Geffen School of Medicine at University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Clinical Neuroscience Solutions,Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ocala Psychiatric Associates
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwest Neurobehavioral Health
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
AMR-Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
American Health Network of IN, LLC
City
Indianaopolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Davis Clinic, Incorporated
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Goldpoint Clinical Research, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
A Professional Corporation dba The Center for Sexual Health
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Community Clinical Services
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Milford Emergency Associates, Incorporated
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Rahim Shafa, MD
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
University of Minnesota- TC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
The Center for Pharmaceutical Research, PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Mercy Health Research
City
St.Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Social Psychiatry Research Institute Clinical Trials LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Tooley Group
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Southeastern PA Medical Institute
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Belmont Center for Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
East Side Clinical Laboratory
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Lincoln Research
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical NeuroScience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
James G. Kyser, MD
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
FutureSearch Clinical Trials, L.P.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77230-1439
Country
United States
Facility Name
Peninsula Psychotherapy Center, LLC
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711-2027
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Centro Medico Dra. De Salvo
City
Ciudad Autonoma de Bs. As
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Centro de Investigacion Clinica WM
City
Mataderos
State/Province
Buenos Aires
ZIP/Postal Code
C1440BRR
Country
Argentina
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Monash Alfred Psychiatry Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60846-190
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
City
Campinas
State/Province
SP
ZIP/Postal Code
13059-740
Country
Brazil
Facility Name
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05017-000
Country
Brazil
Facility Name
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
MBAL Dr. Hristo Stambolski EOOD
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
DPB Sv. Ivan Rilski
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
UMBAL Dr. Georgi Stranski EAD,
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMBAL Sveti Georgi EAD, Klinika po psihiatriya
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
SBALPFZ - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Tsentar za psihichno zdrave - Ruse EOOD
City
Ruse
ZIP/Postal Code
7004
Country
Bulgaria
Facility Name
Meditsinski Tsentar ¿Sveti Naum¿ EOOD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
MHATNP Sveti Naum SJsc.
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD,
City
Troyan
ZIP/Postal Code
5600
Country
Bulgaria
Facility Name
Hamilton Medical Research Group
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Medical Research Associates
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Facility Name
Dr. Felix Yaroshevsky
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 3C7
Country
Canada
Facility Name
Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Facility Name
Centre of Addiction and Mental Health Pharmacy
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
City
Talca
State/Province
Maule
ZIP/Postal Code
3460001
Country
Chile
Facility Name
Centro Respiratorio Integral (CENRESIN Ltda.)
City
Quillota
State/Province
Valparaiso, V Region
ZIP/Postal Code
2260877
Country
Chile
Facility Name
CCBR A/S
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Mehiläinen Leppävaara
City
Espoo
ZIP/Postal Code
02600
Country
Finland
Facility Name
Savon Psykiatripalvelu Oy
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Mehiläinen Nummela
City
Nummela
ZIP/Postal Code
03100
Country
Finland
Facility Name
Oulu Mentalcare
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Porin Lääkäritalo Oy
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
PEL, Psykiatrian ErikoiLääkärit
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04157
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Ludwig Maximilians-Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitaetsklinik Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Centro Respiratorio de Mexico S.C.
City
Mexico
State/Province
D.f.
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Consultarios de Medicina Especializada del Sector Privado
City
Colonia Hipodromo Condesa
State/Province
Mexico DF
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Facility Name
Centro de Estudios Clinicos y Especialidades Medicas S.C.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
FSBI Moscow Scientific Research Institute of Psychiatry"
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Clinical Mental Hospital #12 of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
City
Nizhni Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
SBEI HPE ##Smolensk State Medical Academy## of MoH of RF
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Smolensk State Medical Academy of Ministry of Healthcare of Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
State Healthcare Institution "Psychoneurological Dispensary #2
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Psychiatricka ambulancia, Mentum, s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Vavrusová consulting s.r.o., Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
Psychiatricka ambulancia, PsychoLine s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia
Facility Name
Flexivest Fourteen Research Center
City
Bellville
State/Province
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Worthwhile Clinical Trials
City
Benoni, Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Vista Clinic
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Soweto Clinical Trials Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
Facility Name
I Engelbrecht Research Pty, Ltd
City
Lyttelton
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Midrand Medical Centre
City
Midrand
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Private Practice
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Randles Road Medical Centre
City
Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Dr John OBrien Incorporated
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Unidad Especializada en Tabaquismo de la Comunidad de Madrid
City
Madrid
ZIP/Postal Code
28015
Country
Spain
Facility Name
Centro de Salud Torrero La Paz
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35611069
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PubMed Identifier
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Correa JB, Lawrence D, McKenna BS, Gaznick N, Saccone PA, Dubrava S, Doran N, Anthenelli RM. Psychiatric Comorbidity and Multimorbidity in the EAGLES Trial: Descriptive Correlates and Associations With Neuropsychiatric Adverse Events, Treatment Adherence, and Smoking Cessation. Nicotine Tob Res. 2021 Aug 29;23(10):1646-1655. doi: 10.1093/ntr/ntab056.
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PubMed Identifier
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PubMed Identifier
33138708
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Evins AE, West R, Benowitz NL, Russ C, Lawrence D, McRae T, Maravic MC, Heffner JL, Anthenelli RM. Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES. Psychiatr Serv. 2021 Jan 1;72(1):7-15. doi: 10.1176/appi.ps.202000032. Epub 2020 Nov 3.
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Learn more about this trial
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
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