ID

45728

Beschreibung

Principal Investigator: Edythe London, Ph.D, Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA MeSH: Substance-Related Disorders,Methamphetamine,Sex,Ethnic Groups https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001198 This study included two groups of subjects, methamphetamine-dependent and healthy control participants, with the purpose of characterizing brain structure and cognition during the first month of abstinence from methamphetamine. Participants were able to participate in one or both phases of the study. Methamphetamine abusers were held as inpatients and abstained from methamphetamine use during the entirety of the study. Phase I covered the 1st week of abstinence and Phase II covered the next 3-4 weeks of abstinence. Control subjects participated as outpatients at timeframes which corresponded to the assessments taken of methamphetamine users. The following outlines the procedures in more detail. After initial telephone screening, in-person screening and recruitment procedures took place at the UCLA Neuropsychiatric Institute. Each methamphetamine abuser subject entered the study after completing an interview and questionnaires on drug use history, and providing a positive urine test for methamphetamine. The evaluation included a psychiatric diagnostic interview according to the Structured Clinical Inventory for DSM-IV (SCID-IV), a medical history and physical examination, blood tests [including a complete chemistry panel, hepatic panel, and tests for hepatitis-C and HIV]. Urine samples were also taken for drug screening of illicit drugs, and to test for pregnancy (female subjects). The methamphetamine abusers were then admitted to the General Clinical Research Center (CRC) and participated on a residential basis, where they were administered daily questionnaires about drug craving, withdrawal and mood. The current study makes available phenotype and genotype data, and interested investigators may contact the principal investigator regarding potential sharing of fMRI data.

Link

dbGaP-study=phs001198

Stichworte

Versionen (1)
  1. 25.05.23 25.05.23 - Chiara Middel
Rechteinhaber

Edythe London, Ph.D, Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA

Hochgeladen am

25. Mai 2023

DOI

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Creative Commons BY 4.0
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dbGaP phs001198 Early Methamphetamine Abstinence: fMRI and Brain Function

Englisch

Eligibility Criteria

6 Formulare  
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion Criteria:*
Beschreibung

Elig.phs001198.v1.p1.1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
*Age and Gender:* 21 to 50 years of age, both genders.
Beschreibung

Elig.phs001198.v1.p1.2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C0079399
*Handedness:* Right-handedness (score >20 on a modified Edinburgh Handedness Test).
Beschreibung

Elig.phs001198.v1.p1.3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205090
UMLS CUI [1,2]
C0023114
UMLS CUI [1,3]
C2737250
*Exclusion Criteria:*
Beschreibung

Elig.phs001198.v1.p1.4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
*Psychiatric disease:* Current Axis I diagnosis (according to DSM-IV criteria), except for the diagnosis of methamphetamine dependence (methamphetamine abuser group only) and nicotine dependence (both groups).
Beschreibung

Elig.phs001198.v1.p1.5

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0270287
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0025611
UMLS CUI [1,5]
C0038580
UMLS CUI [1,6]
C0028043
*History of Drug Abuse:* Potential participants with current dependence on any drug (other than nicotine, or for the methamphetamine group, methamphetamine) were excluded.
Beschreibung

Elig.phs001198.v1.p1.6

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299544
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0038580
UMLS CUI [1,4]
C1705847
UMLS CUI [1,5]
C0028043
UMLS CUI [1,6]
C0002658
UMLS CUI [1,7]
C0038580
*Medications:* Evidence of taking psychotropic medications (other than methamphetamine for the methamphetamine abuser group and nicotine for both groups) was exclusionary for both groups.
Beschreibung

Elig.phs001198.v1.p1.7

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0033978
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C0025611
UMLS CUI [1,7]
C0028040
*CNS Disease:* Structural brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), history of other neurological disease, including stroke or head trauma (defined as loss of consciousness > 30 min or requiring hospitalization).
Beschreibung

Elig.phs001198.v1.p1.8

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0851391
UMLS CUI [1,3]
C0007820
UMLS CUI [1,4]
C0009450
UMLS CUI [1,5]
C0262926
UMLS CUI [1,6]
C0018674
UMLS CUI [1,7]
C0559159
*Cardiovascular Disease:* Advanced coronary artery disease, endocarditis or other cardiac disease likely to result in cerebral embolism.
Beschreibung

Elig.phs001198.v1.p1.9

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0679246
UMLS CUI [1,3]
C1956346
UMLS CUI [1,4]
C0014118
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C0018799
UMLS CUI [1,7]
C1444708
UMLS CUI [1,8]
C1274040
UMLS CUI [1,9]
C0007780
*Pulmonary Disease:* Significant obstructive pulmonary disease or tuberculosis.
Beschreibung

Elig.phs001198.v1.p1.10

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0600260
UMLS CUI [1,4]
C0041296
*Systemic Disease:* Endocrinopathies, renal or hepatic failure, or autoimmune disease involving the CNS.
Beschreibung

