Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00310934
Status:
COMPLETED
Last Update Posted:
2006-10-24
First Post:
2006-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Stepwise Strategy Utilizing Buprenorphine and Methadone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006556', 'term': 'Heroin Dependence'}], 'ancestors': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'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'}, {'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D055502', 'term': 'Secondary Prevention'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2006-10-23', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2006-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention in treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion urine samples free of illicit drugs'}, {'measure': 'Problem severity as measured by Addiction Severity Index'}]}, 'conditionsModule': {'keywords': ['heroin dependence', 'methadone', 'buprenorphine', 'contingency management', 'relapse prevention'], 'conditions': ['Heroin Dependence']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.', 'detailedDescription': 'The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.\n\nFor this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heroin dependence according to DSM IV \\> 1year\n* Age \\> 20 years\n* Acceptance of the stated treatment principles.\n\nExclusion Criteria:\n\n* Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent\n* Other clinically significant psychiatric illness unless stable under treatment\n* Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease\n* Other clinically significant medical condition unless stable under treatment\n* Treatment with anti-seizure drugs or disulfiram\n* Pregnancy or intent to become pregnant within the next year\n* Ongoing nursing\n* Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible."}, 'identificationModule': {'nctId': 'NCT00310934', 'briefTitle': 'A Stepwise Strategy Utilizing Buprenorphine and Methadone', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Graded Strategy for Pharmacological Treatment of Heroin Dependence', 'orgStudyIdInfo': {'id': 'KarolinskaUH Regional 373/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'methadone', 'type': 'DRUG'}, {'name': 'buprenorphine / methadone sequence', 'type': 'DRUG'}, {'name': 'Relapse prevention', 'type': 'BEHAVIORAL'}, {'name': 'Contingency management', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Dept of Clinical Neuroscience, Karolinska Inst', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Markus Heilig, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institute, Stockholm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish National Drug Policy Coordinator', 'class': 'UNKNOWN'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Schering-Plough', 'class': 'INDUSTRY'}]}}}