ID

36128

Description

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

Link

https://clinicaltrials.gov/show/NCT01850953

Keywords

Versions (1)
  1. 4/17/19 4/17/19 -
Copyright Holder

Centre for Addiction and Mental Health Toronto

Uploaded on

April 17, 2019

DOI

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License

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

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

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

Smoker

Data type

boolean

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

Non-treatment seeking

Data type

boolean

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

Age

Data type

boolean

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

IQ

Data type

boolean

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

Nicotine dependency

Data type

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.
Description

Medical condition of patient

Data type

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.
Description

Medical condition of control participant

Data type

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
Description

Exclusion Criteria

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

Substance use

Data type

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
Description

Alcohol/drug abuse history

Data type

boolean

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

Use of opioids

Data type

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)
Description

Use of smoking cessation aids

Data type

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
Description

Pregnancy or nursing

Data type

boolean

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

Contraindications to varenicline

Data type

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
Description

Neurological illess

Data type

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.
Description

Medical condition

Data type

boolean

Alias
UMLS CUI [1]
C3843040
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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