ID

45732

Descripción

Principal Investigator: Edythe London, PhD, Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA MeSH: Sex/Gender Identity,Ethnic Groups,Age Groups,Drug Users https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001195 The Study to Assess the Cardiovascular, Cognitive, and Subjective Effects of Atomoxetine in Combination with Intravenous Methamphetamine started in 2007 and ended in 2011. It was a small pilot study that included methamphetamine abusing individuals and healthy control participants aged 18-50 years. Participants who qualified over the telephone were scheduled to visit the London Laboratory at the UCLA Semel Institute for Neuroscience and Human Behavior for the In-Person Screening Phase. The screening procedures, usually scheduled over two visits, determined if participants were eligible to complete the subsequent study visits. Both groups completed identical screening procedures, including a SCID diagnostic interview to rule out any major psychiatric disorders. Methamphetamine users also answered questionnaires specific to their drug use. Urine toxicology for marijuana, opiates, cocaine, methamphetamine, and benzodiazepines were monitored at the beginning and throughout the study. Additionally, participants had blood samples to test for Rapid Plasma Reagin (exposure to syphilis), purified protein derivative (PPD), HIV and Hepatitis-C (HCV). Positive test results were relayed by a study physician and resulted in termination from continuing in the study. The inpatient portion of the study lasted a total of 24 days. To confirm compliance with abstinence from illicit and prescription drug use for the duration of the study, urine and breath alcohol testing was performed for both inpatient (methamphetamine users) and outpatient (healthy control) groups. Each subject was randomized to receive either atomoxetine (80 mg daily) or placebo. During inpatient days of the study, a study physician oversaw research subjects daily and experimental procedures were conducted in the General Clinical Research Center (GCRC). During drug administration sessions, heart rate and blood pressure were assessed at frequent intervals. Experimental sessions lasted around three hours and were conducted at approximately the same time of day for a given participant. Lunch was provided to participants at 11:30am with the prohibition of caffeine on study days involving methamphetamine administration. Participants were provided with smoke breaks as needed to assure that acute nicotine withdrawal did not negatively impact performance on cognitive testing. The following outlines the day to day procedures for a methamphetamine inpatient: *Phase I Inpatient Study* (*15 days total*) *Days 1-3:* On the day of admission, participants received blood tests and an EKG in order to determine that they had no occult medical conditions which would make their participation in the study medically contraindicated. A three day washout period was provided at the beginning of the study to establish an appropriate methamphetamine-free baseline for testing. *Days 4-6:* Participants completed cognitive test batteries to assess inhibitory control including self-report measures and cognitive testing, as well as up to three MRI scanning sessions. *Day 7:* On day 7, at 9AM and 1PM, participants received methamphetamine in a single-blinded condition. It was administered as two IV infusions of 15mg separated by a 60min break. The total dose of IV methamphetamine was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in the absence of study medication. *Day 8:* On day 8 we evaluated the safety and residual effects of the methamphetamine administered on the previous day. *Days 9-10:* After demonstrating medical and psychiatric stability of the initial methamphetamine infusion, participants were then randomized to receive placebo or atomoxetine (0 or 40mg) under double-blind conditions, which would be given at 8AM on both study days. *Days 11-12:* On days 11 and 12, participants remained in the GCRC and took two doses of test compound atomoxetine (0 or 40mg) at 8AM and 8PM. On the morning of day 12, participants completed a series of cognitive testing. *Day 13:* On day 13, participants remained in the GCRC, and took two doses of the test compound atomoxetine (0 or 40mg) at 8AM and 8PM. At 9AM and noon, they received methamphetamine under double-blind conditions administered non-contingently as two infusions of 0 or 15mg by IV (intravenously), with each infusion separated by 60min. The total dose of IV methamphetamine that each participant received was 30mg. As before, participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. *Day 14:* On day 14 at 8AM, participants received their final dosing of the first test compound (atomoxetine 0 or 40mg). At 9AM and 1PM, participants selected between methamphetamine infusion or money using double-blind conditions in a multiple-choice self-administration paradigm. Participants were able to take up to two infusions of 0 or 15mg of methamphetamine, separated by 60min. The total dose of IV methamphetamine that each participant received on day 14 was 30mg. Participants were clinically evaluated by continuous cardiac telemetry, serial EKG and measurement of vital signs, during and after infusions, in order to determine the medical safety of methamphetamine infusion in those participants receiving study medication. At 5pm on day 14 discharge laboratory studies were drawn. *Day 15:* On day 15, a final EKG was performed as well as a review of discharge laboratory studies, including review of the EKG and continued medical and psychiatric stability. Upon clearance from a physician, participants were discharged on day 15. Participants spent at least 2 weeks (14 days) out of the hospital prior to returning to the UCLA GCRC for inpatient Phase II. *Phase II Inpatient Study* *(9 days total)* *Day 1-2:* On the day of re-admission, participants received blood tests and an EKG. A two day washout period was provided at the beginning of the study to establish an appropriate methamphetamine free condition for safe administration of the second test compound condition. *Days 3-4:* On days 3 and 4, given medical stability, participants were then switched to the opposite test compound (atomoxetine 0 or 40mg) under double-blind conditions, in the same manner as in Days 9-10 in Phase I. *Days 5-6:* Same procedure as in Days 11-12 in Phase I but with opposite medication condition. *Day 7:* Same procedure as in Day13 in Phase I but with opposite medication condition. *Day 8:* Same procedure as in Day14 in Phase I but with opposite medication condition. bDay 9:/b Same procedure as in Day14 in Phase I but with opposite medication condition.br/ For healthy control participants, the study consisted of 30 days or fewer of out-patient testing. Healthy control participants had an extensive screening, including a history and physical exam performed by a study physician, an EKG, and laboratory studies performed to assess for medical or psychiatric conditions. Control participants meeting criteria were invited back to UCLA to undergo cognitive testing, and some participants received fMRI scans. Participants were required to refrain from illicit and prescription drug use for the duration of the study, which was confirmed with urine toxicology and breath alcohol level testing on examination days. Caffeine was restricted on study days for least 2 hours prior to cognitive testing and MRI scans. Participants were permitted to drink their normal daily intake of caffeine, given the caveat above. On study days, cigarette smoking was permitted to match conditions used with methamphetamine users. The incorporation of smoke breaks during the test day assured that acute nicotine withdrawal did not negatively impact performance on cognitive tests or neuroimaging. The following outlines procedures for healthy control participants: For normal controls, participation involved one day of outpatient screening, and one day of baseline cognitive testing and possible MRI scans. After these procedures were completed, participants were randomized to the first test compound (atomoxetine 40mg or placebo), to be taken once daily in the morning for 2 days. It was then increased to twice daily for the next 3 days, followed by a final dose (40mg or placebo) on the sixth day of study medication. Participants were also asked to bring their pill packages to assess compliance with the study medication. Additionally, control participants completed a series of repeated-measures cognitive testing (on placebo or atomoxetine, respectively) and possibly two fMRI sessions (separated by a short break). After at least a four-day washout period, control participants were instructed to start the opposite test compound (atomoxetine 40mg or placebo), again to be taken once daily in the morning for two days, then twice daily for 3 days, reaching the final dose (40mg or placebo) of the second test compound in the morning. Participants were again asked to bring their pill packages to assess compliance and had blood drawn to assess atomoxetine levels. Control participants then completed another series of cognitive testing and fMRI testing sessions. They were subsequently discharged from the study. Normal control participants returned two weeks after completion of both study phases in order to complete assessments to their physical and psychological status following treatment.

