ID

32115

Beschreibung

Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00770237

Link

https://clinicaltrials.gov/show/NCT00770237

Stichworte

Versionen (1)
  1. 18.10.18 18.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00770237

Englisch

Eligibility Schizophrenia NCT00770237

1 Formulare  
Criteria
Beschreibung

Criteria

1. 18-64 year old males and females
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. smoking at least 10 cigarettes per day for at least 1 year
Beschreibung

Tobacco use Number of cigarettes per day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
3. urinary cotinine level ≥ 100 ng/ml (nicalert® reading ≥ 3)
Beschreibung

Urine cotinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278256
4. current dsm-iv diagnosis of schizophrenia and stable medication regimen (see above)
Beschreibung

Schizophrenia | Pharmacotherapy Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205360
5. medically healthy as determined by screening criteria
Beschreibung

Healthy Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0205476
inclusion criteria for healthy volunteers
Beschreibung

Inclusion criteria Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1708335
1. 18-64 year old males and females
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. smoking at least 10 cigarettes per day for at least 1 year
Beschreibung

Tobacco use Number of cigarettes per day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
3. urinary cotinine level ≥ 100 ng/ml (nicalert® reading ≥ 3)
Beschreibung

Urine cotinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278256
4. medically and psychologically healthy as determined by screening criteria
Beschreibung

Healthy Medical | Healthy Psychological

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0205476
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0205486
exclusion criteria for schizophrenia patients
Beschreibung

Exclusion Criteria Schizophrenia Patients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C0030705
1. current interest in reducing or quitting tobacco use
Beschreibung

Interested Smoking Reduction | Interested Cessation of smoking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543488
UMLS CUI [1,2]
C4505208
UMLS CUI [2,1]
C0543488
UMLS CUI [2,2]
C0085134
2. treatment for tobacco dependence in the past 3 months
Beschreibung

Therapy Tobacco Dependence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0040332
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
Beschreibung

Nicotine Replacement Products | Bupropion | varenicline

Datentyp

boolean

Alias
UMLS CUI [1]
C3179143
UMLS CUI [2]
C0085208
UMLS CUI [3]
C1569608
4. consumption of more than 15 alcoholic drinks per week during the past month
Beschreibung

Alcohol consumption units/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
5. use of any illicit drug more than twice per week during the past month
Beschreibung

Illicit medication use times/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0456698
6. current use of any medication that would interfere with the protocol in the opinion of mai (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
Beschreibung

Pharmaceutical Preparation Interferes with Study Protocol | Antidepressive Agents | Antipsychotic Agents Generation First | Mood Stabilizers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0079411
UMLS CUI [3,3]
C0205435
UMLS CUI [4]
C4020582
7. under the influence of a drug or alcohol at experimental sessions
Beschreibung

Substance use Session Experimental

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237123
UMLS CUI [1,2]
C1883016
UMLS CUI [1,3]
C1517586
8. pregnant, nursing, or become pregnant during the study
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
exclusion criteria for healthy volunteers
Beschreibung

Exclusion Criteria Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1708335
1. current interest in reducing or quitting tobacco use
Beschreibung

Interested Smoking Reduction | Interested Cessation of smoking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543488
UMLS CUI [1,2]
C4505208
UMLS CUI [2,1]
C0543488
UMLS CUI [2,2]
C0085134
2. treatment for tobacco dependence in the past 3 months
Beschreibung

Therapy Tobacco Dependence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0040332
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
Beschreibung

Nicotine Replacement Products | Bupropion | varenicline

Datentyp

boolean

Alias
UMLS CUI [1]
C3179143
UMLS CUI [2]
C0085208
UMLS CUI [3]
C1569608
4. consumption of more than 15 alcoholic drinks per week during the past month
Beschreibung

Alcohol consumption units/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
5. use of any illicit drug more than twice per week during the past month
Beschreibung

Illicit medication use times/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0456698
6. current use of any medication that would interfere with the protocol in the opinion of mai (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
Beschreibung

Pharmaceutical Preparation Interferes with Study Protocol | Antidepressive Agents | Antipsychotic Agents | Mood Stabilizers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0040615
UMLS CUI [4]
C4020582
7. under the influence of a drug or alcohol at experimental sessions
Beschreibung

Substance use Session Experimental

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237123
UMLS CUI [1,2]
C1883016
UMLS CUI [1,3]
C1517586
8. pregnant, nursing, or become pregnant during the study
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Schizophrenia NCT00770237

