{"protocolSection":{"identificationModule":{"nctId":"NCT04178993","orgStudyIdInfo":{"id":"BED(IN):40"},"secondaryIdInfos":[{"id":"R01DA047391","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA047391"}],"organization":{"fullName":"University of Kentucky","class":"OTHER"},"briefTitle":"Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]","officialTitle":"A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder"},"statusModule":{"statusVerifiedDate":"2022-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-09-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-05-05","type":"ACTUAL"},"completionDateStruct":{"date":"2021-05-05","type":"ACTUAL"},"studyFirstSubmitDate":"2019-08-09","studyFirstSubmitQcDate":"2019-11-25","studyFirstPostDateStruct":{"date":"2019-11-26","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-09-23","resultsFirstSubmitQcDate":"2022-12-12","resultsFirstPostDateStruct":{"date":"2023-01-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-12-12","lastUpdatePostDateStruct":{"date":"2023-01-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Craig Rush","investigatorTitle":"Professor","investigatorAffiliation":"University of Kentucky"},"leadSponsor":{"name":"Craig Rush","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods."},"conditionsModule":{"conditions":["Methamphetamine Use Disorder"],"keywords":["Methamphetamine","Methylphenidate","Duloxetine Hydrochloride","Central Nervous System Stimulants","Physiological Effects of Drugs","Dopamine Uptake Inhibitors","Serotonin and Noradrenaline Reuptake Inhibitors","Membrane Transport Modulators","Neurotransmitter Agents","Dopamine Agents","Molecular Mechanisms of Pharmacological Action","Sensory System Agents","Peripheral Nervous System Agents","Vasoconstrictor Agents","Antidepressive Agents","Psychotropic Drugs"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":8,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo Comparator: Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.","interventionNames":["Drug: Methamphetamine","Drug: Methylphenidate","Drug: Placebo oral capsule"]},{"label":"Active Comparator: Duloxetine","type":"ACTIVE_COMPARATOR","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.","interventionNames":["Drug: Methamphetamine","Drug: Methylphenidate","Drug: Placebo oral capsule","Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Methamphetamine","description":"In each arm, subjects will receive doses of methamphetamine.","armGroupLabels":["Active Comparator: Duloxetine","Placebo Comparator: Placebo"],"otherNames":["Metamfetamine"]},{"type":"DRUG","name":"Methylphenidate","description":"In each arm, subjects will receive methylphenidate capsules.","armGroupLabels":["Active Comparator: Duloxetine","Placebo Comparator: Placebo"],"otherNames":["Metadate®"]},{"type":"DRUG","name":"Placebo oral capsule","description":"In each arm, subjects will receive placebo capsules.","armGroupLabels":["Active Comparator: Duloxetine","Placebo Comparator: Placebo"],"otherNames":["Lactose"]},{"type":"DRUG","name":"Duloxetine","description":"Subjects will receive duloxetine capsules in the duloxetine arm.","armGroupLabels":["Active Comparator: Duloxetine"],"otherNames":["Cymbalta®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","timeFrame":"Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week"},{"measure":"Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week"},{"measure":"Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week"},{"measure":"Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week"}],"secondaryOutcomes":[{"measure":"Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."},{"measure":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","timeFrame":"Daily over approximately 1 week of inpatient stay."}],"otherOutcomes":[{"measure":"Attentional Bias","description":"Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to \"no-go\" targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond.","timeFrame":"12 sessions over approximately 4.5 weeks"},{"measure":"Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)","description":"A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia.","timeFrame":"4 times over approximately 4.5 weeks"},{"measure":"Delay Discounting for Methamphetamine","description":"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered \"now\" or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \\[e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later\\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).","timeFrame":"4 sessions over approximately 4.5 weeks"},{"measure":"Delay Discounting for Money","description":"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered \"now\" or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \\[e.g., smaller sum of money given now as opposed to a larger sum given later\\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).","timeFrame":"4 sessions over approximately 4.5 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* recent use of inhaled (i.e., snorted), smoked or injected methamphetamine\n\nExclusion Criteria:\n\n* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.