Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT00603434
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2008-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the OROS-MPH concurrent with d-methamphetamine infusions.', 'timeFrame': 'Daily'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations', 'timeFrame': 'Screen, day 2, day 10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methamphetamine'], 'conditions': ['Methamphetamine Dependence', 'Methamphetamine Abuse']}, 'descriptionModule': {'briefSummary': 'This is a human inpatient clinical pharmacology study to assess potential interactions between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures include cardiovascular responses \\[heart rate (HR), blood pressure (BP), and electrocardiograph (ECG) measurements\\], oral temperature, adverse events (AEs), and clinical laboratory analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be volunteers who meet DSM-IV criteria for methamphetamine abuse or dependence determined using a Mini-International Neuropsychiatric Interview (MINI) and be non-treatment seeking at time of study and have a positive urine test for methamphetamine (greater than or = to 500 ng/mL) during screening.\n* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.\n* Have a negative urine test for methamphetamine and other drugs of abuse (opiates, cocaine, and benzodiazepines) after clinic intake before the first infusion session.\n* Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the site Principal Investigator\n* Have vital signs as follows: resting heart rate between 45 and 100 bpm, systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg.\n* Have electrolytes (Na, K, Cl, HCO3) and hematocrit that is clinically normal (+/- 10% of laboratory limits).\n* Have liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) less than three times the upper limit of normal.\n* Have kidney function tests (creatinine and BUN) less than twice the upper limit of normal.\n* Have an ECG performed that demonstrates sinus rhythm between 45 and 100 beats per minute (bpm), normal conduction, and no clinically significant arrhythmias.\n* Be able to swallow whole tablets of OROS-MPH due to the controlled release formulation.\n* If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized. Birth control must be in effect starting at least 7 days (14 days for hormone-based methods used alone) prior to clinic intake, and should extend at least until the last follow-up visit.\n\nExclusion Criteria:\n\n* Please contact site for more information'}, 'identificationModule': {'nctId': 'NCT00603434', 'briefTitle': 'Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)', 'orgStudyIdInfo': {'id': 'NIDA-CPU-Methylphenidate-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Osmotic-Release Methylphenidate', 'interventionNames': ['Drug: OROS-MPH']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Osmotic-Release Methylphenidate', 'interventionNames': ['Drug: OROS-MPH']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Osmotic-Release Methylphenidate', 'interventionNames': ['Drug: OROS-MPH']}], 'interventions': [{'name': 'OROS-MPH', 'type': 'DRUG', 'otherNames': ['Concerta'], 'description': '18 mg bid on days 1 and 2', 'armGroupLabels': ['1']}, {'name': 'OROS-MPH', 'type': 'DRUG', 'otherNames': ['Concerta'], 'description': '27mg bid on days 3 and 4', 'armGroupLabels': ['2']}, {'name': 'OROS-MPH', 'type': 'DRUG', 'otherNames': ['Concerta'], 'description': '35 mg bid on days 5-9', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Addiction Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': 'M5V2T3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ventana Clinical Research Corporation', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Eugene Somoza, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}, {'name': 'Edward Sellers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ventana Clinical Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Liza Gorgon', 'oldOrganization': 'NIDA'}}}}