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ID

36128

Descrizione

The objective of this study is to determine the mechanisms by which varenicline, an effective smoking cessation treatment, protects against relapse. Varenicline will be administered in smokers with schizophrenia and control smokers using a randomized, double-blind, cross-over design. Smokers will be asked to stop smoking overnight; the next day the ability to resist smoking will be assessed in a laboratory smoking lapse paradigm. Measures of tobacco craving, reinforcement and withdrawal-related cognitive dysfunction will be correlated with time to lapse. The results could have significant clinical implications by identifying mechanisms by which smokers with schizophrenia are at more risk for relapse than the general population, leading to the development of more effective smoking cessation therapies. ODM derived from: https://clinicaltrials.gov/show/NCT01850953

collegamento

https://clinicaltrials.gov/show/NCT01850953

Keywords

versioni (1)
  1. 17/04/19 17/04/19 -
Titolare del copyright

Centre for Addiction and Mental Health Toronto

Caricato su

17 aprile 2019

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia NCT01850953

    Inglese

    Eligibility

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Patient is a cigarette smoker (smokes ≥ 10 cigarettes per day)
    Descrizione

    Smoker

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    Non-treatment seeking (i.e., not trying to quit as indicated by <7 on the contemplation ladder)
    Descrizione

    Non-treatment seeking

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0679860
    UMLS CUI [1,2]
    C1301732
    Patient aged 18-55
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Patient has an intelligence quotient (iq) ≥80 on the wechsler test of adult reading [89]
    Descrizione

    IQ

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0456149
    UMLS CUI [1,2]
    C4505449
    Patient with fagerstrom test of nicotine dependence (ftnd) ≥4 [90]
    Descrizione

    Nicotine dependency

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0028043
    UMLS CUI [1,2]
    C0451156
    Patient must meet structured clinical interview for the diagnostic and statistical manual for mental disorders (scid-iv) diagnosis criteria for schizophrenia or schizoaffective disorder; be in stable remission from positive symptoms of psychosis as judged by a positive and negative syndrome scale (panss) positive score total score <70, and receiving a stable dose of antipsychotics for >1month.
    Descrizione

    Medical condition of patient

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C1537054
    UMLS CUI [1,3]
    C0036341
    UMLS CUI [2,1]
    C0011900
    UMLS CUI [2,2]
    C1537054
    UMLS CUI [2,3]
    C0036337
    UMLS CUI [3,1]
    C0544452
    UMLS CUI [3,2]
    C0205360
    UMLS CUI [3,3]
    C4086747
    UMLS CUI [4]
    C1319421
    Control participant will not be taking any psychotropic medications at the time of enrollment and will not meet diagnostic criteria for any Axis I disorder, except past history of major depression or an anxiety disorder if in remission for at least one year.
    Descrizione

    Medical condition of control participant

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3532643
    UMLS CUI [2]
    C0236870
    UMLS CUI [3,1]
    C0332300
    UMLS CUI [3,2]
    C0270461
    UMLS CUI [3,3]
    C0439234
    UMLS CUI [4,1]
    C0332300
    UMLS CUI [4,2]
    C0003469
    UMLS CUI [4,3]
    C0544452
    UMLS CUI [4,4]
    C0439234
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Patient with substance use (except nicotine or caffeine) in the last month
    Descrizione

    Substance use

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0237123
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C0543414
    UMLS CUI [2,3]
    C0332185
    UMLS CUI [3,1]
    C0332300
    UMLS CUI [3,2]
    C0006644
    UMLS CUI [3,3]
    C0332185
    Patient with a history of alcohol/drug abuse in the 3 months before study enrollment
    Descrizione

    Alcohol/drug abuse history

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0038586
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C4041024
    Patient uses opioids (meperidine, oxycodone, methadone, etc)
    Descrizione

    Use of opioids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0240602
    UMLS CUI [2]
    C0025376
    UMLS CUI [3]
    C0030049
    UMLS CUI [4]
    C0025605
    Patient currently uses smoking cessation aids (e.g., nicotine replacement therapy, bupropion or varenicline)
    Descrizione

    Use of smoking cessation aids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0085134
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [2]
    C1278444
    UMLS CUI [3]
    C0085208
    UMLS CUI [4]
    C4304585
    Patient is pregnant or breastfeeding
    Descrizione

    Pregnancy or nursing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Patient with a history of renal insufficiency or a hypersensitivity to varenicline (champix®)
    Descrizione

    Contraindications to varenicline

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1565489
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1569608
    Patient with a history of neurological illness like epilepsy or medical condition known to significantly influence neurocognitive function
    Descrizione

    Neurological illess

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2186518
    UMLS CUI [2]
    C0014544
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0392760
    UMLS CUI [3,3]
    C0518895
    UMLS CUI [3,4]
    C0542341
    any other medical condition deemed relevant by the qualified investigator.
    Descrizione