\n* Current or past histories of substance use that are deemed by the study physicians to interfere with study completion.\n* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation.\n* Females not currently using effective birth control.\n* Contraindications to methamphetamine, methylphenidate, or duloxetine.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"University of Kentucky","city":"Lexington","state":"Kentucky","zip":"40507","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}},{"facility":"University of Kentucky Medical Center","city":"Lexington","state":"Kentucky","zip":"40536","country":"United States","geoPoint":{"lat":37.98869,"lon":-84.47772}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"FG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"BG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38","spread":"13.08"},{"groupId":"BG001","value":"41.5","spread":"13.11"},{"groupId":"BG002","value":"39.75","spread":"11.07"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Trials Completed","timeFrame":"Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0","spread":"0"}]}]},{"title":"Methamphetamine (10mg)","categories":[{"measurements":[{"groupId":"OG000","value":"3.33","spread":"5.77"},{"groupId":"OG001","value":"7.25","spread":"4.86"}]}]},{"title":"Methamphetamine (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"0"},{"groupId":"OG001","value":"9.75","spread":"0.50"}]}]}]},{"type":"PRIMARY","title":"Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Trials Completed","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"2.50","spread":"5.00"}]}]},{"title":"Methamphetamine (10mg)","categories":[{"measurements":[{"groupId":"OG000","value":"6.67","spread":"5.77"},{"groupId":"OG001","value":"7.00","spread":"4.69"}]}]},{"title":"Methamphetamine (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"8.00","spread":"3.46"},{"groupId":"OG001","value":"9.75","spread":"0.50"}]}]}]},{"type":"PRIMARY","title":"Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Trials Completed","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"1.67","spread":"2.89"},{"groupId":"OG001","value":"0","spread":"0"}]}]},{"title":"Methamphetamine (10mg)","categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"0"},{"groupId":"OG001","value":"5.00","spread":"5.77"}]}]},{"title":"Methamphetamine (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"0"},{"groupId":"OG001","value":"10","spread":"0"}]}]}]},{"type":"PRIMARY","title":"Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.","description":"Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to \"work\" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Trials Completed","timeFrame":"Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"2.33","spread":"4.04"},{"groupId":"OG001","value":"0","spread":"0"}]}]},{"title":"Methamphetamine (10mg)","categories":[{"measurements":[{"groupId":"OG000","value":"3.33","spread":"5.77"},{"groupId":"OG001","value":"7.50","spread":"5.00"}]}]},{"title":"Methamphetamine (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"0"},{"groupId":"OG001","value":"9.75","spread":"0.50"}]}]}]},{"type":"SECONDARY","title":"Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats Per Minute","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"77.67","spread":"16.17"},{"groupId":"OG001","value":"78.00","spread":"6.98"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"87.33","spread":"15.14"},{"groupId":"OG001","value":"77.25","spread":"15.37"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"81.33","spread":"12.01"},{"groupId":"OG001","value":"83.75","spread":"15.20"}]}]}]},{"type":"SECONDARY","title":"Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats Per Minute","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"83.67","spread":"2.06"},{"groupId":"OG001","value":"76.00","spread":"8.41"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"84.33","spread":"8.50"},{"groupId":"OG001","value":"78.50","spread":"15.63"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"85.67","spread":"8.74"},{"groupId":"OG001","value":"89.50","spread":"16.90"}]}]}]},{"type":"SECONDARY","title":"Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats Per Minute","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"85.00","spread":"13.08"},{"groupId":"OG001","value":"91.25","spread":"23.47"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"89.67","spread":"10.21"},{"groupId":"OG001","value":"87.75","spread":"17.50"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"87.67","spread":"12.86"},{"groupId":"OG001","value":"87.00","spread":"15.08"}]}]}]},{"type":"SECONDARY","title":"Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats Per