Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-03-21 @ 5:46 PM
Study NCT ID:
NCT00595556
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2008-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000078305', 'term': 'Zonisamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alarias@uchc.edu', 'phone': '8606794423', 'title': 'Albert J. Arias, M.D.', 'phoneExt': '4423', 'organization': 'UCHC'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The small sample size and the short duration of treatment are limitations. High rates of retention in the treatment and adherence to the medication regimen are strengths. The concomitant psychotherapy may have caused a ceiling effect on medication.'}}, 'adverseEventsModule': {'timeFrame': '14 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.', 'otherNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.', 'otherNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cognitive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.30', 'spread': '.362', 'groupId': 'OG000'}, {'value': '-.20', 'spread': '.362', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.012', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).', 'unitOfMeasure': 'Days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Weekly Rate of Change in Abstinent Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '.02', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.94', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-04'}, {'type': 'SECONDARY', 'title': 'Change in Number of Drinks Per Week by Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).', 'unitOfMeasure': 'drinks/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was intention to treat and last observation carried forward', 'anticipatedPostingDate': '2010-04'}, {'type': 'SECONDARY', 'title': 'Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.', 'unitOfMeasure': 'units on a scale/visit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-05'}, {'type': 'SECONDARY', 'title': 'Change in Gamma-glutamyl Transferase (GGT) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '36.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 weeks (from initiation to end of treatment)', 'description': 'This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.', 'unitOfMeasure': 'Units/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonisamide Medication Treatment', 'description': 'Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of "dose" and number of pills matched that of the zonisamide arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '11', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-28', 'studyFirstSubmitDate': '2008-01-06', 'resultsFirstSubmitDate': '2010-05-15', 'studyFirstSubmitQcDate': '2008-01-06', 'lastUpdatePostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-28', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).'}, {'measure': 'Weekly Rate of Change in Abstinent Days', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Drinks Per Week by Week', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).'}, {'measure': 'Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)', 'timeFrame': 'baseline to the end of 12 weeks in treatment', 'description': 'This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.'}, {'measure': 'Change in Gamma-glutamyl Transferase (GGT) Concentration', 'timeFrame': '12 weeks (from initiation to end of treatment)', 'description': 'This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Zonisamide', 'Pharmacotherapy', 'Alcohol dependence', 'anticonvulsant'], 'conditions': ['Alcoholism', 'Alcohol Abuse', 'Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.', 'detailedDescription': 'Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism.\n\nThis is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 65 years, inclusive\n* current Diagnostic \\& Statistical Manual of Mental Disorders 4th ed (DSM-IV) alcohol dependence (within the past month)\n* have 2 heavy drinking days per week during the period between screening and baseline (defined as \\>4 standard drinks per day for males, and \\>3 standard drinks per day for females)\n* able to read at the eighth grade or higher level and show no evidence of significant cognitive impairment\n* if a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who is less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control including barrier method; and have a negative serum pregnancy test prior to initiation of treatment\n* be willing to provide signed, informed consent to participate in the study\n\nExclusion Criteria:\n\n* have a current, clinically significant physical disease or abnormality (i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities such as hepatic aminotransferase levels greater than 300% of the uper limit of normal or direct bilirubin levels 150% of the upper limit of normal) on the basis of medical history, physician examination, or routine laboratory evaluation. Serum creatinine level of \\> 1.2 mg/dl will also be exclusionary. Other specific exclusionary disorders include:\n\n * patients with a history of renal calculi\n * patients with a history of hypersensitivity to zonisamide or any sulfonamide, Stevens-Johnson Syndrome, penicillin allergy, or history of any severe drug allergic reaction\n * patients with a significant history of systemic autoimmune disease such as lupus erythematosis, fibromyalgia, or rheumatoid arthritis\n * patients with a current blood dyscrasia or a history of such, with the exception of a remote history of iron deficient anemia\n* have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, or substantial suicide or violence risk) on the basis of history or psychiatric examination\n* current dependence on opioids or benzodiazepines or other sedatives will also be exclusionary\n* are considered by investigators to be clinically inappropriate for study participation\n* because individuals with a history of seizure disorder could potentially be at increased risk of experiencing a seizure due to their drinking, such individuals will also be excluded\n* have participated in another pharmacotherapy study in the past thirty days'}, 'identificationModule': {'nctId': 'NCT00595556', 'briefTitle': 'Zonisamide vs. Placebo in the Treatment of Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Zonisamide vs. Placebo in the Treatment of Alcohol Dependence', 'orgStudyIdInfo': {'id': '06-113-1'}, 'secondaryIdInfos': [{'id': 'P50AA003510', 'link': 'https://reporter.nih.gov/quickSearch/P50AA003510', 'type': 'NIH'}, {'id': 'M01RR006192', 'link': 'https://reporter.nih.gov/quickSearch/M01RR006192', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Zonisamide', 'interventionNames': ['Drug: zonisamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'zonisamide', 'type': 'DRUG', 'otherNames': ['Zonegran'], 'description': 'flexible dosages of 100-500mg/day', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Albert J. Arias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Albert J. Arias, MD', 'oldOrganization': 'University of Connecticut Health Center'}}}}