ID

17007

Beschrijving

Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1; ODM derived from: https://clinicaltrials.gov/show/NCT00131456

Link

https://clinicaltrials.gov/show/NCT00131456

Trefwoorden

Versies (1)
  1. 20-08-16 20-08-16 -
Geüploaded op

20 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depression NCT00131456

Engels

Eligibility Depression NCT00131456

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00131456
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
Beschrijving

Cannabis Dependence | Marijuana Abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0006870
UMLS CUI [2]
C0024809
currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the hamilton depression inventory
Beschrijving

Major Depressive Disorder | Dysthymic Disorder | Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0013415
UMLS CUI [3]
C0451203
clinically depressed for at least 3 months during a period of active marijuana use
Beschrijving

Depressed Clinical During Marijuana use Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344315
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0024810
UMLS CUI [1,5]
C1948053
women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. to confirm this, blood pregnancy tests will be repeated monthly. women will be provided a full explanation of the potential dangers of pregnancy while on the study. if a woman becomes pregnant, the study medication will be discontinued.
Beschrijving

Childbearing Potential Age pregnancy blood test | Childbearing Potential Age Contraceptive methods | pregnancy blood test Monthly | Pregnancy Investigational New Drug Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0850355
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0850355
UMLS CUI [3,2]
C0332177
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1444662
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
meets criteria for past manic or psychotic disorder, unless substance-related
Beschrijving

Manic Disorder | Psychotic Disorder | Manic Disorder Substance-related | Psychotic Disorder Substance-related

Datatype

boolean

Alias
UMLS CUI [1]
C0024713
UMLS CUI [2]
C0033975
UMLS CUI [3,1]
C0024713
UMLS CUI [3,2]
C0809981
UMLS CUI [4,1]
C0033975
UMLS CUI [4,2]
C0809981
history of a seizure disorder
Beschrijving

Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
individuals with chronic organic mental syndrome
Beschrijving

Organic mental disease chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029227
UMLS CUI [1,2]
C0205191
any significant risk for suicide based on current assessment and history of attempts
Beschrijving

At risk for suicide Significant | Suicide risk assessment | Suicide attempt

Datatype

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0558000
UMLS CUI [3]
C0038663
history of allergic reaction to either venlafaxine or ven-xr
Beschrijving

Venlafaxine allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0570764
unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (sbp>150, dbp >90, or a sitting quietly hr>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (<2x upper limit of normal are acceptable) or unstable diabetes
Beschrijving

physical illness Unstable Study Subject Participation Status Limited | Uncontrolled hypertension | Tachycardia Uncontrolled | Systolic Pressure | Diastolic blood pressure | heart rate while sitting | Acute hepatitis | Transaminases increased Mild chronic | Brittle diabetes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0039231
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
UMLS CUI [6]
C2029904
UMLS CUI [7]
C0267797
UMLS CUI [8,1]
C0438717
UMLS CUI [8,2]
C2945599
UMLS CUI [8,3]
C0205191
UMLS CUI [9]
C0342302
history of failure to respond to a previous adequate trial of venlafaxine of at least 300 mg. for at least a 6-week period
Beschrijving

venlafaxine Quantity Duration Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0078569
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C0205269
physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
Beschrijving

Drug Dependence Requirement detoxication | Nicotine Dependence

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510472
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0598281
UMLS CUI [2]
C0028043
currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
Beschrijving

Psychotropic Drugs prescribed | Therapeutic procedure Sleeplessness

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0917801
pregnant or breast-feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Depression NCT00131456

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00131456
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Cannabis Dependence | Marijuana Abuse
Item
meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
boolean
C0006870 (UMLS CUI [1])
C0024809 (UMLS CUI [2])
Major Depressive Disorder | Dysthymic Disorder | Hamilton rating scale for depression
Item
currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the hamilton depression inventory
boolean
C1269683 (UMLS CUI [1])
C0013415 (UMLS CUI [2])
C0451203 (UMLS CUI [3])
Depressed Clinical During Marijuana use Period
Item
clinically depressed for at least 3 months during a period of active marijuana use
boolean
C0344315 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0024810 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])
Childbearing Potential Age pregnancy blood test | Childbearing Potential Age Contraceptive methods | pregnancy blood test Monthly | Pregnancy Investigational New Drug Discontinued
Item
women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. to confirm this, blood pregnancy tests will be repeated monthly. women will be provided a full explanation of the potential dangers of pregnancy while on the study. if a woman becomes pregnant, the study medication will be discontinued.
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0850355 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0850355 (UMLS CUI [3,1])
C0332177 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Manic Disorder | Psychotic Disorder | Manic Disorder Substance-related | Psychotic Disorder Substance-related
Item
meets criteria for past manic or psychotic disorder, unless substance-related
boolean
C0024713 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0024713 (UMLS CUI [3,1])
C0809981 (UMLS CUI [3,2])
C0033975 (UMLS CUI [4,1])
C0809981 (UMLS CUI [4,2])
Epilepsy
Item
history of a seizure disorder
boolean
C0014544 (UMLS CUI [1])
Organic mental disease chronic
Item
individuals with chronic organic mental syndrome
boolean
C0029227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
At risk for suicide Significant | Suicide risk assessment | Suicide attempt
Item
any significant risk for suicide based on current assessment and history of attempts
boolean
C0563664 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0558000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Venlafaxine allergy
Item
history of allergic reaction to either venlafaxine or ven-xr
boolean
C0570764 (UMLS CUI [1])
physical illness Unstable Study Subject Participation Status Limited | Uncontrolled hypertension | Tachycardia Uncontrolled | Systolic Pressure | Diastolic blood pressure | heart rate while sitting | Acute hepatitis | Transaminases increased Mild chronic | Brittle diabetes
Item
unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (sbp>150, dbp >90, or a sitting quietly hr>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (<2x upper limit of normal are acceptable) or unstable diabetes
boolean
C0683323 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C1868885 (UMLS CUI [2])
C0039231 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
C2029904 (UMLS CUI [6])
C0267797 (UMLS CUI [7])
C0438717 (UMLS CUI [8,1])
C2945599 (UMLS CUI [8,2])
C0205191 (UMLS CUI [8,3])
C0342302 (UMLS CUI [9])
venlafaxine Quantity Duration Unresponsive to Treatment
Item
history of failure to respond to a previous adequate trial of venlafaxine of at least 300 mg. for at least a 6-week period
boolean
C0078569 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0205269 (UMLS CUI [1,4])
Drug Dependence Requirement detoxication | Nicotine Dependence
Item
physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
boolean
C1510472 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0598281 (UMLS CUI [1,3])
C0028043 (UMLS CUI [2])
Psychotropic Drugs prescribed | Therapeutic procedure Sleeplessness
Item
currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
boolean
C0033978 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0917801 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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