Minute","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"87.33","spread":"15.28"},{"groupId":"OG001","value":"88.00","spread":"19.11"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"83.67","spread":"11.72"},{"groupId":"OG001","value":"87.50","spread":"10.50"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"99.67","spread":"10.69"},{"groupId":"OG001","value":"88.00","spread":"19.36"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"132.67","spread":"2.89"},{"groupId":"OG001","value":"128.75","spread":"16.58"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"133.00","spread":"13.45"},{"groupId":"OG001","value":"131.00","spread":"11.83"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"132.67","spread":"5.03"},{"groupId":"OG001","value":"144.25","spread":"14.08"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"129.67","spread":"2.31"},{"groupId":"OG001","value":"124.25","spread":"25.02"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"131.67","spread":"18.61"},{"groupId":"OG001","value":"128.00","spread":"17.22"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"130.33","spread":"13.20"},{"groupId":"OG001","value":"132.75","spread":"15.95"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"133.33","spread":"2.08"},{"groupId":"OG001","value":"129.75","spread":"11.47"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"129.00","spread":"12.77"},{"groupId":"OG001","value":"132.25","spread":"15.41"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"130.00","spread":"10.44"},{"groupId":"OG001","value":"139.25","spread":"11.67"}]}]}]},{"type":"SECONDARY","title":"Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"139.00","spread":"4.00"},{"groupId":"OG001","value":"127.00","spread":"15.06"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"138.67","spread":"11.59"},{"groupId":"OG001","value":"129.75","spread":"14.97"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"139.67","spread":"3.06"},{"groupId":"OG001","value":"135.25","spread":"15.39"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"80.00","spread":"3.00"},{"groupId":"OG001","value":"78.50","spread":"7.77"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"82.33","spread":"0.58"},{"groupId":"OG001","value":"83.75","spread":"9.54"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"87.33","spread":"5.51"},{"groupId":"OG001","value":"86.25","spread":"7.89"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"81.67","spread":"4.51"},{"groupId":"OG001","value":"74.50","spread":"10.02"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"85.33","spread":"8.50"},{"groupId":"OG001","value":"83.25","spread":"11.03"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"83.00","spread":"3.61"},{"groupId":"OG001","value":"85.00","spread":"7.96"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"78.00","spread":"2.65"},{"groupId":"OG001","value":"81.00","spread":"9.56"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"84.67","spread":"5.51"},{"groupId":"OG001","value":"82.25","spread":"8.10"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"84.67","spread":"6.51"},{"groupId":"OG001","value":"85.00","spread":"6.06"}]}]}]},{"type":"SECONDARY","title":"Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of Mercury","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"82.67","spread":"5.51"},{"groupId":"OG001","value":"82.25","spread":"5.74"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"81.67","spread":"8.08"},{"groupId":"OG001","value":"82.25","spread":"7.93"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"88.33","spread":"4.73"},{"groupId":"OG001","value":"84.25","spread":"10.37"}]}]}]},{"type":"SECONDARY","title":"Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degrees Fahrenheit","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.10","spread":"0.26"},{"groupId":"OG001","value":"98.45","spread":"0.10"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.23","spread":"0.40"},{"groupId":"OG001","value":"98.48","spread":"0.21"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.40","spread":"0.36"},{"groupId":"OG001","value":"98.48","spread":"0.19"}]}]}]},{"type":"SECONDARY","title":"Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degrees Fahrenheit","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.37","spread":"0.23"},{"groupId":"OG001","value":"98.50","spread":"0.08"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.10","spread":"0.36"},{"groupId":"OG001","value":"98.75","spread":"0.26"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.27","spread":"0.32"},{"groupId":"OG001","value":"98.35","spread":"0.10"}]}]}]},{"type":"SECONDARY","title":"Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degrees