Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 2:47 AM
Study NCT ID:
NCT01160432
Status:
WITHDRAWN
Last Update Posted:
2013-07-04
First Post:
2010-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naloxone Methadone Combination (NAMEKO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}], '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': 'D008691', 'term': 'Methadone'}, {'id': 'D009270', 'term': 'Naloxone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-03', 'studyFirstSubmitDate': '2010-07-09', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)', 'timeFrame': '1/2 hours after the first intake of medicine every week', 'description': 'COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).'}], 'secondaryOutcomes': [{'measure': 'The effectiveness of treatment (Treatment Outcomes Profile TOP)', 'timeFrame': 'Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.', 'description': 'Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opiate dependence', 'methadone', 'naloxone', 'withdrawal symptom', 'substitution treatment'], 'conditions': ['Opiate Dependence']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.\n\nStudy hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* opioid dependence\n* methadone treatment\n* no changes in methadone dose during the last 10 days\n* good treatment compliance according to doctor\n* normal ALAT and AFOS values (increased if double the normal level)\n\nExclusion Criteria:\n\n* severe renal or hepatic failure\n* acute psychosis\n* age under 18\n* pregnancy\n* legal incompetence\n* severe somatic disease\n* chaotic situation in life\n* medication or disease which is contraindication to study treatment'}, 'identificationModule': {'nctId': 'NCT01160432', 'acronym': 'NAMEKO', 'briefTitle': 'Naloxone Methadone Combination (NAMEKO)', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment', 'orgStudyIdInfo': {'id': 'KUH5703433'}, 'secondaryIdInfos': [{'id': '2010-021814-43', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone naloxone combination product 2/0,04 mg/ml', 'description': 'Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml', 'interventionNames': ['Drug: Methadone, naloxone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methadone 2 mg/ml', 'description': 'Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).', 'interventionNames': ['Drug: Methadone, naloxone']}], 'interventions': [{'name': 'Methadone, naloxone', 'type': 'DRUG', 'otherNames': ['Methadone Martindale Pharma'], 'description': "Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml daily according to patient's individual dose. At first open label pilot using single (individual) dosage for 2 patients. After that crossover study using methadone 2 mg/ml in combination with naloxone 0,04 mg/ml compared to methadone 2 mg/ml alone in one week's periods for four weeks.", 'armGroupLabels': ['Methadone 2 mg/ml', 'Methadone naloxone combination product 2/0,04 mg/ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Ulrich Tacke, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital, University of Eastern Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, docent', 'investigatorFullName': 'Ulrich Tacke', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}