Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT01722435
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2012-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Completion of OST - a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D058850', 'term': 'Opiate Substitution Treatment'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reimer@uke.de', 'phone': '+4940741057900', 'title': 'Prof. Dr. Jens reimer', 'organization': 'Centre for Interdisciplinary Addiction research of Hamburg University ZIS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OST Completers', 'description': 'Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment', 'otherNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Completion of OST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OST Completers', 'description': 'Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'OST Drop-outs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OST Completers', 'description': 'Patients who are likely to complete OST during the next 12 or 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Participants dropped out of OST Treatment during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Time to Complete OST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OST Completers', 'description': 'Patients completed OST during 12 or 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'spread': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Time to Drop-out of OST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OST Drop-outs', 'description': 'Patients dropped out of OST during 12 or 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '315', 'spread': '195', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) until drop-out of treatment.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Time Staying in OST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Still in OST Completers', 'description': 'Patients still in OST during the whole study period.'}], 'classes': [{'categories': [{'measurements': [{'value': '549', 'spread': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OST Completers', 'description': 'Patients who are likely to complete OST during the next 12 or 18 months\n\nOpiate Substitution Treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OST Completers', 'description': "The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period).\n\nAt the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lengths of OST before study entry', 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'spread': '59.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participants on specific medication', 'classes': [{'title': 'd,l-methadone', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'levometahdone', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'buprenorphine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average dose of medication taken', 'classes': [{'title': 'd,l-methadone', 'categories': [{'measurements': [{'value': '54.8', 'spread': '41.8', 'groupId': 'BG000'}]}]}, {'title': 'levomethadone', 'categories': [{'measurements': [{'value': '26.6', 'spread': '21.6', 'groupId': 'BG000'}]}]}, {'title': 'buprenorphine', 'categories': [{'measurements': [{'value': '14.3', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligrams', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients treated with methadone or levomethadone who were eligible for the study and consented to participate and qualified for treatment completion in the next 12 months.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2012-11-02', 'resultsFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2012-11-02', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-05', 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of OST', 'timeFrame': '18 months', 'description': 'Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.'}, {'measure': 'OST Drop-outs', 'timeFrame': '18 months', 'description': 'Participants dropped out of OST Treatment during the study period.'}], 'secondaryOutcomes': [{'measure': 'Mean Time to Complete OST', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).'}, {'measure': 'Mean Time to Drop-out of OST', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) until drop-out of treatment.'}, {'measure': 'Mean Time Staying in OST', 'timeFrame': '18 months', 'description': 'Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid dependence', 'opiate substitution treatment', 'methadone', 'completion', 'termination'], 'conditions': ['Opioid Dependence']}, 'descriptionModule': {'briefSummary': "Only limited information on the process of completing long-term opiate substitution treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt \\& Stohler (2006) show an estimated rate of 10% of patients per year who terminate OST by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. It is state of the art that an indication for termination of OST has to be based on a common agreement between the patient and the doctor. Furthermore, the patient should live in a stable social situation and the state of health had markedly improved. Finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (Vader et al. 2003).\n\nThe main objective of the prospective and explorative study is the systematic description of the process of termination of OST. With a comparison between patients who complete OST regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of OST can be identified.\n\nPatients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate OST during the next 12 months from the doctors' perspective can take part in the study. In addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires include state of health, well-being, social situation as well as drug and alcohol use. Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples).\n\nPatients who will be successful in completing OST during the observational period will be compared with the remaining cases.\n\nFinally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* opioid dependence according ICD-10\n* Minimum age of 18 years\n* In OST with methadone or levomethadone\n* Expected or planned treatment completion during the next 12 months\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with planned hospitalisation during the next 12 months\n* Patients who are likely or it is save to assume that they will be incarcerated or imprisoned during the next 12 months\n* Disability to take part in the study or follow the study conditions'}, 'identificationModule': {'nctId': 'NCT01722435', 'briefTitle': 'Completion of OST - a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study', 'orgStudyIdInfo': {'id': 'ZIS-OST-PV3718'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OST completers', 'description': 'Patients who are likely to complete OST during the next 12 or 18 months', 'interventionNames': ['Drug: Opiate Substitution Treatment']}], 'interventions': [{'name': 'Opiate Substitution Treatment', 'type': 'DRUG', 'armGroupLabels': ['OST completers']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jens Reimer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Interdisciplinary Addiction Research of Hamburg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asklepios Kliniken Hamburg GmbH', 'class': 'OTHER'}, {'name': 'Dr. Rainer Ullmann', 'class': 'UNKNOWN'}, {'name': 'Dr. Sibylle Quellhorst', 'class': 'UNKNOWN'}, {'name': 'Dr. Jochen Brack', 'class': 'UNKNOWN'}, {'name': 'Michael Klemperer', 'class': 'UNKNOWN'}, {'name': 'Gesine Hoeft', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. med. Jens Reimer', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}