Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-07 @ 4:34 PM
Study NCT ID:
NCT01182402
Status:
COMPLETED
Last Update Posted:
2011-03-22
First Post:
2010-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Compliance Monitoring in Opioid Substitution Treatment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-21', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-13', 'lastUpdatePostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of treatment (Treatment Outcomes Profile TOP)', 'timeFrame': 'Every two months.', 'description': 'Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.'}], 'secondaryOutcomes': [{'measure': 'Patients´opinions about the treatment.', 'timeFrame': 'Once when the study phase ends (after four months).', 'description': "Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on their treatment and abuse and/or diversion of medications."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opiate dependence', 'substitution treatment', 'unsupervised dosing', 'monitoring'], 'conditions': ['Opiate Dependence']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* opiate dependence F11.22 according to ICD-10\n* Suboxone treatment\n* the duration of substitution treatment before study at least one month\n* stable medication dose\n\nExclusion Criteria:\n\n* unstable situation in life according to treatment staff's opinions"}, 'identificationModule': {'nctId': 'NCT01182402', 'acronym': 'EHSO', 'briefTitle': 'Electronic Compliance Monitoring in Opioid Substitution Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Electronic Compliance Monitoring in Opioid Substitution Treatment', 'orgStudyIdInfo': {'id': 'KUH5703432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic compliance monitoring', 'description': 'Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.', 'interventionNames': ['Device: Compliance monitoring with electronic device']}], 'interventions': [{'name': 'Compliance monitoring with electronic device', 'type': 'DEVICE', 'description': 'Patients get all their unsupervised substitution medication doses in electronic monitoring devices during the study. Daily dose of the drug is possible to get from the device in given time points and in the meantime device is locked.', 'armGroupLabels': ['Electronic compliance monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Eastern Finland', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ulrich Tacke', 'oldOrganization': 'Kuopio University Hospital'}}}}