Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-28 @ 2:28 AM
Study NCT ID:
NCT00344812
Status:
COMPLETED
Last Update Posted:
2006-06-27
First Post:
2006-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Maintenance Medications Comparison Study
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': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '1998-06'}, 'lastUpdateSubmitDate': '2006-06-26', 'studyFirstSubmitDate': '2006-06-26', 'studyFirstSubmitQcDate': '2006-06-26', 'lastUpdatePostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study retention'}, {'measure': 'Drug use'}], 'secondaryOutcomes': [{'measure': 'Safety'}]}, 'conditionsModule': {'conditions': ['Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '11058673', 'type': 'RESULT', 'citation': 'Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.'}]}, 'descriptionModule': {'briefSummary': 'A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* age 21 to 55 years\n* diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)\n* evidence of recent opioid use on toxicologic screening\n\nExclusion\n\n* serious medical or psychiatric illness requiring long-term medication\n* positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT00344812', 'briefTitle': 'Opioid Maintenance Medications Comparison Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'orgStudyIdInfo': {'id': 'BPR-95-07-24-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LAAM. buprenorphine and methadone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Rolley E Johnson, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}}}}