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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01456936
Registration number
NCT01456936
Ethics application status
Date submitted
14/10/2011
Date registered
21/10/2011
Date last updated
10/06/2016
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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2010-022914-15
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Secondary ID [2]
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A3051123
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Universal Trial Number (UTN)
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Trial acronym
EAGLES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Condition category
Condition code
Mental Health
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - varenicline tartrate
Treatment: Drugs - bupropion hydrochloride
Treatment: Drugs - Nicotine Replacement Therapy Patch
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.
Active Comparator: varenicline -
Active Comparator: bupropion -
Active Comparator: Nicotine Replacement Therapy Patch -
Treatment: Drugs: Placebo
Triple dummy placebo for each treatment arm
Treatment: Drugs: 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
Treatment: Drugs: 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).
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
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Assessment method [1]
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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.
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Timepoint [1]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Primary outcome [2]
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Estimated NPS AE Rate (%), by Cohort
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Assessment method [2]
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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.
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Timepoint [2]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [1]
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Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
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Assessment method [1]
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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.
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Timepoint [1]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [2]
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Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
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Assessment method [2]
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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.
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Timepoint [2]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [3]
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Occurrence of the Components of NPS AE Primary Endpoint (Overall)
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Assessment method [3]
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The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.
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Timepoint [3]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [4]
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Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
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Assessment method [4]
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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.
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Timepoint [4]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [5]
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Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
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Assessment method [5]
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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.
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Timepoint [5]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [6]
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Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
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Assessment method [6]
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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.
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Timepoint [6]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [7]
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Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
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Assessment method [7]
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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.
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Timepoint [7]
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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [8]
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Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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HADS Total Score, Psychiatric History Cohort
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to Week 24
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Secondary outcome [10]
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HADS Total Score (Overall)
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline to Week 24
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Secondary outcome [11]
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Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
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Assessment method [11]
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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.
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Timepoint [11]
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Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [12]
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Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
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Assessment method [12]
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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.
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Timepoint [12]
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Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [13]
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Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
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Assessment method [13]
0
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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.
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Timepoint [13]
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Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
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Secondary outcome [14]
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Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline to Week 24
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Secondary outcome [15]
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CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
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Assessment method [15]
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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).
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Timepoint [15]
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Week 9 through Week 12
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Secondary outcome [16]
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CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
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Assessment method [16]
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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).
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Timepoint [16]
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Week 9 through Week 12
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Secondary outcome [17]
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CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
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Assessment method [17]
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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).
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Timepoint [17]
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Week 9 through Week 12
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Secondary outcome [18]
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CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
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Assessment method [18]
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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).
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Timepoint [18]
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Week 9 through Week 24
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Secondary outcome [19]
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CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
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Assessment method [19]
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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).
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Timepoint [19]
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Week 9 through Week 24
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Secondary outcome [20]
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CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
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Assessment method [20]
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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).
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Timepoint [20]
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Week 9 through Week 24
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Secondary outcome [21]
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7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
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Assessment method [21]
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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?
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Timepoint [21]
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24 Weeks
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Secondary outcome [22]
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7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
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Assessment method [22]
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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?
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Timepoint [22]
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24 Weeks
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Secondary outcome [23]
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7-Day Point Prevalence of Abstinence (Overall)
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Assessment method [23]
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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?
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Timepoint [23]
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24 Weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2015
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Sample size
Target
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Accrual to date
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Final
8144
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane & Women's Hospital - Herston
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Recruitment hospital [2]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Minnesota
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Mississippi
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Brazil
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CE
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Bourgas
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Bulgaria
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Kazanlak
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Bulgaria
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Novi Iskar
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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0
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Bulgaria
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Sofia
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0
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Bulgaria
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Troyan
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0
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Canada
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Ontario
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0
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Canada
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Quebec
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Chile
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0
0
Maule
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0
Chile
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Valparaiso, V Region
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Denmark
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Ballerup
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Denmark
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Vejle
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Finland
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Espoo
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Finland
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Kuopio
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Finland
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Nummela
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Finland
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Oulu
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Finland
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Pori
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Finland
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Turku
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Muenchen
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Germany
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Tuebingen
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Mexico
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D.f.
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Mexico
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Mexico DF
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Mexico
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Michoacan
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Mexico
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Nuevo Leon
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New Zealand
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Rotorua
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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Russian Federation
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Saint-Petersburg
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Country [69]
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Levice
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Slovakia
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Rimavska Sobota
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Slovakia
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Roznava
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South Africa
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Cape Town
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South Africa
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Gauteng
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Country [77]
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South Africa
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Kwa-Zulu Natal
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South Africa
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Kwazulu Natal
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Caceres
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Spain
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Madrid
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Spain
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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GlaxoSmithKline
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Address [1]
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0
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Country [1]
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01456936
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Pfizer CT.gov Call Center
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Address
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Pfizer
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0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01456936
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