Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT00435435
Status:
COMPLETED
Last Update Posted:
2007-02-16
First Post:
2007-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004221', 'term': 'Disulfiram'}, {'id': 'D000077443', 'term': 'Acamprosate'}], 'ancestors': [{'id': 'D004050', 'term': 'Ditiocarb'}, {'id': 'D013859', 'term': 'Thiocarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004220', 'term': 'Disulfides'}, {'id': 'D013440', 'term': 'Sulfides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013654', 'term': 'Taurine'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-02', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2007-02-15', 'studyFirstSubmitDate': '2007-02-14', 'studyFirstSubmitQcDate': '2007-02-14', 'lastUpdatePostDateStruct': {'date': '2007-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time(days) to first heavy drinking (HDD)day after medication started'}], 'secondaryOutcomes': [{'measure': 'Time (days) to first drinking after medication started'}, {'measure': 'Abstinence days (0 drinks/ day) by group'}, {'measure': 'Average alcohol intake (weekly by group)'}, {'measure': 'ALAT'}, {'measure': 'GGT'}, {'measure': 'SADD'}, {'measure': 'AUDIT'}, {'measure': 'EQ-5'}]}, 'conditionsModule': {'keywords': ['Alcoholism', 'Dependence', 'Randomization', 'Effect', 'Disulfiram', 'Naltrexone', 'Acamprosate'], 'conditions': ['Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '16968347', 'type': 'BACKGROUND', 'citation': 'Morley KC, Teesson M, Reid SC, Sannibale C, Thomson C, Phung N, Weltman M, Bell JR, Richardson K, Haber PS. Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial. Addiction. 2006 Oct;101(10):1451-62. doi: 10.1111/j.1360-0443.2006.01555.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.', 'detailedDescription': "Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.\n\nObjectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.\n\nDesign and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.\n\nParticipants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcohol dependence (ICD-10)\n\nExclusion Criteria:\n\n* Clinically significant symptoms of alcohol withdrawal\n* Significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview)\n* Current psychiatric disease demanding special treatment or medication including DSM-IV determined drug dependence other than alcohol or nicotine dependence\n* Current use of any opioids within four weeks before screening\n* Significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT \\> 200)\n* Pregnancy, nursing, or women refused to use a reliable method for birth control'}, 'identificationModule': {'nctId': 'NCT00435435', 'acronym': 'DNA', 'briefTitle': 'Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence', 'orgStudyIdInfo': {'id': 'KTL-175-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Disulfiram', 'type': 'DRUG'}, {'name': 'Acamprosate', 'type': 'DRUG'}, {'name': 'Naltexone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00251', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'National Public Health Institute, Department of Mental Health and Alcohol Research', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Hannu Alho, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Public Health Institute, Department of Mental health and Alcohol Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}}}}