Link

dbGaP-study=phs001195

Palabras clave

Versiones (1)
  1. 2023-06-01 2023-06-01 - Chiara Middel
Titular de derechos de autor

Edythe London, PhD, Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA

Subido en

1 juni 2023

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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dbGaP phs001195 A Study to Assess the Cardiovascular, Cognitive, and Subjective Effects of Atomoxetine in Combination with Intravenous Methamphetamine

Inglés

Eligibility Criteria

6 formularios  
Inclusion and exclusion criteria
Descripción

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion Criteria:* <ol type="1">
Descripción

Elig.phs001195.v1.p1.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
Be fluently English-speaking volunteers.
Descripción

Elig.phs001195.v1.p1.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0680274
Be between 18 and 50 years of age.
Descripción

Elig.phs001195.v1.p1.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
Descripción

Elig.phs001195.v1.p1.4

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1576874
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C2364293
UMLS CUI [3,2]
C0600109
UMLS CUI [3,3]
C2732579
If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized. <ol type="a">
Descripción

Elig.phs001195.v1.p1.5

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0680240
UMLS CUI [1,4]
C0700589
UMLS CUI [1,5]
C0232970
UMLS CUI [1,6]
C0020699
UMLS CUI [1,7]
C0015787
oral contraceptives
Descripción

Elig.phs001195.v1.p1.6

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009905
barrier (diaphragm or condom) with spermicide, or condom only
Descripción

Elig.phs001195.v1.p1.7

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037862
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0679782
intrauterine progesterone, or non-hormonal contraceptive system
Descripción

Elig.phs001195.v1.p1.8

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021900
levonorgestrel implant
Descripción

Elig.phs001195.v1.p1.9

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1253292
medroxyprogesterone acetate contraceptive injection
Descripción

Elig.phs001195.v1.p1.10

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2092240
complete abstinence from sexual intercourse
Descripción

Elig.phs001195.v1.p1.11

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036899
Control Subjects: <ol type="a">
Descripción

Elig.phs001195.v1.p1.12

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009932
Must have vital signs as follows during two visits prior to medication administration: resting pulse between 50 and 90 bpm, blood pressures between 105-150mm Hg systolic and 45-90mm Hg diastolic.
Descripción

Elig.phs001195.v1.p1.13

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205448
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0013227
UMLS CUI [1,6]
C0808070
UMLS CUI [2,1]
C1704788
UMLS CUI [2,2]
C0232117
UMLS CUI [2,3]
C0005823
Have an ECG performed that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
Descripción

Elig.phs001195.v1.p1.14

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0232202
UMLS CUI [1,3]
C0205307
UMLS CUI [1,4]
C0232217
UMLS CUI [1,5]
C1298908
UMLS CUI [1,6]
C2985739
UMLS CUI [1,7]
C0003811
Agree to abstain from any and all substances of abuse during the study, evidenced by toxicology-negative urine each day prior to study procedures.
Descripción

Elig.phs001195.v1.p1.15

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0013146
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
UMLS CUI [1,6]
C0852616
UMLS CUI [1,7]
C1513916
UMLS CUI [1,8]
C1278212
UMLS CUI [1,9]
C0332152
UMLS CUI [1,10]
C2347804
Methamphetamine Subjects: <ol type="a">
Descripción

Elig.phs001195.v1.p1.16

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025611
UMLS CUI [1,2]
C0681850
Must meet DSM-IV criteria for methamphetamine abuse or dependence.
Descripción

Elig.phs001195.v1.p1.17

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C0025611
UMLS CUI [1,5]
C0038586
UMLS CUI [1,6]
C0038580
Have smoked or injected methamphetamine for more than two years.
Descripción

Elig.phs001195.v1.p1.18

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1608325
UMLS CUI [1,2]
C0683092
UMLS CUI [1,3]
C0025611
UMLS CUI [1,4]
C3844700
UMLS CUI [1,5]
C0439234
Produce a methamphetamine-positive urine prior to study entry.
Descripción

Elig.phs001195.v1.p1.19

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0025611
Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150mm Hg systolic and 45-90mm Hg diastolic. Note: Methamphetamine Abusing participants may present with elevated vital signs during the intake screening phase as a result of methamphetamine intoxication or anxiety and elevated vital signs may occur after inclusion to the study prior to administration or Methamphetamine or study compound. Participants must have vital signs within the aforementioned range on two timepoints (i.e., morning or night vital collection) during two consecutive days prior to randomization or participation was terminated.
Descripción

Elig.phs001195.v1.p1.20

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1704788
UMLS CUI [1,3]
C1821417
UMLS CUI [1,4]
C0005823
UMLS CUI [2,1]
C1997894
UMLS CUI [2,2]
C0025611
UMLS CUI [2,3]
C0038586
UMLS CUI [2,4]
C0518766
UMLS CUI [2,5]
C3163633
UMLS CUI [2,6]
C0347984
UMLS CUI [2,7]
C1710477
UMLS CUI [2,8]
C0205390
UMLS CUI [2,9]
C1274040
UMLS CUI [2,10]
C0025611
UMLS CUI [2,11]
C0728899
UMLS CUI [2,12]
C0003467
UMLS CUI [3,1]
C1997894
UMLS CUI [3,2]
C0025611
UMLS CUI [3,3]
C0038586
UMLS CUI [3,4]
C0518766
UMLS CUI [3,5]
C3163633
UMLS CUI [3,6]
C0231290
UMLS CUI [3,7]
C1512693
UMLS CUI [3,8]
C0332152
UMLS CUI [3,9]
C1533734
UMLS CUI [3,10]
C0025611
UMLS CUI [3,11]
C0304229
UMLS CUI [4,1]
C0518766
UMLS CUI [4,2]
C0332285
UMLS CUI [4,3]
C1514721
UMLS CUI [4,4]
C1524031
UMLS CUI [4,5]
C0205448
UMLS CUI [4,6]
C2348792
UMLS CUI [4,7]
C0332152
UMLS CUI [4,8]
C0034656
Have an ECG performed that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
Descripción

