Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT00521157
Status:
COMPLETED
Last Update Posted:
2009-05-05
First Post:
2007-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-04', 'studyFirstSubmitDate': '2007-08-24', 'studyFirstSubmitQcDate': '2007-08-24', 'lastUpdatePostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug use at 6 (12) months by self report and hair analysis', 'timeFrame': '6 and 12 months'}, {'measure': 'Days in work or education', 'timeFrame': '6 and 12 months'}, {'measure': 'Number of drug-free friends at 6 (12) months by self report', 'timeFrame': '6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Depression at 6 (12) months by BDI and Hopkins SCL-25', 'timeFrame': '6 and 12 months'}, {'measure': 'Quality of life at 6 (12) months by EuropASI', 'timeFrame': '6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Substance abuse', 'Opiate dependency', 'Treatment', 'Relapse prevention'], 'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '40342086', 'type': 'DERIVED', 'citation': 'Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.'}, {'pmid': '20707781', 'type': 'DERIVED', 'citation': 'Kunoe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen O, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. doi: 10.1111/j.1360-0443.2010.03031.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.\n\nThe hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.\n\nThe investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* soon to complete inpatient treatment for opioid addiction\n* living in southern Norway\n\nExclusion Criteria:\n\n* psychosis/major depression, currently not treated\n* pregnancy\n* liver enzymes: ASAT or ALAT \\> threefold above upper boundary\n* maintenance treatment with methadone or buprenorphine'}, 'identificationModule': {'nctId': 'NCT00521157', 'briefTitle': 'Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study', 'orgStudyIdInfo': {'id': '11899 revised'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Experimental group randomised after abstinence oriented treatment', 'interventionNames': ['Drug: Go Medical Naltrexone implants']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'waiting list control'}], 'interventions': [{'name': 'Go Medical Naltrexone implants', 'type': 'DRUG', 'otherNames': ['Go Medical naltrexone implant'], 'description': 'Naltrexone implants 3.2 g (double of 1,6 g)', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Unit for Addiction Medicine, University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Helge Waal, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unit for addiction medicine, Institute of psychiatry, University of Oslo'}, {'name': 'Helge Waal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian Medical Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Helge Waal, MD, Professor, Head of Center for Addiction Research, University of Oslo', 'oldOrganization': 'Institute of Psychiatry, University of Oslo'}}}}