Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 2:28 AM
Study NCT ID:
NCT00000206
Status:
COMPLETED
Last Update Posted:
2016-11-07
First Post:
1999-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Rescue Protocol - 2
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 0}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '1999-09-20', 'studyFirstSubmitQcDate': '1999-09-20', 'lastUpdatePostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention'}, {'measure': 'Opiate use'}, {'measure': 'Opiate craving'}, {'measure': 'Adverse events'}]}, 'conditionsModule': {'keywords': ['Opioid'], 'conditions': ['Opioid-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '9467800', 'type': 'BACKGROUND', 'citation': 'Ling W, Shoptaw S, Wesson D, Rawson RA, Compton M, Klett CJ. Treatment effectiveness score as an outcome measure in clinical trials. NIDA Res Monogr. 1997;175:208-20. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.'}, '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': 'NCT00000206', 'briefTitle': 'Clinical Rescue Protocol - 2', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Clinical Rescue Protocol', 'orgStudyIdInfo': {'id': 'NIDA-06082-2'}, 'secondaryIdInfos': [{'id': 'R18DA006082', 'link': 'https://reporter.nih.gov/quickSearch/R18DA006082', 'type': 'NIH'}, {'id': 'R18-06082-2'}]}, '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'}]}}}