Fahrenheit","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.17","spread":"0.15"},{"groupId":"OG001","value":"98.60","spread":"0.22"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.13","spread":"0.40"},{"groupId":"OG001","value":"98.65","spread":"0.17"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.43","spread":"0.15"},{"groupId":"OG001","value":"98.55","spread":"0.26"}]}]}]},{"type":"SECONDARY","title":"Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.","description":"Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degrees Fahrenheit","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methamphetamine (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.37","spread":"0.35"},{"groupId":"OG001","value":"98.65","spread":"0.17"}]}]},{"title":"Methamphetamine (10 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.43","spread":"0.15"},{"groupId":"OG001","value":"98.65","spread":"0.06"}]}]},{"title":"Methamphetamine (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"98.47","spread":"0.35"},{"groupId":"OG001","value":"98.58","spread":"0.10"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"1.53"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"1.15"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"1.50","spread":"3.00"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.25","spread":"0.50"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"1.67","spread":"2.89"},{"groupId":"OG001","value":"1.50","spread":"3.00"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"2.25","spread":"4.50"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.25","spread":"0.50"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"1.15"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.25","spread":"0.50"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"1.25","spread":"2.50"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"22.33","spread":"35.28"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"1.00","spread":"2.00"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"1.15"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"3.00","spread":"5.20"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"4.33","spread":"6.66"},{"groupId":"OG001","value":"12.50","spread":"23.04"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.58"},{"groupId":"OG001","value":"2.25","spread":"4.50"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"15.67","spread":"14.29"},{"groupId":"OG001","value":"18.25","spread":"36.50"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.73"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"15.33","spread":"24.83"},{"groupId":"OG001","value":"25.50","spread":"34.84"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"23.00","spread":"38.97"},{"groupId":"OG001","value":"22.25","spread":"35.98"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"46.33","spread":"45.06"},{"groupId":"OG001","value":"23.50","spread":"32.25"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"7.00","spread":"9.54"},{"groupId":"OG001","value":"11.50","spread":"21.05"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"11.33","spread":"19.63"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"21.33","spread":"36.09"},{"groupId":"OG001","value":"14.25","spread":"18.15"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"33.67","spread":"57.45"},{"groupId":"OG001","value":"15.00","spread":"15.10"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"10.67","spread":"18.48"},{"groupId":"OG001","value":"8.25","spread":"11.32"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"9.33","spread":"16.17"},{"groupId":"OG001","value":"12.00","spread":"14.28"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"12.67","spread":"20.21"},{"groupId":"OG001","value":"13.75","spread":"15.95"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"2.67","spread":"4.62"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"12.67","spread":"20.21"},{"groupId":"OG001","value":"16.00","spread":"19.13"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. 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Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"1.33","spread":"2.31"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.58"},{"groupId":"OG001","value":"1.25","spread":"2.50"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"25.33","spread":"39.55"},{"groupId":"OG001","value":"15.50","spread":"27.01"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"2.33","spread":"4.04"},{"groupId":"OG001","value":"0.75","spread":"1.50"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"33.00","spread":"54.58"},{"groupId":"OG001","value":"14.75","spread":"29.50"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"7.00","spread":"12.12"},{"groupId":"OG001","value":"1.25","spread":"2.50"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"28.00","spread":"41.68"},{"groupId":"OG001","value":"24.75","spread":"27.22"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"38.00","spread":"54.15"},{"groupId":"OG001","value":"21.25","spread":"27.71"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"41.67","spread":"51.81"},{"groupId":"OG001","value":"