Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00874003
Status:
COMPLETED
Last Update Posted:
2009-04-02
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
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': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-01', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol consumption measured by alcohol diary (units/week).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alcohol dependence', 'anti-depressant', '5-HT', 'NE'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* male sex\n* alcohol high consumption\n* signed informed consent\n\nExclusion Criteria:\n\n* psychiatric disorders (except nicotine and alcohol dependence)\n* severe somatic disorders\n* inadequate knowledge of the Swedish language'}, 'identificationModule': {'nctId': 'NCT00874003', 'briefTitle': 'The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GOTABU-BO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mirtazapine, tablet, 30 mg', 'description': 'n=29', 'interventionNames': ['Drug: mirtazapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill', 'description': 'n=30', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'mirtazapine', 'type': 'DRUG', 'description': 'oral tablet, 30 mg daily', 'armGroupLabels': ['mirtazapine, tablet, 30 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral tablet, 1 daily', 'armGroupLabels': ['sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Addiction Biology Unit', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Andrea deBejczy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Addiction Biology Unit'}, {'name': 'Bo Söderpalm, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addiction Biology Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bo Söderpalm/ MD, PhD, sponsor', 'oldOrganization': 'Addiction Biology Unit, Sahlgrenska University Hospital, Sweden'}}}}