ID

44289

Description

Smoking Study With Behavioral Therapy for Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00879177

Link

https://clinicaltrials.gov/show/NCT00879177

Keywords

Versions (2)
  1. 12/18/17 12/18/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cigarette Smoking NCT00879177

English

Eligibility Cigarette Smoking NCT00879177

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
regular smokers, with no period of abstinence exceeding 3 months in past year
Description

Tobacco use Regular | Abstinence Period Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0814442
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0332268
expired co of at least 8 ppm
Description

Expired carbon monoxide concentration

Data type

boolean

Alias
UMLS CUI [1]
C0429695
self-reported desire to stop smoking
Description

wishes to stop smoking

Data type

boolean

Alias
UMLS CUI [1]
C2203279
at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
resting systolic bp of 120-160 mmhg and/or diastolic bp of 80-100 mmhg but otherwise in good health (see exclusion criteria)
Description

Systolic blood pressure at rest | Diastolic blood pressure at rest | General health good

Data type

boolean

Alias
UMLS CUI [1]
C2039694
UMLS CUI [2]
C2183311
UMLS CUI [3]
C1277245
if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
Description

Antihypertensive Agents unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0442739
english speaking
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
Description

Smoking cessation therapy | Smoking cessation drug therapy

Data type

boolean

Alias
UMLS CUI [1]
C1095963
UMLS CUI [2]
C4075828
serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
Description

Disease; Serious | Disease Unstable | Myocardial Infarction | Malignant Neoplasms | Congestive heart failure | Kidney Failure | Cerebrovascular accident | Seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0035078
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0036572
evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ecg) abnormalities
Description

Allergic Reaction Varenicline | Medical contraindication Varenicline | Laboratory test result abnormal | ECG abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1569608
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1569608
UMLS CUI [3]
C0438215
UMLS CUI [4]
C0522055
breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
arm circumference of >42 cm, which precludes accurate bp monitoring
Description

Circumference of arm Excludes Blood pressure monitoring

Data type

boolean

Alias
UMLS CUI [1,1]
C2075184
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0026426
serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
Description

Mental disorders Serious | Schizophrenia | Psychotic Disorders | At risk for suicide | Substance Dependence | Exception Nicotine Dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0563664
UMLS CUI [5]
C0038580
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0028043
use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
Description

Tobacco use | Exception Cigarette | Smoking abstinence Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677453
UMLS CUI [3,1]
C0814442
UMLS CUI [3,2]
C0558080
ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
Description

Nicotine replacement therapy | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Mood Stabilizers | Naltrexone

Data type

boolean

Alias
UMLS CUI [1]
C1278444
UMLS CUI [2]
C0026457
UMLS CUI [3]
C0040615
UMLS CUI [4]
C4020582
UMLS CUI [5]
C0027360
in recovery for pathological gambling
Description

Recovery Pathological Gambling

Data type

boolean

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0030662
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Similar models

Eligibility Cigarette Smoking NCT00879177

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Tobacco use Regular | Abstinence Period Lacking
Item
regular smokers, with no period of abstinence exceeding 3 months in past year
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0814442 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Expired carbon monoxide concentration
Item
expired co of at least 8 ppm
boolean
C0429695 (UMLS CUI [1])
wishes to stop smoking
Item
self-reported desire to stop smoking
boolean
C2203279 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Systolic blood pressure at rest | Diastolic blood pressure at rest | General health good
Item
resting systolic bp of 120-160 mmhg and/or diastolic bp of 80-100 mmhg but otherwise in good health (see exclusion criteria)
boolean
C2039694 (UMLS CUI [1])
C2183311 (UMLS CUI [2])
C1277245 (UMLS CUI [3])
Antihypertensive Agents unchanged
Item
if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
boolean
C0003364 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Able to speak English Language
Item
english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Smoking cessation therapy | Smoking cessation drug therapy
Item
receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
boolean
C1095963 (UMLS CUI [1])
C4075828 (UMLS CUI [2])
Disease; Serious | Disease Unstable | Myocardial Infarction | Malignant Neoplasms | Congestive heart failure | Kidney Failure | Cerebrovascular accident | Seizures
Item
serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0035078 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0036572 (UMLS CUI [8])
Allergic Reaction Varenicline | Medical contraindication Varenicline | Laboratory test result abnormal | ECG abnormality
Item
evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ecg) abnormalities
boolean
C1527304 (UMLS CUI [1,1])
C1569608 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1569608 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
C0522055 (UMLS CUI [4])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Lacking
Item
breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Circumference of arm Excludes Blood pressure monitoring
Item
arm circumference of >42 cm, which precludes accurate bp monitoring
boolean
C2075184 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0026426 (UMLS CUI [1,3])
Mental disorders Serious | Schizophrenia | Psychotic Disorders | At risk for suicide | Substance Dependence | Exception Nicotine Dependence
Item
serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0563664 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0028043 (UMLS CUI [6,2])
Tobacco use | Exception Cigarette | Smoking abstinence Unwilling
Item
use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
boolean
C0543414 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0677453 (UMLS CUI [2,2])
C0814442 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Nicotine replacement therapy | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Mood Stabilizers | Naltrexone
Item
ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
boolean
C1278444 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C4020582 (UMLS CUI [4])
C0027360 (UMLS CUI [5])
Recovery Pathological Gambling
Item
in recovery for pathological gambling
boolean
C0237820 (UMLS CUI [1,1])
C0030662 (UMLS CUI [1,2])
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