23.75","spread":"26.74"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"12.33","spread":"20.50"},{"groupId":"OG001","value":"15.00","spread":"26.77"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"5.33","spread":"9.24"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"31.67","spread":"48.85"},{"groupId":"OG001","value":"23.25","spread":"26.89"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"34.33","spread":"49.33"},{"groupId":"OG001","value":"24.75","spread":"26.29"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"29.00","spread":"49.37"},{"groupId":"OG001","value":"6.75","spread":"11.59"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"28.00","spread":"47.63"},{"groupId":"OG001","value":"20.50","spread":"22.22"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"35.00","spread":"48.545"},{"groupId":"OG001","value":"22.75","spread":"22.01"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"12.00","spread":"10.82"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"33.67","spread":"49.66"},{"groupId":"OG001","value":"19.50","spread":"20.24"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"12.33","spread":"21.36"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.50","spread":"1.00"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"15.33","spread":"26.56"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"14.00","spread":"24.25"},{"groupId":"OG001","value":"0.25","spread":"0.50"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"32.33","spread":"50.06"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"31.00","spread":"48.59"},{"groupId":"OG001","value":"3.00","spread":"4.24"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"9.00","spread":"15.59"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"14.33","spread":"24.83"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"24.00","spread":"41.57"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"29.67","spread":"47.96"},{"groupId":"OG001","value":"0.50","spread":"1.00"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"13.33","spread":"23.09"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"12.00","spread":"20.78"},{"groupId":"OG001","value":"2.00","spread":"2.45"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"13.67","spread":"23.67"},{"groupId":"OG001","value":"0.75","spread":"1.50"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"3.00","spread":"5.20"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"15.33","spread":"26.56"},{"groupId":"OG001","value":"3.50","spread":"5.74"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"5.00","spread":"6.24"},{"groupId":"OG001","value":"1.00","spread":"2.00"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"4.67","spread":"8.08"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"29.00","spread":"50.23"},{"groupId":"OG001","value":"11.00","spread":"18.74"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"3.75","spread":"3.77"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"28.33","spread":"49.07"},{"groupId":"OG001","value":"11.75","spread":"16.50"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"3.67","spread":"6.35"},{"groupId":"OG001","value":"2.00","spread":"4.00"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"25.00","spread":"43.30"},{"groupId":"OG001","value":"23.00","spread":"23.17"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"36.00","spread":"54.74"},{"groupId":"OG001","value":"18.00","spread":"23.19"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"33.33","spread":"57.74"},{"groupId":"OG001","value":"23.75","spread":"23.89"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"14.67","spread":"25.40"},{"groupId":"OG001","value":"9.50","spread":"16.44"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"5.33","spread":"9.24"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"33.00","spread":"52.83"},{"groupId":"OG001","value":"17.25","spread":"18.19"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"32.67","spread":"55.72"},{"groupId":"OG001","value":"23.75","spread":"23.30"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"27.33","spread":"47.34"},{"groupId":"OG001","value":"10.75","spread":"21.50"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"27.00","spread":"46.77"},{"groupId":"OG001","value":"15.75","spread":"16.58"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"25.33","spread":"43.88"},{"groupId":"OG001","value":"20.25","spread":"18.37"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"4.67","spread":"8.08"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"24.67","spread":"41.86"},{"groupId":"OG001","value":"20.75","spread":"18.39"}]}]}]},{"type":"SECONDARY","title":"Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.","description":"Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters","timeFrame":"Daily over approximately 1 week of inpatient