Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT00300794
Status:
COMPLETED
Last Update Posted:
2006-11-14
First Post:
2006-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2006-11-13', 'studyFirstSubmitDate': '2006-03-07', 'studyFirstSubmitQcDate': '2006-03-07', 'lastUpdatePostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '16401957', 'type': 'RESULT', 'citation': 'Ivaskevicius J, Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R. [Safety and effectiveness of opiate antagonist detoxification under general anesthesia]. Medicina (Kaunas). 2005;41(12):1011-8. Lithuanian.'}, {'pmid': '16963828', 'type': 'RESULT', 'citation': 'Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R, Ivaskevicius J. Effects of ketamine on precipitated opiate withdrawal. Medicina (Kaunas). 2006;42(8):625-34.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed opiate dependence according to ICD 10 and/or DSM 4;\n* Duration of substance abuse more than 1 year\n* No or minor co-morbidities;\n* Grade I-II according to physical status classification system of American Society of Anesthesiologists.\n\nExclusion Criteria:\n\n* Current history of long acting opiate or poly-substance abuse;\n* Acute medical or surgical condition;\n* Pregnancy;\n* Breastfeeding.'}, 'identificationModule': {'nctId': 'NCT00300794', 'briefTitle': 'Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'orgStudyIdInfo': {'id': 'PROT N1 V1_5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ketamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Emergency Hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Juozas Ivaskevicius, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vilnius University Clinic of Anaesthesiology and Intensive Care'}, {'name': 'Tomas Jovaisa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University Clinic of Anaesthesiology and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}}}}