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
1. 18-64 year old males and females
boolean
C0001779 (UMLS CUI [1])
Tobacco use Number of cigarettes per day
Item
2. smoking at least 10 cigarettes per day for at least 1 year
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Urine cotinine measurement
Item
3. urinary cotinine level ≥ 100 ng/ml (nicalert® reading ≥ 3)
boolean
C1278256 (UMLS CUI [1])
Schizophrenia | Pharmacotherapy Stable
Item
4. current dsm-iv diagnosis of schizophrenia and stable medication regimen (see above)
boolean
C0036341 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Healthy Medical
Item
5. medically healthy as determined by screening criteria
boolean
C3898900 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Inclusion criteria Healthy Volunteers
Item
inclusion criteria for healthy volunteers
boolean
C1512693 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Age
Item
1. 18-64 year old males and females
boolean
C0001779 (UMLS CUI [1])
Tobacco use Number of cigarettes per day
Item
2. smoking at least 10 cigarettes per day for at least 1 year
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Urine cotinine measurement
Item
3. urinary cotinine level ≥ 100 ng/ml (nicalert® reading ≥ 3)
boolean
C1278256 (UMLS CUI [1])
Healthy Medical | Healthy Psychological
Item
4. medically and psychologically healthy as determined by screening criteria
boolean
C3898900 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0205486 (UMLS CUI [2,2])
Exclusion Criteria Schizophrenia Patients
Item
exclusion criteria for schizophrenia patients
boolean
C0680251 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
Interested Smoking Reduction | Interested Cessation of smoking
Item
1. current interest in reducing or quitting tobacco use
boolean
C0543488 (UMLS CUI [1,1])
C4505208 (UMLS CUI [1,2])
C0543488 (UMLS CUI [2,1])
C0085134 (UMLS CUI [2,2])
Therapy Tobacco Dependence
Item
2. treatment for tobacco dependence in the past 3 months
boolean
C0087111 (UMLS CUI [1,1])
C0040332 (UMLS CUI [1,2])
Nicotine Replacement Products | Bupropion | varenicline
Item
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
boolean
C3179143 (UMLS CUI [1])
C0085208 (UMLS CUI [2])
C1569608 (UMLS CUI [3])
Alcohol consumption units/week
Item
4. consumption of more than 15 alcoholic drinks per week during the past month
boolean
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Illicit medication use times/week
Item
5. use of any illicit drug more than twice per week during the past month
boolean
C0281875 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
Pharmaceutical Preparation Interferes with Study Protocol | Antidepressive Agents | Antipsychotic Agents Generation First | Mood Stabilizers
Item
6. current use of any medication that would interfere with the protocol in the opinion of mai (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C0079411 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C4020582 (UMLS CUI [4])
Substance use Session Experimental
Item
7. under the influence of a drug or alcohol at experimental sessions
boolean
C0237123 (UMLS CUI [1,1])
C1883016 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
8. pregnant, nursing, or become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Exclusion Criteria Healthy Volunteers
Item
exclusion criteria for healthy volunteers
boolean
C0680251 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Interested Smoking Reduction | Interested Cessation of smoking
Item
1. current interest in reducing or quitting tobacco use
boolean
C0543488 (UMLS CUI [1,1])
C4505208 (UMLS CUI [1,2])
C0543488 (UMLS CUI [2,1])
C0085134 (UMLS CUI [2,2])
Therapy Tobacco Dependence
Item
2. treatment for tobacco dependence in the past 3 months
boolean
C0087111 (UMLS CUI [1,1])
C0040332 (UMLS CUI [1,2])
Nicotine Replacement Products | Bupropion | varenicline
Item
3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
boolean
C3179143 (UMLS CUI [1])
C0085208 (UMLS CUI [2])
C1569608 (UMLS CUI [3])
Alcohol consumption units/week
Item
4. consumption of more than 15 alcoholic drinks per week during the past month
boolean
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Illicit medication use times/week
Item
5. use of any illicit drug more than twice per week during the past month
boolean
C0281875 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
Pharmaceutical Preparation Interferes with Study Protocol | Antidepressive Agents | Antipsychotic Agents | Mood Stabilizers
Item
6. current use of any medication that would interfere with the protocol in the opinion of mai (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C4020582 (UMLS CUI [4])
Substance use Session Experimental
Item
7. under the influence of a drug or alcohol at experimental sessions
boolean
C0237123 (UMLS CUI [1,1])
C1883016 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
8. pregnant, nursing, or become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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