Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01135602
Status:
UNKNOWN
Last Update Posted:
2011-08-15
First Post:
2010-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-11', 'releaseDate': '2014-07-21'}], 'estimatedResultsFirstSubmitDate': '2014-07-21'}}, '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': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-12', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '12 weeks', 'description': 'Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)'}], 'secondaryOutcomes': [{'measure': 'Alcohol drink/day', 'timeFrame': '12 weeks', 'description': 'Alcohol drink/day assessed by the use of Timeline Followback (TLFB)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol dependence', 'Alcoholism', 'Topiramate'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': '12-week, open-label study of topiramate in hospitalized patients with alcoholism'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized due to alcohol-related problems\n* DSM-IV-TR alcohol dependence\n* \\>/= 35 drinks/week (male) or \\>/= 28 drinks/week (female) for \\>/= 1 week during four weeks prior to the admission\n* AUDIT score \\>/= 8\n* Mild or no alcohol withdrawal\n* Body mass index \\> 18 kg/m2\n* No pregnancy and no plan for pregnancy (female)\n* Intention to decrease or stop drinking\n\nExclusion Criteria:\n\n* Severe psychiatric and cognitive disorders\n* Other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment\n* Taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram\n* Moderate to high risk of suicide\n* Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures\n* Unstable medical conditions\n* Plan to receive a formal treatment for alcoholism from other treatment settings\n* Under legal process\n* Pregnancy and nursing woman\n* Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar'}, 'identificationModule': {'nctId': 'NCT01135602', 'acronym': 'THoPA-O', 'briefTitle': 'Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study', 'orgStudyIdInfo': {'id': 'THoPA-O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topiramate', 'description': '1 group', 'interventionNames': ['Drug: Topiramate']}], 'interventions': [{'name': 'Topiramate', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'Topiramate 50-300 mg/day Orally Twice per day', 'armGroupLabels': ['Topiramate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Muang', 'state': 'Chiang Mai', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Manit Srisurapanont, MD', 'role': 'CONTACT', 'email': 'msrisu@yahoo.com', 'phone': '6653945422'}, {'name': 'Pichai Sangchanchai, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maharaj Nakorn Chiang Mai Hospital'}, {'zip': '50200', 'city': 'Muang', 'state': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Manit Srisurapanont, MD', 'role': 'CONTACT', 'email': 'msrisu@yahoo.com', 'phone': '+66-53-945422'}, {'name': 'Manit Srisurapanont, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maharaj Nakorn Chiang Mai Hospital'}], 'centralContacts': [{'name': 'Manit Srisurapanont, MD', 'role': 'CONTACT', 'email': 'msrisu@yahoo.com', 'phone': '6653945422'}], 'overallOfficials': [{'name': 'Manit Srisurapanont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Manit Srisurapanont', 'oldOrganization': 'Department of Psychiatry, Faculty of Medicine, Chiang Mai University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-07-21', 'type': 'RELEASE'}, {'date': '2014-08-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Manit Srisurapanont, Department of Psychiatry, Chiang Mai University'}}}}