0 Ratings
ID

28101

Description

Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00554840

Link

https://clinicaltrials.gov/show/NCT00554840

Keywords

Versions (1)
  1. 12/18/17 12/18/17 -
Copyright Holder

See clinicaltrials.gov

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December 18, 2017

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License

Creative Commons BY 4.0
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    Eligibility Cigarette Smoking NCT00554840

    English

    Eligibility Cigarette Smoking NCT00554840

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 18-64
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    regular ten cigarette per day smoker for one year
    Description

    Tobacco use Number of cigarettes per day

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C3694146
    nicotine dependency score greater than or equal to four
    Description

    Nicotine Dependence Score

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0028043
    UMLS CUI [1,2]
    C0449820
    dsm-iv diagnosis of schizophrenia or schizoaffective disorder
    Description

    Schizophrenia | Schizoaffective Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    UMLS CUI [2]
    C0036337
    psychiatric medication regimen unchanged for at least 90 days
    Description

    Pharmacotherapy Psychiatric unchanged

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0205487
    UMLS CUI [1,3]
    C0442739
    psychiatric medication dosage unchanged for at least 30 days
    Description

    Psychiatric drugs Dosage unchanged

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1979799
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0442739
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    psychiatric hospitalization in last 6 months
    Description

    Psychiatric hospitalization

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748061
    meets criteria for current major depressive disorder or has a score of greater than 10 on the calgary depression scale (see withdrawal criteria)
    Description

    Major Depressive Disorder | Depression scale

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    UMLS CUI [2]
    C0679604
    suicide or homicide ideation with a plan in the last six months
    Description

    Feeling suicidal | Homicidal thoughts | Planning suicide | Homicidal plan

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0424000
    UMLS CUI [2]
    C0455204
    UMLS CUI [3]
    C0424001
    UMLS CUI [4]
    C2046966
    life time history of suicide attempt
    Description

    History of suicide attempt Lifetime

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0455507
    UMLS CUI [1,2]
    C4071830
    has had a diagnosis of schizophrenia or schizoaffective disorder for less than three years
    Description

    Schizophrenia Duration | Schizoaffective Disorder Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036341
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [2,1]
    C0036337
    UMLS CUI [2,2]
    C0449238
    current treatment with bupropion sr
    Description

    Bupropion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085208
    dsm-iv diagnosis of alcohol or substance dependence within last 6 months*
    Description

    Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038580
    dsm-iv diagnosis of alcohol or substance abuse within three months *
    Description

    Substance Use Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    pregnancy or lactation in females (+hcg)
    Description

    Pregnancy | hcg positive | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0241904
    UMLS CUI [3]
    C0006147
    use of tobacco product other than cigarettes
    Description

    Tobacco use | Exception Cigarette

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0677453
    use of nicotine replacements
    Description

    Nicotine Replacement Products Use of

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3179143
    UMLS CUI [1,2]
    C1524063
    unstable or serious medical condition in last 6 months
    Description

    Medical condition Unstable | Medical condition Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0205404
    regular use of cimetidine (otc or rx) *substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
    Description

    Cimetidine Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008783
    UMLS CUI [1,2]
    C0205272
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    Similar models

    Eligibility Cigarette Smoking NCT00554840

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 18-64
    boolean
    C0001779 (UMLS CUI [1])
    Tobacco use Number of cigarettes per day
    Item
    regular ten cigarette per day smoker for one year
    boolean
    C0543414 (UMLS CUI [1,1])
    C3694146 (UMLS CUI [1,2])
    Nicotine Dependence Score
    Item
    nicotine dependency score greater than or equal to four
    boolean
    C0028043 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Schizophrenia | Schizoaffective Disorder
    Item
    dsm-iv diagnosis of schizophrenia or schizoaffective disorder
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    Pharmacotherapy Psychiatric unchanged
    Item
    psychiatric medication regimen unchanged for at least 90 days
    boolean
    C0013216 (UMLS CUI [1,1])
    C0205487 (UMLS CUI [1,2])
    C0442739 (UMLS CUI [1,3])
    Psychiatric drugs Dosage unchanged
    Item
    psychiatric medication dosage unchanged for at least 30 days
    boolean
    C1979799 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0442739 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Psychiatric hospitalization
    Item
    psychiatric hospitalization in last 6 months
    boolean
    C0748061 (UMLS CUI [1])
    Major Depressive Disorder | Depression scale
    Item
    meets criteria for current major depressive disorder or has a score of greater than 10 on the calgary depression scale (see withdrawal criteria)
    boolean
    C1269683 (UMLS CUI [1])
    C0679604 (UMLS CUI [2])
    Feeling suicidal | Homicidal thoughts | Planning suicide | Homicidal plan
    Item
    suicide or homicide ideation with a plan in the last six months
    boolean
    C0424000 (UMLS CUI [1])
    C0455204 (UMLS CUI [2])
    C0424001 (UMLS CUI [3])
    C2046966 (UMLS CUI [4])
    History of suicide attempt Lifetime
    Item
    life time history of suicide attempt
    boolean
    C0455507 (UMLS CUI [1,1])
    C4071830 (UMLS CUI [1,2])
    Schizophrenia Duration | Schizoaffective Disorder Duration
    Item
    has had a diagnosis of schizophrenia or schizoaffective disorder for less than three years
    boolean
    C0036341 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C0036337 (UMLS CUI [2,1])
    C0449238 (UMLS CUI [2,2])
    Bupropion
    Item
    current treatment with bupropion sr
    boolean
    C0085208 (UMLS CUI [1])
    Substance Dependence
    Item
    dsm-iv diagnosis of alcohol or substance dependence within last 6 months*
    boolean
    C0038580 (UMLS CUI [1])
    Substance Use Disorders
    Item
    dsm-iv diagnosis of alcohol or substance abuse within three months *
    boolean
    C0038586 (UMLS CUI [1])
    Pregnancy | hcg positive | Breast Feeding
    Item
    pregnancy or lactation in females (+hcg)
    boolean
    C0032961 (UMLS CUI [1])
    C0241904 (UMLS CUI [2])
    C0006147 (UMLS CUI [3])
    Tobacco use | Exception Cigarette
    Item
    use of tobacco product other than cigarettes
    boolean
    C0543414 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0677453 (UMLS CUI [2,2])
    Nicotine Replacement Products Use of
    Item
    use of nicotine replacements
    boolean
    C3179143 (UMLS CUI [1,1])
    C1524063 (UMLS CUI [1,2])
    Medical condition Unstable | Medical condition Serious
    Item
    unstable or serious medical condition in last 6 months
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C3843040 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    Cimetidine Regular
    Item
    regular use of cimetidine (otc or rx) *substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
    boolean
    C0008783 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
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