Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00000205
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
1999-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buprenorphine Maintenance Protocol - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 0}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1990-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '1993-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1993-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention'}, {'measure': 'Opiate use'}, {'measure': 'Opiate craving'}, {'measure': 'Adverse events'}]}, 'conditionsModule': {'conditions': ['Opioid-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '8624183', 'type': 'BACKGROUND', 'citation': 'Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.'}, {'pmid': '8555282', 'type': 'BACKGROUND', 'citation': 'Compton PA, Ling W, Charuvastra VC, Wesson DR. Buprenorphine as a pharmacotherapy for cocaine abuse: a review of the evidence. J Addict Dis. 1995;14(3):97-114. doi: 10.1300/J069v14n03_07.'}, {'pmid': '8704003', 'type': 'BACKGROUND', 'citation': 'Compton PA, Ling W, Wesson DR, Charuvastra VC, Wilkins J. Urine toxicology as an outcome measure in drug abuse clinical trials: must every sample be analyzed? J Addict Dis. 1996;15(2):85-92. doi: 10.1300/J069v15n02_07.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of buprenorphine versus methadone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nM/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.\n\nExclusion Criteria:\n\nPsychiatric disorder that requires medication therapy. History of seizures. Pregnant and /or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe'}, 'identificationModule': {'nctId': 'NCT00000205', 'briefTitle': 'Buprenorphine Maintenance Protocol - 1', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Buprenorphine Maintenance Protocol', 'orgStudyIdInfo': {'id': 'NIDA-06082-1'}, 'secondaryIdInfos': [{'id': 'R18DA006082', 'link': 'https://reporter.nih.gov/quickSearch/R18DA006082', 'type': 'NIH'}, {'id': 'R18-06082-1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Friends Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Walter Ling, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}