Elig.phs001195.v1.p1.21

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0232202
UMLS CUI [1,3]
C0205307
UMLS CUI [1,4]
C0232217
UMLS CUI [1,5]
C1298908
UMLS CUI [1,6]
C2985739
UMLS CUI [1,7]
C0003811
Agree to abstain from MA during the study, evidenced by a MA-negative urine each morning of the study.
Descripción

Elig.phs001195.v1.p1.22

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0025611
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
UMLS CUI [1,6]
C1513916
UMLS CUI [1,7]
C1278212
UMLS CUI [1,8]
C0332173
UMLS CUI [1,9]
C0332170
*Exclusion Criteria:* <ol type="1">
Descripción

Elig.phs001195.v1.p1.23

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
A current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
Descripción

Elig.phs001195.v1.p1.24

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1444635
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0036572
UMLS CUI [1,4]
C0014544
UMLS CUI [1,5]
C0205263
UMLS CUI [1,6]
C0036572
UMLS CUI [1,7]
C0009952
UMLS CUI [1,8]
C2317090
A history of head trauma that resulted in neurological sequelae (e.g., with loss of consciousness [LOC] &gt;15 minutes, or that required hospitalization. Also, individuals with 3 or more head injuries with LOC &gt;5 minutes will be excluded).
Descripción

Elig.phs001195.v1.p1.25

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018674
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0027765
UMLS CUI [1,5]
C0243088
UMLS CUI [1,6]
C0449238
UMLS CUI [1,7]
C0041657
UMLS CUI [1,8]
C0019993
Evidence of clinically significant heart disease, hypertension or significant medical illness.
Descripción

Elig.phs001195.v1.p1.26

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3887511
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0018799
UMLS CUI [1,4]
C0020538
UMLS CUI [1,5]
C3843040
UMLS CUI [1,6]
C0221423
Have any history of hypersensitivity to atomoxetine, glaucoma, motor tics or with a family history or diagnosis of Tourette&#39;s syndrome.
Descripción

Elig.phs001195.v1.p1.27

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0076823
UMLS CUI [1,4]
C0017601
UMLS CUI [1,5]
C0751900
UMLS CUI [1,6]
C0241889
UMLS CUI [1,7]
C0011900
UMLS CUI [1,8]
C0040517
Have any preexisting severe gastrointestinal narrowing, small bowel inflammatory disease, intestinal adhesions, past history of peritonitis, or cystic fibrosis.
Descripción

Elig.phs001195.v1.p1.28

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521587
UMLS CUI [1,4]
C0021390
UMLS CUI [1,5]
C0267778
UMLS CUI [1,6]
C0262926
UMLS CUI [1,7]
C0031154
UMLS CUI [1,8]
C0010674
Be pregnant or nursing.
Descripción

Elig.phs001195.v1.p1.29

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Have a significant family history of early cardiovascular morbidity or mortality.
Descripción

Elig.phs001195.v1.p1.30

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C0007226
UMLS CUI [1,4]
C0026538
UMLS CUI [1,5]
C0026565
Have a diagnosis of adult asthma, including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonist or steroid therapy (due to potential serious adverse interactions with methamphetamine).
Descripción

Elig.phs001195.v1.p1.31

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C0004096
UMLS CUI [1,4]
C0262926
UMLS CUI [1,5]
C0582415
UMLS CUI [1,6]
C0040223
UMLS CUI [1,7]
C0521116
UMLS CUI [1,8]
C0332185
UMLS CUI [1,9]
C0574135
UMLS CUI [1,10]
C2065041
UMLS CUI [1,11]
C0205535
UMLS CUI [1,12]
C1527415
UMLS CUI [1,13]
C0001644
Be actively using albuterol or other beta agonist medications, regardless of formal diagnosis of asthma. (Inhalers are sometimes used by methamphetamine addicts to enhance methamphetamine delivery to the lungs.) If respiratory disease is excluded and the subject will consent to discontinue agonist use, s/he may be considered for inclusion.
Descripción

Elig.phs001195.v1.p1.32

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0001927
UMLS CUI [1,4]
C0001644
UMLS CUI [1,5]
C3641650
UMLS CUI [1,6]
C0011900
UMLS CUI [1,7]
C0004096
UMLS CUI [2,1]
C0332196
UMLS CUI [2,2]
C0035204
UMLS CUI [2,3]
C0600109
UMLS CUI [2,4]
C0457454
UMLS CUI [2,5]
C1524063
UMLS CUI [2,6]
C0001644
UMLS CUI [2,7]
C0518609
UMLS CUI [2,8]
C1512693
For subjects suspected to have asthma, but without formal diagnosis, 1) have a history of coughing and/or wheezing, 2) have a history of asthma and/or asthma treatment two or more years before, 3) have a history of other respiratory illness, e.g., complications of pulmonary disease (exclude if on beta agonists), 4) use over-the-counter agonist or allergy medication for respiratory problems (e.g., Primatene Mist): a detailed history and physical exam, pulmonary consult, and pulmonary function tests should be performed prior to including or excluding from the study or 5) have an FEV1 &lt;70 %.
Descripción

Elig.phs001195.v1.p1.33

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242114
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C0011900
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0010200
UMLS CUI [2,3]
C0043144
UMLS CUI [2,4]
C0004096
UMLS CUI [2,5]
C0013227
UMLS CUI [2,6]
C0205394
UMLS CUI [2,7]
C0035204
UMLS CUI [2,8]
C1524063
UMLS CUI [2,9]
C0013231
UMLS CUI [2,10]
C0001644
UMLS CUI [2,11]
C2054162
UMLS CUI [2,12]
C0429706
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0013231
UMLS CUI [3,3]
C0001644
UMLS CUI [3,4]
C2054162
UMLS CUI [3,5]
C1522508
UMLS CUI [3,6]
C0262926
UMLS CUI [3,7]
C0031809
UMLS CUI [3,8]
C0024119
UMLS CUI [3,9]
C0847577
Have any illness, condition, and/or use of medications that in the opinion of the site Principal Investigator and the admitting physician would preclude safe and/or successful completion of the study.
Descripción