    Medical condition

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3843040
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    Similar models

    Eligibility

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Smoker
    Item
    Patient is a cigarette smoker (smokes ≥ 10 cigarettes per day)
    boolean
    C0543414 (UMLS CUI [1])
    Non-treatment seeking
    Item
    Non-treatment seeking (i.e., not trying to quit as indicated by <7 on the contemplation ladder)
    boolean
    C0679860 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Age
    Item
    Patient aged 18-55
    boolean
    C0001779 (UMLS CUI [1])
    IQ
    Item
    Patient has an intelligence quotient (iq) ≥80 on the wechsler test of adult reading [89]
    boolean
    C0456149 (UMLS CUI [1,1])
    C4505449 (UMLS CUI [1,2])
    Nicotine dependency
    Item
    Patient with fagerstrom test of nicotine dependence (ftnd) ≥4 [90]
    boolean
    C0028043 (UMLS CUI [1,1])
    C0451156 (UMLS CUI [1,2])
    Medical condition of patient
    Item
    Patient must meet structured clinical interview for the diagnostic and statistical manual for mental disorders (scid-iv) diagnosis criteria for schizophrenia or schizoaffective disorder; be in stable remission from positive symptoms of psychosis as judged by a positive and negative syndrome scale (panss) positive score total score <70, and receiving a stable dose of antipsychotics for >1month.
    boolean
    C0011900 (UMLS CUI [1,1])
    C1537054 (UMLS CUI [1,2])
    C0036341 (UMLS CUI [1,3])
    C0011900 (UMLS CUI [2,1])
    C1537054 (UMLS CUI [2,2])
    C0036337 (UMLS CUI [2,3])
    C0544452 (UMLS CUI [3,1])
    C0205360 (UMLS CUI [3,2])
    C4086747 (UMLS CUI [3,3])
    C1319421 (UMLS CUI [4])
    Medical condition of control participant
    Item
    Control participant will not be taking any psychotropic medications at the time of enrollment and will not meet diagnostic criteria for any Axis I disorder, except past history of major depression or an anxiety disorder if in remission for at least one year.
    boolean
    C3532643 (UMLS CUI [1])
    C0236870 (UMLS CUI [2])
    C0332300 (UMLS CUI [3,1])
    C0270461 (UMLS CUI [3,2])
    C0439234 (UMLS CUI [3,3])
    C0332300 (UMLS CUI [4,1])
    C0003469 (UMLS CUI [4,2])
    C0544452 (UMLS CUI [4,3])
    C0439234 (UMLS CUI [4,4])
    Item Group
    C0680251 (UMLS CUI)
    Substance use
    Item
    Patient with substance use (except nicotine or caffeine) in the last month
    boolean
    C0237123 (UMLS CUI [1])
    C0332300 (UMLS CUI [2,1])
    C0543414 (UMLS CUI [2,2])
    C0332185 (UMLS CUI [2,3])
    C0332300 (UMLS CUI [3,1])
    C0006644 (UMLS CUI [3,2])
    C0332185 (UMLS CUI [3,3])
    Alcohol/drug abuse history
    Item
    Patient with a history of alcohol/drug abuse in the 3 months before study enrollment
    boolean
    C0038586 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C4041024 (UMLS CUI [1,3])
    Use of opioids
    Item
    Patient uses opioids (meperidine, oxycodone, methadone, etc)
    boolean
    C0240602 (UMLS CUI [1])
    C0025376 (UMLS CUI [2])
    C0030049 (UMLS CUI [3])
    C0025605 (UMLS CUI [4])
    Use of smoking cessation aids
    Item
    Patient currently uses smoking cessation aids (e.g., nicotine replacement therapy, bupropion or varenicline)
    boolean
    C1524063 (UMLS CUI [1,1])
    C0085134 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C1278444 (UMLS CUI [2])
    C0085208 (UMLS CUI [3])
    C4304585 (UMLS CUI [4])
    Pregnancy or nursing
    Item
    Patient is pregnant or breastfeeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Contraindications to varenicline
    Item
    Patient with a history of renal insufficiency or a hypersensitivity to varenicline (champix®)
    boolean
    C0262926 (UMLS CUI [1,1])
    C1565489 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C1569608 (UMLS CUI [2,2])
    Neurological illess
    Item
    Patient with a history of neurological illness like epilepsy or medical condition known to significantly influence neurocognitive function
    boolean
    C2186518 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    C0012634 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0518895 (UMLS CUI [3,3])
    C0542341 (UMLS CUI [3,4])
    Medical condition
    Item
    any other medical condition deemed relevant by the qualified investigator.
    boolean
    C3843040 (UMLS CUI [1])
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