Elig.phs001198.v1.p1.11

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0014130
UMLS CUI [1,3]
C0035078
UMLS CUI [1,4]
C0085605
UMLS CUI [1,5]
C0004364
UMLS CUI [1,6]
C0449389
*Claustrophobia:* Subjects were questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who reported such problems were excluded.
Beschreibung

Elig.phs001198.v1.p1.12

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008909
*Pregnancy:* Pregnancy, possible pregnancy, or failure to indicate the use of reliable birth control precautions. A pregnancy test was administered to each female participant before starting each of the 2 phases of the study. Subjects must have agreed to use an effective form of birth control between participation in Phase I and Phase II of the study. The only acceptable methods of birth control were: 1) oral contraceptive; 2) Depo-Provera injection; 3) intrauterine device; 4) diaphragm with contraceptive jelly; 5) condom with contraceptive jelly, foam, or sponge; 6) tubal ligation or hysterectomy; 7) abstinence from heterosexual intercourse.
Beschreibung

Elig.phs001198.v1.p1.13

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0425965
UMLS CUI [1,3]
C0680095
UMLS CUI [1,4]
C1524063
UMLS CUI [1,5]
C0700589
UMLS CUI [2,1]
C0032976
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C2603343
UMLS CUI [2,4]
C0205390
UMLS CUI [3,1]
C1511481
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0489652
UMLS CUI [4,1]
C1879533
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0009905
UMLS CUI [4,4]
C3843416
UMLS CUI [4,5]
C0021900
UMLS CUI [4,6]
C0009653
UMLS CUI [4,7]
C0020699
UMLS CUI [4,8]
C0589114
UMLS CUI [4,9]
C0004764
UMLS CUI [4,10]
C0087145
UMLS CUI [4,11]
C0036899
*HIV*: Subjects who were HIV-seropositive were excluded because HIV infection and the development of AIDS produces confounding alterations in brain activity that are dependent on the stage of AIDS.
Beschreibung

Elig.phs001198.v1.p1.14

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019699
We excluded any subject whose body contained a ferromagnetic implanted device that might produce a safety hazard during fMRI. We used as guidelines, the manual, Magnetic Resonance: Bioeffects, Safety, and Patient Management45 supplemented by the current information published on the International MR Safety Web Site: http://kanal.arad.upmc.edu/mrsafety.html.
Beschreibung

Elig.phs001198.v1.p1.15

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C2911688
UMLS CUI [1,3]
C0376335
*Vision:* Colorblindness, which could affect performance on the Stroop Task.
Beschreibung

Elig.phs001198.v1.p1.16

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242225
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0597198
*Language:* Lack of fluency in English was exclusionary because it would interfere with performance of psychological tests and filling out questionnaires used in the study. The consent form, all questionnaires and instructions were administered in English.
Beschreibung

Elig.phs001198.v1.p1.17

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0586740
UMLS CUI [1,4]
C0376245
UMLS CUI [1,5]
C0521102
UMLS CUI [1,6]
C0034394
UMLS CUI [1,7]
C0033905
UMLS CUI [2,1]
C1442085
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C0034394
UMLS CUI [2,4]
C0376245
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Ähnliche Modelle