stay.","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Sluggish/Fatigued/Lazy","categories":[{"measurements":[{"groupId":"OG000","value":"6.67","spread":"11.55"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Restless","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"1.25","spread":"1.89"}]}]},{"title":"Nervous/Anxious","categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.58"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Nauseated/Queasy/Sick to Stomach","categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Talkative/Friendly","categories":[{"measurements":[{"groupId":"OG000","value":"29.33","spread":"50.23"},{"groupId":"OG001","value":"18.25","spread":"31.94"}]}]},{"title":"Irregular/Racing Heartbeat","categories":[{"measurements":[{"groupId":"OG000","value":"30.67","spread":"53.12"},{"groupId":"OG001","value":"1.00","spread":"2.00"}]}]},{"title":"Euphoric","categories":[{"measurements":[{"groupId":"OG000","value":"32.33","spread":"56.00"},{"groupId":"OG001","value":"18.00","spread":"35.34"}]}]},{"title":"Shaky/Jittery","categories":[{"measurements":[{"groupId":"OG000","value":"2.00","spread":"3.46"},{"groupId":"OG001","value":"0.25","spread":"0.50"}]}]},{"title":"Active/Alert/Energetic","categories":[{"measurements":[{"groupId":"OG000","value":"37.33","spread":"53.46"},{"groupId":"OG001","value":"21.50","spread":"29.92"}]}]},{"title":"Will Pay For","categories":[{"measurements":[{"groupId":"OG000","value":"34.00","spread":"57.17"},{"groupId":"OG001","value":"18.75","spread":"32.31"}]}]},{"title":"Will Take Again","categories":[{"measurements":[{"groupId":"OG000","value":"37.67","spread":"54.04"},{"groupId":"OG001","value":"21.50","spread":"30.49"}]}]},{"title":"Performance Improved","categories":[{"measurements":[{"groupId":"OG000","value":"22.00","spread":"33.05"},{"groupId":"OG001","value":"18.75","spread":"33.00"}]}]},{"title":"Performance Impaired","categories":[{"measurements":[{"groupId":"OG000","value":"10.33","spread":"17.90"},{"groupId":"OG001","value":"13.50","spread":"27.00"}]}]},{"title":"Stimulated","categories":[{"measurements":[{"groupId":"OG000","value":"36.00","spread":"53.73"},{"groupId":"OG001","value":"20.25","spread":"32.57"}]}]},{"title":"Like Drug","categories":[{"measurements":[{"groupId":"OG000","value":"36.33","spread":"54.31"},{"groupId":"OG001","value":"21.50","spread":"31.72"}]}]},{"title":"Rush","categories":[{"measurements":[{"groupId":"OG000","value":"35.67","spread":"53.35"},{"groupId":"OG001","value":"2.50","spread":"5.00"}]}]},{"title":"High","categories":[{"measurements":[{"groupId":"OG000","value":"37.00","spread":"54.03"},{"groupId":"OG001","value":"20.25","spread":"27.89"}]}]},{"title":"Good Effects","categories":[{"measurements":[{"groupId":"OG000","value":"39.00","spread":"53.23"},{"groupId":"OG001","value":"20.25","spread":"27.93"}]}]},{"title":"Bad Effects","categories":[{"measurements":[{"groupId":"OG000","value":"9.67","spread":"16.74"},{"groupId":"OG001","value":"0.00","spread":"0.00"}]}]},{"title":"Any Effect","categories":[{"measurements":[{"groupId":"OG000","value":"38.00","spread":"53.11"},{"groupId":"OG001","value":"19.25","spread":"24.78"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Attentional Bias","description":"Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to \"no-go\" targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Proportion of Responses","timeFrame":"12 sessions over approximately 4.5 weeks","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methylphenidate (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0.07","spread":"0.08"},{"groupId":"OG001","value":"0.08","spread":"0.07"}]}]},{"title":"Methylphenidate (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0.04","spread":"0.04"},{"groupId":"OG001","value":"0.13","spread":"0.09"}]}]},{"title":"Methylphenidate (40mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.04"},{"groupId":"OG001","value":"0.11","spread":"0.05"}]}]},{"title":"Methylphenidate (60mg)","categories":[{"measurements":[{"groupId":"OG000","value":"0.12","spread":"0.11"},{"groupId":"OG001","value":"0.12","spread":"0.06"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)","description":"A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a Scale","timeFrame":"4 times over approximately 4.5 weeks","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methylphenidate (0 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"44.33","spread":"8.33"},{"groupId":"OG001","value":"51.25","spread":"6.60"}]}]},{"title":"Methylphenidate (20 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"44.00","spread":"3.46"},{"groupId":"OG001","value":"52.75","spread":"4.72"}]}]},{"title":"Methylphenidate (40 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"44.33","spread":"5.51"},{"groupId":"OG001","value":"54.00","spread":"2.45"}]}]},{"title":"Methylphenidate (60 mg)","categories":[{"measurements":[{"groupId":"OG000","value":"44.67","spread":"5.88"},{"groupId":"OG001","value":"53.00","spread":"6.00"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Delay