Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT00006205
Status:
UNKNOWN
Last Update Posted:
2013-03-15
First Post:
2000-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
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': 'D017294', 'term': 'Ondansetron'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2000-09-11', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption', 'timeFrame': 'Throughout the study', 'description': 'Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT'}], 'secondaryOutcomes': [{'measure': 'Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors', 'timeFrame': 'Throughout the study', 'description': 'Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcoholism', 'alcohol addiction'], 'conditions': ['Alcoholism']}, 'referencesModule': {'references': [{'pmid': '15330732', 'type': 'BACKGROUND', 'citation': 'Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.', 'detailedDescription': 'This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.\n* Provide a written, informed consent.\n* Good physical health and must weigh within at least 40 kg and no more than 140 kg.\n* Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.\n* Willingness to participate in behavioral treatments for alcoholism.\n* Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.\n\nExclusion Criteria:\n\nPlease contact site for additional information'}, 'identificationModule': {'nctId': 'NCT00006205', 'briefTitle': 'Alcohol Dependency Study: Combining Medication Treatment for Alcoholism', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Combining Medications Treatment for Alcoholism', 'orgStudyIdInfo': {'id': 'NIAAAJOH1052207A1'}, 'secondaryIdInfos': [{'id': 'R01AA013964', 'link': 'https://reporter.nih.gov/quickSearch/R01AA013964', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ondansetron', 'description': 'Ondansetron + cognitive behavioral therapy', 'interventionNames': ['Drug: ondansetron + cognitive behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Topiramate', 'description': 'Topiramate + cognitive behavioral therapy', 'interventionNames': ['Drug: topiramate + cognitive behavioral therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + cognitive behavioral therapy', 'interventionNames': ['Drug: Placebo + cognitive behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Ondansetron + Topiramate', 'description': 'Ondansetron + Topiramate + cognitive behavioral therapy', 'interventionNames': ['Drug: ondansetron + topiramate + cognitive behavioral therapy']}], 'interventions': [{'name': 'ondansetron + cognitive behavioral therapy', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'ondansetron (4 mcg/kg b.i.d)', 'armGroupLabels': ['Ondansetron']}, {'name': 'topiramate + cognitive behavioral therapy', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'topiramate (up to 300 mg/day)', 'armGroupLabels': ['Topiramate']}, {'name': 'Placebo + cognitive behavioral therapy', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'placebo', 'armGroupLabels': ['Placebo']}, {'name': 'ondansetron + topiramate + cognitive behavioral therapy', 'type': 'DRUG', 'otherNames': ['zofran, topamax'], 'description': 'ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)', 'armGroupLabels': ['Ondansetron + Topiramate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mindy Borszich', 'role': 'CONTACT', 'email': 'mcb3x@virginia.edu', 'phone': '888-882-2345'}, {'name': 'Eva Jenkins-Mendoza', 'role': 'CONTACT', 'email': 'emj9c@virginia.edu', 'phone': '(434)243-0562'}, {'name': 'Bankole Johnson, DSc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nassima Ait-Daoud Tiouririne, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Virginia Center for Addiction Research and Education', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mindy Borszich', 'role': 'CONTACT', 'email': 'mcb3x@virginia.edu', 'phone': '888-882-2345'}, {'name': 'Eva Jenkins-Mendoza', 'role': 'CONTACT', 'email': 'emj9c@virginia.edu', 'phone': '(434)243-0562'}, {'name': 'Bankole Johnson, DSc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nassima Ait-Daoud Tiouririne, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Virginia Center for Addiction Research and Education', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Mindy Borszich', 'role': 'CONTACT', 'email': 'mcb3x@virginia.edu', 'phone': '1-888-882-2345'}, {'name': 'Eva Jenkins-Mendoza', 'role': 'CONTACT', 'email': 'emj9c@virginia.edu', 'phone': '(434) 243-0562'}], 'overallOfficials': [{'name': 'Bankole Johnson, DSc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bankole Johnson', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair of Psychiatry and Neurobehavioral Sciences', 'investigatorFullName': 'Bankole Johnson', 'investigatorAffiliation': 'University of Virginia'}}}}