Eligibility Criteria

6 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001198.v1.p1.1
Item
*Inclusion Criteria:*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs001198.v1.p1.2
Item
*Age and Gender:* 21 to 50 years of age, both genders.
boolean
C0001779 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
Elig.phs001198.v1.p1.3
Item
*Handedness:* Right-handedness (score >20 on a modified Edinburgh Handedness Test).
boolean
C0205090 (UMLS CUI [1,1])
C0023114 (UMLS CUI [1,2])
C2737250 (UMLS CUI [1,3])
Elig.phs001198.v1.p1.4
Item
*Exclusion Criteria:*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs001198.v1.p1.5
Item
*Psychiatric disease:* Current Axis I diagnosis (according to DSM-IV criteria), except for the diagnosis of methamphetamine dependence (methamphetamine abuser group only) and nicotine dependence (both groups).
boolean
C0004936 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0025611 (UMLS CUI [1,4])
C0038580 (UMLS CUI [1,5])
C0028043 (UMLS CUI [1,6])
Elig.phs001198.v1.p1.6
Item
*History of Drug Abuse:* Potential participants with current dependence on any drug (other than nicotine, or for the methamphetamine group, methamphetamine) were excluded.
boolean
C1299544 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0038580 (UMLS CUI [1,3])
C1705847 (UMLS CUI [1,4])
C0028043 (UMLS CUI [1,5])
C0002658 (UMLS CUI [1,6])
C0038580 (UMLS CUI [1,7])
Elig.phs001198.v1.p1.7
Item
*Medications:* Evidence of taking psychotropic medications (other than methamphetamine for the methamphetamine abuser group and nicotine for both groups) was exclusionary for both groups.
boolean
C0013227 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0033978 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C0025611 (UMLS CUI [1,6])
C0028040 (UMLS CUI [1,7])
Elig.phs001198.v1.p1.8
Item
*CNS Disease:* Structural brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), history of other neurological disease, including stroke or head trauma (defined as loss of consciousness > 30 min or requiring hospitalization).
boolean
C0007682 (UMLS CUI [1,1])
C0851391 (UMLS CUI [1,2])
C0007820 (UMLS CUI [1,3])
C0009450 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
C0018674 (UMLS CUI [1,6])
C0559159 (UMLS CUI [1,7])
Elig.phs001198.v1.p1.9
Item
*Cardiovascular Disease:* Advanced coronary artery disease, endocarditis or other cardiac disease likely to result in cerebral embolism.
boolean
C0007222 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
C0014118 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0018799 (UMLS CUI [1,6])
C1444708 (UMLS CUI [1,7])
C1274040 (UMLS CUI [1,8])
C0007780 (UMLS CUI [1,9])
Elig.phs001198.v1.p1.10
Item
*Pulmonary Disease:* Significant obstructive pulmonary disease or tuberculosis.
boolean
C0024115 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0600260 (UMLS CUI [1,3])
C0041296 (UMLS CUI [1,4])
Elig.phs001198.v1.p1.11
Item
*Systemic Disease:* Endocrinopathies, renal or hepatic failure, or autoimmune disease involving the CNS.
boolean
C0442893 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0035078 (UMLS CUI [1,3])
C0085605 (UMLS CUI [1,4])
C0004364 (UMLS CUI [1,5])
C0449389 (UMLS CUI [1,6])
Elig.phs001198.v1.p1.12
Item
*Claustrophobia:* Subjects were questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who reported such problems were excluded.
boolean
C0008909 (UMLS CUI [1,1])
Elig.phs001198.v1.p1.13
Item
*Pregnancy:* Pregnancy, possible pregnancy, or failure to indicate the use of reliable birth control precautions. A pregnancy test was administered to each female participant before starting each of the 2 phases of the study. Subjects must have agreed to use an effective form of birth control between participation in Phase I and Phase II of the study. The only acceptable methods of birth control were: 1) oral contraceptive; 2) Depo-Provera injection; 3) intrauterine device; 4) diaphragm with contraceptive jelly; 5) condom with contraceptive jelly, foam, or sponge; 6) tubal ligation or hysterectomy; 7) abstinence from heterosexual intercourse.
boolean
C0032961 (UMLS CUI [1,1])
C0425965 (UMLS CUI [1,2])
C0680095 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
C0700589 (UMLS CUI [1,5])
C0032976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C0205390 (UMLS CUI [2,4])
C1511481 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0489652 (UMLS CUI [3,4])
C1879533 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [4,3])
C3843416 (UMLS CUI [4,4])
C0021900 (UMLS CUI [4,5])
C0009653 (UMLS CUI [4,6])
C0020699 (UMLS CUI [4,7])
C0589114 (UMLS CUI [4,8])
C0004764 (UMLS CUI [4,9])
C0087145 (UMLS CUI [4,10])
C0036899 (UMLS CUI [4,11])
Elig.phs001198.v1.p1.14
Item
*HIV*: Subjects who were HIV-seropositive were excluded because HIV infection and the development of AIDS produces confounding alterations in brain activity that are dependent on the stage of AIDS.
boolean
C0019699 (UMLS CUI [1,1])
Elig.phs001198.v1.p1.15
Item
We excluded any subject whose body contained a ferromagnetic implanted device that might produce a safety hazard during fMRI. We used as guidelines, the manual, Magnetic Resonance: Bioeffects, Safety, and Patient Management45 supplemented by the current information published on the International MR Safety Web Site: http://kanal.arad.upmc.edu/mrsafety.html.
boolean
C3693688 (UMLS CUI [1,1])
C2911688 (UMLS CUI [1,2])
C0376335 (UMLS CUI [1,3])
Elig.phs001198.v1.p1.16
Item
*Vision:* Colorblindness, which could affect performance on the Stroop Task.
boolean
C0242225 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0597198 (UMLS CUI [1,3])
Elig.phs001198.v1.p1.17
Item
*Language:* Lack of fluency in English was exclusionary because it would interfere with performance of psychological tests and filling out questionnaires used in the study. The consent form, all questionnaires and instructions were administered in English.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0586740 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C0521102 (UMLS CUI [1,5])
C0034394 (UMLS CUI [1,6])
C0033905 (UMLS CUI [1,7])
C1442085 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
C0376245 (UMLS CUI [2,4])
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