Elig.phs001195.v1.p1.34

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0013227
UMLS CUI [1,5]
C0521102
UMLS CUI [1,6]
C2732579
Have active syphilis that has not been treated or refuse treatment for syphilis. Note: Syphilis testing will not be performed as part of this study and the study will rely solely on subjects&#39; self-report.
Descripción

Elig.phs001195.v1.p1.35

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0039128
UMLS CUI [1,3]
C0332155
UMLS CUI [1,4]
C1705116
UMLS CUI [1,5]
C0087111
UMLS CUI [1,6]
C2700446
Be undergoing HIV treatment with antiviral and non-antiviral therapy (participants who are HIV positive may not be eligible for cognitive assessments or brain scans and may only participate in the safety aspect of the protocol.)
Descripción

Elig.phs001195.v1.p1.36

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0280274
UMLS CUI [1,3]
C3846158
Have AIDS according to the current CDC criteria for AIDS - MMWR 1999;48 (#RR-13:29-31).
Descripción

Elig.phs001195.v1.p1.37

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0011900
UMLS CUI [1,4]
C0001175
Have neurological disorders including Parkinson&#39;s disease.
Descripción

Elig.phs001195.v1.p1.38

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0030567
Have evidence of significant liver or kidney dysfunction.
Descripción

Elig.phs001195.v1.p1.39

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0086565
UMLS CUI [1,4]
C3279454
Have a history of urinary retention or bladder outlet obstruction.
Descripción

Elig.phs001195.v1.p1.40

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0080274
UMLS CUI [1,3]
C0447585
UMLS CUI [1,4]
C0028778
Be UCLA students or staff.
Descripción

Elig.phs001195.v1.p1.41

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0041740
UMLS CUI [1,2]
C0565990
UMLS CUI [1,3]
C0038492
UMLS CUI [1,4]
C1552089
Have evidence of active tuberculosis infection.
Descripción

Elig.phs001195.v1.p1.42

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0151332
Only for MRI Procedures:
Descripción

Elig.phs001195.v1.p1.43

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0199171
We will exclude any participant from participating in MRI scans whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI. We will follow guidelines found in the manual, Magnetic Resonance: Bioeffects, Safety, and Patient Management 72, supplemented by the current information published on the International MR Safety Web Site: http://www.mrisafety.com/SafetyInfog.asp
Descripción

Elig.phs001195.v1.p1.44

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C1113679
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0376335
Control Subjects: <ol type="a">
Descripción

Elig.phs001195.v1.p1.45

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009932
Meet criteria for abuse or dependence of either alcohol or other illicit substances (other than nicotine).
Descripción

Elig.phs001195.v1.p1.46

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0038586
UMLS CUI [1,4]
C0038580
UMLS CUI [1,5]
C0085762
UMLS CUI [1,6]
C0281875
Have physiological dependence on alcohol or a sedative-hypnotic, (e.g., a benzodiazepine) that requires medical detoxification.
Descripción

Elig.phs001195.v1.p1.47

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278080
UMLS CUI [1,2]
C0005064
UMLS CUI [1,3]
C3854290
UMLS CUI [1,4]
C0001973
UMLS CUI [1,5]
C1514873
UMLS CUI [1,6]
C0150543
Meet the diagnostic criteria for the following Axis I disorders: psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
Descripción

Elig.phs001195.v1.p1.48

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0853193
UMLS CUI [1,4]
C0747055
UMLS CUI [1,5]
C0006111
UMLS CUI [1,6]
C0497327
UMLS CUI [1,7]
C1269683
UMLS CUI [1,8]
C0036341
UMLS CUI [1,9]
C0036337
Methamphetamine Subjects: <ol type="a">
Descripción

Elig.phs001195.v1.p1.49

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0025611
Meet DSM-IV criteria (by SCID) for drug dependence other than meth, with the exception of nicotine and/or marijuana abuse/dependence.
Descripción

Elig.phs001195.v1.p1.50

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C0220952
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C0038580
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C0028043
UMLS CUI [1,7]
C2363943
UMLS CUI [1,8]
C0024808
UMLS CUI [1,9]
C0013146
UMLS CUI [1,10]
C1510472
Any previous medically serious adverse reaction to methamphetamine including loss of consciousness, chest pain, or epileptic seizure resulting in hospitalization.
Descripción

Elig.phs001195.v1.p1.51

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0025611
UMLS CUI [1,4]
C0041657
UMLS CUI [1,5]
C0008031
UMLS CUI [1,6]
C4317109
UMLS CUI [1,7]
C0332294
UMLS CUI [1,8]
C0019993
Meeting diagnostic criteria or receiving psychopharmacological treatment for the following Axis I disorders within the last 6 months: anorexia nervosa, bulimia, psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
Descripción

Elig.phs001195.v1.p1.52

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C0679228
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C0679629
UMLS CUI [1,5]
C0270287
UMLS CUI [1,6]
C1517741
UMLS CUI [1,7]
C0205452
UMLS CUI [1,8]
C0439231
UMLS CUI [1,9]
C0003125
UMLS CUI [1,10]
C2267227
UMLS CUI [1,11]
C0033975
UMLS CUI [1,12]
C0853193
UMLS CUI [1,13]
C4062280
UMLS CUI [1,14]
C0497327
UMLS CUI [1,15]
C1269683
UMLS CUI [1,16]
C0036341
UMLS CUI [1,17]
C0036337
*Criteria for Discontinuation Following Initiation:* <ol type="1">
Descripción

Elig.phs001195.v1.p1.53

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Positive urine drug screen or breath test indicating illicit use of cocaine, methamphetamine, alcohol, opiates, or other abused drugs not delivered as part of this protocol;
Descripción

Elig.phs001195.v1.p1.54

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0006153
UMLS CUI [1,3]
C0281875
UMLS CUI [1,4]
C3496069
UMLS CUI [1,5]
C0025611
UMLS CUI [1,6]
C0001948
UMLS CUI [1,7]
C0376196
UMLS CUI [1,8]
C0205394
UMLS CUI [1,9]
C0687130
Inability to comply with study procedures;
Descripción

Elig.phs001195.v1.p1.55

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
Methamphetamine Subjects: Meet discontinuation criteria due to exaggerated response to methamphetamine, described below.
Descripción

