Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-04-10 @ 12:25 AM
Study NCT ID:
NCT00984360
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Naltrexone for Methamphetamine Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C000624616', 'term': 'vivitrol'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2009-09-14', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MA (-) Urine Samples', 'timeFrame': 'Twice weekly for 5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Meth', 'Methamphetamine Addiction', 'Methamphetamine Treatment', 'Naltrexone', 'Vivitrol', 'A118G', 'OPRM1'], 'conditions': ['Methamphetamine Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 50 years\n* Patient is agreeable to conditions of study and signs consent form'}, 'identificationModule': {'nctId': 'NCT00984360', 'briefTitle': 'Study of Naltrexone for Methamphetamine Addiction', 'organization': {'class': 'OTHER', 'fullName': 'California Pacific Medical Center Research Institute'}, 'officialTitle': 'A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP', 'orgStudyIdInfo': {'id': '1R01DA027161-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA027161-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A118G', 'interventionNames': ['Drug: Naltrexone']}, {'type': 'EXPERIMENTAL', 'label': 'Wild-type', 'interventionNames': ['Drug: Naltrexone']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'otherNames': ['Vivitrol', 'Vivitrex'], 'description': '380mg extended-release, given once by intramuscular gluteal injection', 'armGroupLabels': ['A118G', 'Wild-type']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Addiction & Pharmacology Research Laboratory', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John Mendelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Pacific Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Pacific Medical Center Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'John Mendelson, MD', 'investigatorAffiliation': 'California Pacific Medical Center Research Institute'}}}}