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] >15 minutes, or that required hospitalization. Also, individuals with 3 or more head injuries with LOC >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'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 <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' 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'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 >200mm Hg sustained; Diastolic BP >110 mm Hg sustained; Heart rate > (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 >440 msec for males and > 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])