Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00000320
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
1999-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 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'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], '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'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '1999-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood level', 'timeFrame': 'across study duration'}], 'secondaryOutcomes': [{'measure': 'drug use', 'timeFrame': 'across study duration'}, {'measure': 'craving', 'timeFrame': 'across study duration'}, {'measure': 'withdrawal symptoms', 'timeFrame': 'across study duration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid dependence'], 'conditions': ['Opioid-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."', 'detailedDescription': '1\\) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nM/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.\n\nExclusion Criteria:\n\nPregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.'}, 'identificationModule': {'nctId': 'NCT00000320', 'briefTitle': 'Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution', 'orgStudyIdInfo': {'id': 'NIDA-10068-1'}, 'secondaryIdInfos': [{'id': 'R01-10068-1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1; liquid formulation', 'description': 'liquid formulation', 'interventionNames': ['Drug: Buprenorphine formulation: liquid vs. tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2; tablet formulation', 'description': 'tablet formulation', 'interventionNames': ['Drug: Buprenorphine formulation: liquid vs. tablet']}], 'interventions': [{'name': 'Buprenorphine formulation: liquid vs. tablet', 'type': 'DRUG', 'otherNames': ['Subutex', 'Suboxone'], 'description': 'random assignment to liquid buprenorphine or tablet buprenorphine', 'armGroupLabels': ['1; liquid formulation', '2; tablet formulation']}]}, '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': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Walter Ling, M.D.', 'oldOrganization': 'Friends Research Institute'}}}}