Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 11:01 AM
Study NCT ID:
NCT00678457
Status:
COMPLETED
Last Update Posted:
2009-01-30
First Post:
2008-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
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': 'D000077152', 'term': 'Olanzapine'}], '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': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, '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': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2008-05-08', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcohol dependence', 'alcohol abuse', 'drinking', 'alcohol'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.', 'detailedDescription': 'Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.\n\nThis is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females who have given written informed consent\n* Aged 18 years and above and weighing ≥40 kg and ≤140 kg\n* Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment\n* DSM-IV-R diagnosis of alcohol dependence\n* Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range\n* Negative pregnancy test at intake.\n* Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments\n* Willing to participate in behavioral treatments for alcoholism\n* Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking\n* Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months\n\nExclusion Criteria:\n\n* Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol\n* Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment\n* Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine\n* Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial\n* Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study\n* Received inpatient or outpatient treatment for alcohol dependence within the last 30 days\n* Significant medical illness (including hypertension) as determined by history and/or complete physical examination.\n* Gross neurological disease\n* Mental retardation\n* Pyrexia of unknown origin\n* Diagnosis or suspicion of Alzheimer's disease\n* Clinically significant abnormalities on the EKG that will preclude safe participation\n* Recent (last 3 months) history of ischemic heart disease or myocardial infarction.\n* Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.\n* Participation in a clinical study within the last 30 days\n* Elevation of liver enzymes\n* History of any severe or life-threatening reaction to olanzapine or ondansetron\n* Past or current history of seizures disorder\n* Past or current history of diabetes\n* Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®).\n* Pending imprisonment"}, 'identificationModule': {'nctId': 'NCT00678457', 'briefTitle': 'Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial', 'orgStudyIdInfo': {'id': 'TO45228'}, 'secondaryIdInfos': [{'id': 'IRB-HSR #12816'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ondansetron/olanzapine', 'description': 'ondansetron (4 μg/kg b.i.d.)\n\nolanzapine (9 μg/kg)', 'interventionNames': ['Drug: Ondansetron', 'Drug: Olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'ondansetron (4 μg/kg b.i.d.)', 'armGroupLabels': ['ondansetron/olanzapine']}, {'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'olanzapine (9, 18, and 36 μg/kg)', 'armGroupLabels': ['ondansetron/olanzapine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA CARE', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA CARE Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Bankole Johnson, DSc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bankole Johnson, DSc, M.D., Ph.D.', 'oldOrganization': 'University of Virginia'}}}}