Elig.phs001195.v1.p1.56

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025611
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C0457454
UMLS CUI [1,5]
C0243161
UMLS CUI [1,6]
C0442801
UMLS CUI [1,7]
C0041755
Participants must continue to meet inclusion criteria in order to remain in the protocol. Thus, MA administration procedures will not be initiated if there are clinically significant arrhythmias or if vital signs are outside of acceptable ranges:
Descripción

Elig.phs001195.v1.p1.57

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C1516637
UMLS CUI [1,5]
C0243161
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C3469597
UMLS CUI [2,3]
C0025611
UMLS CUI [2,4]
C2826293
UMLS CUI [2,5]
C0003811
UMLS CUI [2,6]
C0518766
UMLS CUI [2,7]
C1698059
UMLS CUI [2,8]
C1879533
UMLS CUI [2,9]
C1514721
Resting Pulse: 50-90 beats per minute.
Descripción

Elig.phs001195.v1.p1.58

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
Systolic Blood Pressure: 105-140mm Hg
Descripción

Elig.phs001195.v1.p1.59

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871470
Diastolic Blood Pressure: 45-90mm Hg
Descripción

Elig.phs001195.v1.p1.60

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428883
In addition, repeated doses of methamphetamine will not be administered (and the study physician or nurse practitioner will halt continued methamphetamine delivery) if there are behavioral manifestations of methamphetamine toxicity (agitation, psychosis, inability to cooperate with study procedures). Note that participants remain eligible to remain in the study provided that vital signs do not exceed the limits below.
Descripción

Elig.phs001195.v1.p1.61

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0025611
UMLS CUI [1,4]
C1272696
UMLS CUI [1,5]
C0542299
UMLS CUI [1,6]
C0678226
UMLS CUI [1,7]
C0600688
UMLS CUI [2,1]
C0025611
UMLS CUI [2,2]
C0600688
UMLS CUI [2,3]
C0085631
UMLS CUI [2,4]
C0033975
UMLS CUI [2,5]
C1299582
UMLS CUI [2,6]
C0525058
UMLS CUI [3,1]
C1527428
UMLS CUI [3,2]
C1302261
UMLS CUI [3,3]
C0518766
UMLS CUI [3,4]
C4047968
Systolic BP &gt;200mm Hg sustained; Diastolic BP &gt;110 mm Hg sustained; Heart rate &gt; (220 - age) x 0.85 bpm.
Descripción

Elig.phs001195.v1.p1.62

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0428883
UMLS CUI [1,3]
C0018810
A clinically significant ECG abnormality, such as: ST segment elevations in two or more continuous ads of greater than 0.1 mV; ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point; New bundle branch block; Mobitz II 20 or 30 heart block; Atrial fibrillation or atrial flutter or activation of any tachyarrhythmia for greater than 10 sec; QTc &gt;440 msec for males and &gt; 450 msec for females; An uncorrected QT of 470 msec or a rate-corrected QTc of 500 msec or greater is observed and does not revert to baseline within 10 min; Three or more consecutive ectopic ventricular complexes at a rate of greater than 100/min.
Descripción

Elig.phs001195.v1.p1.63

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0522055
UMLS CUI [2,1]
C2348120
UMLS CUI [2,2]
C0520886
UMLS CUI [3,1]
C2348120
UMLS CUI [3,2]
C0520887
UMLS CUI [4,1]
C0205314
UMLS CUI [4,2]
C0006384
UMLS CUI [5,1]
C0155700
UMLS CUI [6,1]
C0004238
UMLS CUI [6,2]
C0004239
UMLS CUI [6,3]
C1879547
UMLS CUI [6,4]
C0080203
UMLS CUI [6,5]
C0439093
UMLS CUI [6,6]
C0332168
UMLS CUI [7,1]
C1969409
UMLS CUI [8,1]
C4072785
UMLS CUI [8,2]
C0151878
UMLS CUI [8,3]
C1969409
UMLS CUI [8,4]
C0860814
UMLS CUI [8,5]
C1299585
UMLS CUI [8,6]
C0332156
UMLS CUI [8,7]
C1442488
UMLS CUI [8,8]
C0449238
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Similar models

