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

Uploaded on

December 18, 2017

DOI

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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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