Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT00829634
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2009-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405765', 'term': 'N-myristoyl-alaninol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum samples', 'timeFrame': 'Predose and Multiple Timepoints Post Doses'}, {'measure': 'Urine Samples', 'timeFrame': '24 Hour Inpatient Collection'}], 'secondaryOutcomes': [{'measure': 'Questionnaries', 'timeFrame': 'Predose and Multiple Timepoints Post Doses'}]}, 'conditionsModule': {'keywords': ['methamphetamine', 'inpatient', 'd-MA', 'l-MA', 'APRL', 'San Francisco', 'metabolism', 'Metabolism of methamphetamine'], 'conditions': ['Nasal Congestion']}, 'descriptionModule': {'briefSummary': 'The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.', 'detailedDescription': "Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.\n\nOnce enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw.\n\nDuring the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Males and Females Between the Ages of 18 and 50\n* Must have some experience with methamphetamine'}, 'identificationModule': {'nctId': 'NCT00829634', 'briefTitle': 'Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation', 'organization': {'class': 'OTHER', 'fullName': 'California Pacific Medical Center Research Institute'}, 'orgStudyIdInfo': {'id': '27.092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'l-methamphetamine', 'interventionNames': ['Drug: l-methamphetamine', 'Drug: d-methamphetamine']}], 'interventions': [{'name': 'l-methamphetamine', 'type': 'DRUG', 'otherNames': ['l-MA'], 'description': '5mg of l-methamphetamine per day throughout the 2 week study', 'armGroupLabels': ['l-methamphetamine']}, {'name': 'd-methamphetamine', 'type': 'DRUG', 'otherNames': ['d-MA'], 'description': '15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13', 'armGroupLabels': ['l-methamphetamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'CPMC Addiction & Pharmacology Research Laboratory (APRL)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Pacific Medical Center Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco General Hospital', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'John Mendelson, MD', 'investigatorAffiliation': 'California Pacific Medical Center Research Institute'}}}}