Eligibility Criteria

6 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.1
Item
*Inclusion Criteria:* <ol type="1">
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.2
Item
Be fluently English-speaking volunteers.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0680274 (UMLS CUI [1,3])
Elig.phs001195.v1.p1.3
Item
Be between 18 and 50 years of age.
boolean
C0001779 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.4
Item
Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
boolean
C2364293 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C1576874 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C2364293 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Elig.phs001195.v1.p1.5
Item
If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized. <ol type="a">
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
C0232970 (UMLS CUI [1,5])
C0020699 (UMLS CUI [1,6])
C0015787 (UMLS CUI [1,7])
Elig.phs001195.v1.p1.6
Item
oral contraceptives
boolean
C0009905 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.7
Item
barrier (diaphragm or condom) with spermicide, or condom only
boolean
C0037862 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0679782 (UMLS CUI [1,3])
Elig.phs001195.v1.p1.8
Item
intrauterine progesterone, or non-hormonal contraceptive system
boolean
C0021900 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.9
Item
levonorgestrel implant
boolean
C1253292 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.10
Item
medroxyprogesterone acetate contraceptive injection
boolean
C2092240 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.11
Item
complete abstinence from sexual intercourse
boolean
C0036899 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.12
Item
Control Subjects: <ol type="a">
boolean
C0009932 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.13
Item
Must have vital signs as follows during two visits prior to medication administration: resting pulse between 50 and 90 bpm, blood pressures between 105-150mm Hg systolic and 45-90mm Hg diastolic.
boolean
C0518766 (UMLS CUI [1,1])
C0205448 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,6])
C1704788 (UMLS CUI [2,1])
C0232117 (UMLS CUI [2,2])
C0005823 (UMLS CUI [2,3])
Elig.phs001195.v1.p1.14
Item
Have an ECG performed that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
boolean
C0438154 (UMLS CUI [1,1])
C0232202 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0232217 (UMLS CUI [1,4])
C1298908 (UMLS CUI [1,5])
C2985739 (UMLS CUI [1,6])
C0003811 (UMLS CUI [1,7])
Elig.phs001195.v1.p1.15
Item
Agree to abstain from any and all substances of abuse during the study, evidenced by toxicology-negative urine each day prior to study procedures.
boolean
C0680240 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0852616 (UMLS CUI [1,6])
C1513916 (UMLS CUI [1,7])
C1278212 (UMLS CUI [1,8])
C0332152 (UMLS CUI [1,9])
C2347804 (UMLS CUI [1,10])
Elig.phs001195.v1.p1.16
Item
Methamphetamine Subjects: <ol type="a">
boolean
C0025611 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.17
Item
Must meet DSM-IV criteria for methamphetamine abuse or dependence.
boolean
C0220952 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0025611 (UMLS CUI [1,4])
C0038586 (UMLS CUI [1,5])
C0038580 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.18
Item
Have smoked or injected methamphetamine for more than two years.
boolean
C1608325 (UMLS CUI [1,1])
C0683092 (UMLS CUI [1,2])
C0025611 (UMLS CUI [1,3])
C3844700 (UMLS CUI [1,4])
C0439234 (UMLS CUI [1,5])
Elig.phs001195.v1.p1.19
Item
Produce a methamphetamine-positive urine prior to study entry.
boolean
C0743300 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0025611 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.20
Item
Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 105-150mm Hg systolic and 45-90mm Hg diastolic. Note: Methamphetamine Abusing participants may present with elevated vital signs during the intake screening phase as a result of methamphetamine intoxication or anxiety and elevated vital signs may occur after inclusion to the study prior to administration or Methamphetamine or study compound. Participants must have vital signs within the aforementioned range on two timepoints (i.e., morning or night vital collection) during two consecutive days prior to randomization or participation was terminated.
boolean
C0518766 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
C1821417 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
C1997894 (UMLS CUI [2,1])
C0025611 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2,3])
C0518766 (UMLS CUI [2,4])
C3163633 (UMLS CUI [2,5])
C0347984 (UMLS CUI [2,6])
C1710477 (UMLS CUI [2,7])
C0205390 (UMLS CUI [2,8])
C1274040 (UMLS CUI [2,9])
C0025611 (UMLS CUI [2,10])
C0728899 (UMLS CUI [2,11])
C0003467 (UMLS CUI [2,12])
C1997894 (UMLS CUI [3,1])
C0025611 (UMLS CUI [3,2])
C0038586 (UMLS CUI [3,3])
C0518766 (UMLS CUI [3,4])
C3163633 (UMLS CUI [3,5])
C0231290 (UMLS CUI [3,6])
C1512693 (UMLS CUI [3,7])
C0332152 (UMLS CUI [3,8])
C1533734 (UMLS CUI [3,9])
C0025611 (UMLS CUI [3,10])
C0304229 (UMLS CUI [3,11])
C0518766 (UMLS CUI [4,1])
C0332285 (UMLS CUI [4,2])
C1514721 (UMLS CUI [4,3])
C1524031 (UMLS CUI [4,4])
C0205448 (UMLS CUI [4,5])
C2348792 (UMLS CUI [4,6])
C0332152 (UMLS CUI [4,7])
C0034656 (UMLS CUI [4,8])
Elig.phs001195.v1.p1.21
Item
Have an ECG performed that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
boolean
C0438154 (UMLS CUI [1,1])
C0232202 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0232217 (UMLS CUI [1,4])
C1298908 (UMLS CUI [1,5])
C2985739 (UMLS CUI [1,6])
C0003811 (UMLS CUI [1,7])
Elig.phs001195.v1.p1.22
Item
Agree to abstain from MA during the study, evidenced by a MA-negative urine each morning of the study.
boolean
C0680240 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0025611 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C1513916 (UMLS CUI [1,6])
C1278212 (UMLS CUI [1,7])
C0332173 (UMLS CUI [1,8])
C0332170 (UMLS CUI [1,9])
Elig.phs001195.v1.p1.23
Item
*Exclusion Criteria:* <ol type="1">
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.24
Item
A current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
boolean
C1444635 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,3])
C0014544 (UMLS CUI [1,4])
C0205263 (UMLS CUI [1,5])
C0036572 (UMLS CUI [1,6])
C0009952 (UMLS CUI [1,7])
C2317090 (UMLS CUI [1,8])
Elig.phs001195.v1.p1.25
Item
A history of head trauma that resulted in neurological sequelae (e.g., with loss of consciousness [LOC] &gt;15 minutes, or that required hospitalization. Also, individuals with 3 or more head injuries with LOC &gt;5 minutes will be excluded).
boolean
C0262926 (UMLS CUI [1,1])
C0018674 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,4])
C0243088 (UMLS CUI [1,5])
C0449238 (UMLS CUI [1,6])
C0041657 (UMLS CUI [1,7])
C0019993 (UMLS CUI [1,8])
Elig.phs001195.v1.p1.26
Item
Evidence of clinically significant heart disease, hypertension or significant medical illness.
boolean
C3887511 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
C0020538 (UMLS CUI [1,4])