Discounting for Methamphetamine","description":"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered \"now\" or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \\[e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later\\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"log(k)","timeFrame":"4 sessions over approximately 4.5 weeks","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methylphenidate (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.40","spread":"1.63"},{"groupId":"OG001","value":"-1.31","spread":"0.72"}]}]},{"title":"Methylphenidate (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.04","spread":"1.10"},{"groupId":"OG001","value":"-1.27","spread":"0.49"}]}]},{"title":"Methylphenidate (40mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.45","spread":"1.63"},{"groupId":"OG001","value":"-1.15","spread":"0.33"}]}]},{"title":"Methylphenidate (60mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.17","spread":"1.91"},{"groupId":"OG001","value":"-1.04","spread":"0.43"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Delay Discounting for Money","description":"Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered \"now\" or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \\[e.g., smaller sum of money given now as opposed to a larger sum given later\\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"log(k)","timeFrame":"4 sessions over approximately 4.5 weeks","groups":[{"id":"OG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules."},{"id":"OG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Methylphenidate (0mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.40","spread":"1.63"},{"groupId":"OG001","value":"-1.29","spread":"0.76"}]}]},{"title":"Methylphenidate (20mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.40","spread":"1.63"},{"groupId":"OG001","value":"-1.37","spread":"0.58"}]}]},{"title":"Methylphenidate (40mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.45","spread":"1.63"},{"groupId":"OG001","value":"-1.15","spread":"0.33"}]}]},{"title":"Methylphenidate (60mg)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.48","spread":"1.43"},{"groupId":"OG001","value":"-1.04","spread":"0.43"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0.29","timeFrame":"Assessed during 4.5 weeks of inpatient study.","eventGroups":[{"id":"EG000","title":"Placebo Comparator: Placebo","description":"Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.","deathsNumAffected":0,"deathsNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":2,"otherNumAtRisk":3},{"id":"EG001","title":"Active Comparator: Duloxetine (60 mg)","description":"Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.\n\nMethamphetamine: In each arm, subjects will receive doses of methamphetamine.\n\nMethylphenidate: In each arm, subjects will receive methylphenidate capsules.\n\nPlacebo oral capsule: In each arm, subjects will receive placebo capsules.\n\nDuloxetine: Subjects will receive duloxetine capsules in the duloxetine arm.","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":2,"otherNumAtRisk":4}],"otherEvents":[{"term":"Elevated Heart Rate","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":3},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":4}]},{"term":"Elevated Blood Pressure","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":3},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":4}]},{"term":"Migraine","organSystem":"Vascular disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":3},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":4}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Craig Rush, Ph.D.","organization":"University of Kentucky","email":"crush2@uky.edu","phone":"8592575388"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP_ICF","hasProtocol":true,"hasSap":true,"hasIcf":true,"label":"Study Protocol, Statistical Analysis Plan, and Informed Consent Form","date":"2019-07-08","uploadDate":"2022-11-15T08:30","filename":"Prot_SAP_ICF_001.pdf","size":11334146}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D008694","term":"Methamphetamine"},{"id":"D008774","term":"Methylphenidate"},{"id":"D007785","term":"Lactose"},{"id":"D000068736","term":"Duloxetine Hydrochloride"}],"ancestors":[{"id":"D000662","term":"Amphetamines"},{"id":"D010627","term":"Phenethylamines"},{"id":"D005021","term":"Ethylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D010648","term":"Phenylacetates"},{"id":"D000146","term":"Acids, Carbocyclic"},{"id":"D002264","term":"Carboxylic Acids"},{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D004187","term":"Disaccharides"},{"id":"D009844","term":"Oligosaccharides"},{"id":"D011134","term":"Polysaccharides"},{"id":"D002241","term":"Carbohydrates"},{"id":"D000073893","term":"Sugars"},{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"}]}},"hasResults":true}