Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05182918
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2021-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tobacco use', 'timeFrame': 'Approximately one year after admission to treatment (range 11 - 18 months)', 'description': 'Changes in tobacco use from baseline to follow-up'}, {'measure': 'Substance use', 'timeFrame': 'Approximately one year after admission to treatment (range 11 - 18 months)', 'description': 'Changes in substance use from baseline to follow-up. Excerpts from the European version were used to collect data on substance use. Substance use was scored for the previous 4 weeks on a 6-point response format were 0 corresponded to "No use" and 5 corresponded to "Daily use". 1 year follow-up were compared with baseline values.'}, {'measure': 'Somatic complaints.', 'timeFrame': 'Approximately one year after admission to treatment (range 11 - 18 months).', 'description': 'Changes in somatic complaints from baseline to follow-up. A checklist containing 16 somatic complaints common among chronic drug users, including major organ systems. Responses are provided on a 0 -4 response format, with 0 corresponding to "not at all", 1 "a little", 2 "moderately", 3 "a lot", and 4 "very much".'}], 'secondaryOutcomes': [{'measure': 'Mental distress', 'timeFrame': 'Approximately one year after admission to treatment (range 11 - 18 months)', 'description': 'Changes from baseline to post-treatment and follow-up. The Hopkins Symptom Checklist (HSCL) 25-item version was used to measure mental distress. Each of the 25 items was scored on a 5-point scale (0-4). An average score was computed, indicating a global severity index of mental distress (GSI).'}, {'measure': 'QoL (quality of life)', 'timeFrame': 'Approximately one year after admission to treatment (range 11 - 18 months)', 'description': 'Excerpts from the QoL10 will be used to assess QoL. The scale has 10 ordinal items and each item is scored from 1 = very poor up to 5 = very good. The scale is transformed to a decimal scale ranging from 0.1 to 0.9 and averaged, where 0.9 is the best QoL. A normative score in a population sample was 0.7.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders', 'Opioid Use Disorder', 'Tobacco Use', 'Health, Subjective', 'Mental Health Impairment']}, 'referencesModule': {'references': [{'pmid': '38790008', 'type': 'DERIVED', 'citation': 'Bjornestad ED, Vederhus JK, Clausen T. Change in substance use among patients in opioid maintenance treatment: baseline to 1-year follow-up. Harm Reduct J. 2024 May 24;21(1):101. doi: 10.1186/s12954-024-01005-x.'}, {'pmid': '38383345', 'type': 'DERIVED', 'citation': 'Bjornestad ED, Vederhus JK, Clausen T. Change in self-reported somatic symptoms among patients in opioid maintenance treatment from baseline to 1-year follow-up. BMC Psychiatry. 2024 Feb 21;24(1):149. doi: 10.1186/s12888-024-05590-w.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.\n\nThe study will use already collected data from the multi-center, longitudinal, observational NorComt study (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment study).\n\nNorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).', 'detailedDescription': 'The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.\n\nThe study will use already collected data from the multi-center, longitudinal, observational NorComt (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment) study.\n\nNorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).\n\nThe present doctoral research degree project is financed by the Southern and Eastern Norway Regional Health Authority, and hosted by Sørlandet hospital in collaboration with the Norwegian Centre for Addiction Research (SERAF).\n\nEthical approval for analysis of NorComt data and for the planned registry data linkages of NorComt data has been granted by the Norwegian Regional Ethics Committee (REK 2012/1131).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were included in the study from 21 participating treatment facilities across Norway, 14 were opioid maintenance treatment (OMT) outpatient centers, and 7 were inpatient centers (predominately non-OMT). Apart from an established opioid use disorder diagnosis there are no further criteria for entering OMT treatment, although generally substitution free treatment is recommended as a first option. In-patient SUD treatment represented in the present project typically has a duration of 6-9 months, primarily with non-OMT treatment in therapeutic community-like settings. Some patients would transfer to an outpatient treatment after completing in-patient treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admittance to a substance use disorder treatment facility, either standardized opioid maintenance treatment (OMT) or other substance use disorder treatment (in-patient)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05182918', 'acronym': 'AgeSUD', 'briefTitle': 'Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment', 'orgStudyIdInfo': {'id': '813485'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in OMT and other SUD treatment', 'description': 'Patients in opioid maintenance treatment and other substance use disorder treatment', 'interventionNames': ['Other: Substance use disorder treatment']}], 'interventions': [{'name': 'Substance use disorder treatment', 'type': 'OTHER', 'description': 'The study followed a heterogenous sample of patients in opioid maintenance treatment (OMT) and other substance use disorder treatment. The main focus was on health related problems in this cohort, with focus on tobacco use and substance use.', 'armGroupLabels': ['Patients in OMT and other SUD treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Kristiansand', 'state': 'Agder', 'country': 'Norway', 'facility': 'Addiction Unit - Sørlandet Hospital', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Thomas Clausen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Centre for Addiction Research, University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized data can be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}