C3843040 (UMLS CUI [1,5])
C0221423 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.27
Item
Have any history of hypersensitivity to atomoxetine, glaucoma, motor tics or with a family history or diagnosis of Tourette&#39;s syndrome.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0076823 (UMLS CUI [1,3])
C0017601 (UMLS CUI [1,4])
C0751900 (UMLS CUI [1,5])
C0241889 (UMLS CUI [1,6])
C0011900 (UMLS CUI [1,7])
C0040517 (UMLS CUI [1,8])
Elig.phs001195.v1.p1.28
Item
Have any preexisting severe gastrointestinal narrowing, small bowel inflammatory disease, intestinal adhesions, past history of peritonitis, or cystic fibrosis.
boolean
C2347662 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521587 (UMLS CUI [1,3])
C0021390 (UMLS CUI [1,4])
C0267778 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,6])
C0031154 (UMLS CUI [1,7])
C0010674 (UMLS CUI [1,8])
Elig.phs001195.v1.p1.29
Item
Be pregnant or nursing.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.30
Item
Have a significant family history of early cardiovascular morbidity or mortality.
boolean
C0241889 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0007226 (UMLS CUI [1,3])
C0026538 (UMLS CUI [1,4])
C0026565 (UMLS CUI [1,5])
Elig.phs001195.v1.p1.31
Item
Have a diagnosis of adult asthma, including those with a history of acute asthma within the past two years, and those with current or recent (past 2 years) treatment with inhaled or oral beta-agonist or steroid therapy (due to potential serious adverse interactions with methamphetamine).
boolean
C0011900 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C0582415 (UMLS CUI [1,5])
C0040223 (UMLS CUI [1,6])
C0521116 (UMLS CUI [1,7])
C0332185 (UMLS CUI [1,8])
C0574135 (UMLS CUI [1,9])
C2065041 (UMLS CUI [1,10])
C0205535 (UMLS CUI [1,11])
C1527415 (UMLS CUI [1,12])
C0001644 (UMLS CUI [1,13])
Elig.phs001195.v1.p1.32
Item
Be actively using albuterol or other beta agonist medications, regardless of formal diagnosis of asthma. (Inhalers are sometimes used by methamphetamine addicts to enhance methamphetamine delivery to the lungs.) If respiratory disease is excluded and the subject will consent to discontinue agonist use, s/he may be considered for inclusion.
boolean
C0205177 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0001927 (UMLS CUI [1,3])
C0001644 (UMLS CUI [1,4])
C3641650 (UMLS CUI [1,5])
C0011900 (UMLS CUI [1,6])
C0004096 (UMLS CUI [1,7])
C0332196 (UMLS CUI [2,1])
C0035204 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0457454 (UMLS CUI [2,4])
C1524063 (UMLS CUI [2,5])
C0001644 (UMLS CUI [2,6])
C0518609 (UMLS CUI [2,7])
C1512693 (UMLS CUI [2,8])
Elig.phs001195.v1.p1.33
Item
For subjects suspected to have asthma, but without formal diagnosis, 1) have a history of coughing and/or wheezing, 2) have a history of asthma and/or asthma treatment two or more years before, 3) have a history of other respiratory illness, e.g., complications of pulmonary disease (exclude if on beta agonists), 4) use over-the-counter agonist or allergy medication for respiratory problems (e.g., Primatene Mist): a detailed history and physical exam, pulmonary consult, and pulmonary function tests should be performed prior to including or excluding from the study or 5) have an FEV1 &lt;70 %.
boolean
C0242114 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
C0262926 (UMLS CUI [2,1])
C0010200 (UMLS CUI [2,2])
C0043144 (UMLS CUI [2,3])
C0004096 (UMLS CUI [2,4])
C0013227 (UMLS CUI [2,5])
C0205394 (UMLS CUI [2,6])
C0035204 (UMLS CUI [2,7])
C1524063 (UMLS CUI [2,8])
C0013231 (UMLS CUI [2,9])
C0001644 (UMLS CUI [2,10])
C2054162 (UMLS CUI [2,11])
C0429706 (UMLS CUI [2,12])
C1524063 (UMLS CUI [3,1])
C0013231 (UMLS CUI [3,2])
C0001644 (UMLS CUI [3,3])
C2054162 (UMLS CUI [3,4])
C1522508 (UMLS CUI [3,5])
C0262926 (UMLS CUI [3,6])
C0031809 (UMLS CUI [3,7])
C0024119 (UMLS CUI [3,8])
C0847577 (UMLS CUI [3,9])
Elig.phs001195.v1.p1.34
Item
Have any illness, condition, and/or use of medications that in the opinion of the site Principal Investigator and the admitting physician would preclude safe and/or successful completion of the study.
boolean
C0012634 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0521102 (UMLS CUI [1,5])
C2732579 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.35
Item
Have active syphilis that has not been treated or refuse treatment for syphilis. Note: Syphilis testing will not be performed as part of this study and the study will rely solely on subjects&#39; self-report.
boolean
C0205177 (UMLS CUI [1,1])
C0039128 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1705116 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
C2700446 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.36
Item
Be undergoing HIV treatment with antiviral and non-antiviral therapy (participants who are HIV positive may not be eligible for cognitive assessments or brain scans and may only participate in the safety aspect of the protocol.)
boolean
C0019682 (UMLS CUI [1,1])
C0280274 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Elig.phs001195.v1.p1.37
Item
Have AIDS according to the current CDC criteria for AIDS - MMWR 1999;48 (#RR-13:29-31).
boolean
C1550543 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0001175 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.38
Item
Have neurological disorders including Parkinson&#39;s disease.
boolean
C0027765 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.39
Item
Have evidence of significant liver or kidney dysfunction.
boolean
C0332120 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0086565 (UMLS CUI [1,3])
C3279454 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.40
Item
Have a history of urinary retention or bladder outlet obstruction.
boolean
C0262926 (UMLS CUI [1,1])
C0080274 (UMLS CUI [1,2])
C0447585 (UMLS CUI [1,3])
C0028778 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.41
Item
Be UCLA students or staff.
boolean
C0041740 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
C0038492 (UMLS CUI [1,3])
C1552089 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.42
Item
Have evidence of active tuberculosis infection.
boolean
C0332120 (UMLS CUI [1,1])
C0151332 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.43
Item
Only for MRI Procedures:
boolean
C0024485 (UMLS CUI [1,1])
C0199171 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.44
Item
We will exclude any participant from participating in MRI scans whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI. We will follow guidelines found in the manual, Magnetic Resonance: Bioeffects, Safety, and Patient Management 72, supplemented by the current information published on the International MR Safety Web Site: http://www.mrisafety.com/SafetyInfog.asp
boolean
C3693688 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0376335 (UMLS CUI [1,4])
Elig.phs001195.v1.p1.45
Item
Control Subjects: <ol type="a">
boolean
C0009932 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.46
Item
Meet criteria for abuse or dependence of either alcohol or other illicit substances (other than nicotine).
boolean
C1550543 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,3])
C0038580 (UMLS CUI [1,4])
C0085762 (UMLS CUI [1,5])
C0281875 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.47
Item
Have physiological dependence on alcohol or a sedative-hypnotic, (e.g., a benzodiazepine) that requires medical detoxification.
boolean
C0278080 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C3854290 (UMLS CUI [1,3])
C0001973 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C0150543 (UMLS CUI [1,6])
Elig.phs001195.v1.p1.48
Item
Meet the diagnostic criteria for the following Axis I disorders: psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
boolean
C0270287 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0853193 (UMLS CUI [1,3])
C0747055 (UMLS CUI [1,4])
C0006111 (UMLS CUI [1,5])
C0497327 (UMLS CUI [1,6])
C1269683 (UMLS CUI [1,7])
C0036341 (UMLS CUI [1,8])
C0036337 (UMLS CUI [1,9])
Elig.phs001195.v1.p1.49
Item
Methamphetamine Subjects: <ol type="a">
boolean
C0681850 (UMLS CUI [1,1])
C0025611 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.50
Item
Meet DSM-IV criteria (by SCID) for drug dependence other than meth, with the exception of nicotine and/or marijuana abuse/dependence.
boolean
C1550543 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0038580 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C0028043 (UMLS CUI [1,6])
C2363943 (UMLS CUI [1,7])
C0024808 (UMLS CUI [1,8])
C0013146 (UMLS CUI [1,9])
C1510472 (UMLS CUI [1,10])
Elig.phs001195.v1.p1.51
Item
Any previous medically serious adverse reaction to methamphetamine including loss of consciousness, chest pain, or epileptic seizure resulting in hospitalization.
boolean
C0205156 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0025611 (UMLS CUI [1,3])
C0041657 (UMLS CUI [1,4])
C0008031 (UMLS CUI [1,5])
C4317109 (UMLS CUI [1,6])
C0332294 (UMLS CUI [1,7])
C0019993 (UMLS CUI [1,8])
Elig.phs001195.v1.p1.52
Item
Meeting diagnostic criteria or receiving psychopharmacological treatment for the following Axis I disorders within the last 6 months: anorexia nervosa, bulimia, psychosis, bipolar I disorder, organic brain disease, dementia, major depression, schizoaffective disorder, or schizophrenia.
boolean
C1550543 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0679629 (UMLS CUI [1,4])
C0270287 (UMLS CUI [1,5])
C1517741 (UMLS CUI [1,6])
C0205452 (UMLS CUI [1,7])
C0439231 (UMLS CUI [1,8])
C0003125 (UMLS CUI [1,9])
C2267227 (UMLS CUI [1,10])
C0033975 (UMLS CUI [1,11])
C0853193 (UMLS CUI [1,12])
C4062280 (UMLS CUI [1,13])
C0497327 (UMLS CUI [1,14])
C1269683 (UMLS CUI [1,15])
C0036341 (UMLS CUI [1,16])
C0036337 (UMLS CUI [1,17])
Elig.phs001195.v1.p1.53
Item
*Criteria for Discontinuation Following Initiation:* <ol type="1">
boolean
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Elig.phs001195.v1.p1.54
Item
Positive urine drug screen or breath test indicating illicit use of cocaine, methamphetamine, alcohol, opiates, or other abused drugs not delivered as part of this protocol;
boolean
C0743300 (UMLS CUI [1,1])
C0006153 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
C3496069 (UMLS CUI [1,4])
C0025611 (UMLS CUI [1,5])
C0001948 (UMLS CUI [1,6])
C0376196 (UMLS CUI [1,7])
C0205394 (UMLS CUI [1,8])
C0687130 (UMLS CUI [1,9])
Elig.phs001195.v1.p1.55
Item
Inability to comply with study procedures;
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.56
Item
Methamphetamine Subjects: Meet discontinuation criteria due to exaggerated response to methamphetamine, described below.
boolean
C0025611 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C0442801 (UMLS CUI [1,6])
C0041755 (UMLS CUI [1,7])
Elig.phs001195.v1.p1.57
Item
Participants must continue to meet inclusion criteria in order to remain in the protocol. Thus, MA administration procedures will not be initiated if there are clinically significant arrhythmias or if vital signs are outside of acceptable ranges:
boolean
C0681850 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C1298908 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
C0025611 (UMLS CUI [2,3])
C2826293 (UMLS CUI [2,4])
C0003811 (UMLS CUI [2,5])
C0518766 (UMLS CUI [2,6])
C1698059 (UMLS CUI [2,7])
C1879533 (UMLS CUI [2,8])
C1514721 (UMLS CUI [2,9])
Elig.phs001195.v1.p1.58
Item
Resting Pulse: 50-90 beats per minute.
boolean
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Elig.phs001195.v1.p1.59
Item
Systolic Blood Pressure: 105-140mm Hg
boolean
C0871470 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.60
Item
Diastolic Blood Pressure: 45-90mm Hg
boolean
C0428883 (UMLS CUI [1,1])
Elig.phs001195.v1.p1.61
Item
In addition, repeated doses of methamphetamine will not be administered (and the study physician or nurse practitioner will halt continued methamphetamine delivery) if there are behavioral manifestations of methamphetamine toxicity (agitation, psychosis, inability to cooperate with study procedures). Note that participants remain eligible to remain in the study provided that vital signs do not exceed the limits below.
boolean
C0205341 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0025611 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0542299 (UMLS CUI [1,5])
C0678226 (UMLS CUI [1,6])
C0600688 (UMLS CUI [1,7])
C0025611 (UMLS CUI [2,1])
C0600688 (UMLS CUI [2,2])
C0085631 (UMLS CUI [2,3])
C0033975 (UMLS CUI [2,4])
C1299582 (UMLS CUI [2,5])
C0525058 (UMLS CUI [2,6])
C1527428 (UMLS CUI [3,1])
C1302261 (UMLS CUI [3,2])
C0518766 (UMLS CUI [3,3])
C4047968 (UMLS CUI [3,4])
Elig.phs001195.v1.p1.62
Item
Systolic BP &gt;200mm Hg sustained; Diastolic BP &gt;110 mm Hg sustained; Heart rate &gt; (220 - age) x 0.85 bpm.
boolean
C0871470 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
Elig.phs001195.v1.p1.63
Item
A clinically significant ECG abnormality, such as: ST segment elevations in two or more continuous ads of greater than 0.1 mV; ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point; New bundle branch block; Mobitz II 20 or 30 heart block; Atrial fibrillation or atrial flutter or activation of any tachyarrhythmia for greater than 10 sec; QTc &gt;440 msec for males and &gt; 450 msec for females; An uncorrected QT of 470 msec or a rate-corrected QTc of 500 msec or greater is observed and does not revert to baseline within 10 min; Three or more consecutive ectopic ventricular complexes at a rate of greater than 100/min.
boolean
C2985739 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2348120 (UMLS CUI [2,1])
C0520886 (UMLS CUI [2,2])
C2348120 (UMLS CUI [3,1])
C0520887 (UMLS CUI [3,2])
C0205314 (UMLS CUI [4,1])
C0006384 (UMLS CUI [4,2])
C0155700 (UMLS CUI [5,1])
C0004238 (UMLS CUI [6,1])
C0004239 (UMLS CUI [6,2])
C1879547 (UMLS CUI [6,3])
C0080203 (UMLS CUI [6,4])
C0439093 (UMLS CUI [6,5])
C0332168 (UMLS CUI [6,6])
C1969409 (UMLS CUI [7,1])
C4072785 (UMLS CUI [8,1])
C0151878 (UMLS CUI [8,2])
C1969409 (UMLS CUI [8,3])
C0860814 (UMLS CUI [8,4])
C1299585 (UMLS CUI [8,5])
C0332156 (UMLS CUI [8,6])
C1442488 (UMLS CUI [8,7])
C0449238 (UMLS CUI [8,8])
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