Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-30 @ 2:53 PM
Study NCT ID:
NCT00466661
Status:
COMPLETED
Last Update Posted:
2018-12-14
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acamprosate vs. Placebo in Bipolar Alcoholics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077443', 'term': 'Acamprosate'}], 'ancestors': [{'id': 'D013654', 'term': 'Taurine'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tollive@musc.edu', 'phone': '(843) 792-4869', 'title': 'Bryan K. Tolliver, M.D., Ph.D. (Principal Investigator)', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited sample size'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).', 'eventGroups': [{'id': 'EG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diffuse aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactoid skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Drink (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'comment': 'The upper range of the confidence interval was calculated to be infinity', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'The upper range of the confidence interval was calculated to be infinity', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Number of days after randomization until consumption of first alcoholic beverage per self-report.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Percent Days Abstinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '77.0', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Percentage of days in trial with no alcohol consumption', 'unitOfMeasure': 'percentage of days in trial', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Percent Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)', 'unitOfMeasure': 'percentage of days drinking', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Percent Carbohydrate-deficient Transferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Measured level of validated serum alcohol biomarker', 'unitOfMeasure': '"percent CDT"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Gamma-glutamyltransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '67.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Measured levels of validated serum alcohol biomarker', 'unitOfMeasure': 'Gamma-glutamyltransferase U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Obsessive Compulsive Drinking Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Higher scores indicate worse outcome; minimum score = 0, maximum score = 40', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Montgomery Asberg Depression Rating Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Young Mania Rating Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': 'Participants assigned to acamprosate with at least one return visit after randomization'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants assigned to placebo who returned for at least one visit after randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Higher values indicate worse outcomes; minimum value = 1, maximum value = 7', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acamprosate', 'description': '666 mg p.o. TID'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'At Least 1 Postrandomization Visit', 'comment': 'Defines modified Intention to Treat (mITT) sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Recruitment by clinical referral', 'preAssignmentDetails': 'Two week lead-in (Screening, Baseline)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acamprosate', 'description': '666 mg p.o. TID'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2007-04-25', 'resultsFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2007-04-26', 'lastUpdatePostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-12', 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Drink (Days)', 'timeFrame': '8 weeks', 'description': 'Number of days after randomization until consumption of first alcoholic beverage per self-report.'}], 'secondaryOutcomes': [{'measure': 'Percent Days Abstinent', 'timeFrame': '8 weeks', 'description': 'Percentage of days in trial with no alcohol consumption'}, {'measure': 'Percent Heavy Drinking Days', 'timeFrame': '8 weeks', 'description': 'Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)'}, {'measure': 'Percent Carbohydrate-deficient Transferrin', 'timeFrame': '8 weeks', 'description': 'Measured level of validated serum alcohol biomarker'}, {'measure': 'Gamma-glutamyltransferase', 'timeFrame': '8 weeks', 'description': 'Measured levels of validated serum alcohol biomarker'}, {'measure': 'Obsessive Compulsive Drinking Scale Score', 'timeFrame': '8 weeks', 'description': 'Higher scores indicate worse outcome; minimum score = 0, maximum score = 40'}, {'measure': 'Montgomery Asberg Depression Rating Scale Score', 'timeFrame': '8 weeks', 'description': 'MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.'}, {'measure': 'Young Mania Rating Scale Score', 'timeFrame': '8 weeks', 'description': 'YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.'}, {'measure': 'Clinical Global Impression Scale Score', 'timeFrame': '8 weeks', 'description': 'Higher values indicate worse outcomes; minimum value = 1, maximum value = 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acamprosate', 'Alcoholism', 'Bipolar disorder', 'Comorbidity', 'Craving', 'Depression', 'GABA', 'Glutamate', 'Mania', 'Pharmacotherapy', 'Withdrawal'], 'conditions': ['Alcohol Dependence', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.\n\nThe primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults ages 18-65\n2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence\n3. Meet DSM-IV criteria for bipolar I or bipolar II disorder\n4. Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days\n5. Must be able to remain free from alcohol for at least 3 days prior to medication initiation\n6. Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments\n7. Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments\n\nExclusion Criteria:\n\n1. Individuals with a primary psychiatric disorder other than bipolar disorder\n2. Individuals with an uncontrolled neurologic condition that could confound the results of the study\n3. Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety\n4. Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.\n5. Concomitant use of other psychotropic medications not allowed per the protocol\n6. Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control\n7. Current suicidal or homicidal risk\n8. Baseline scores of \\> 35 on the Montgomery Asberg Depression Rating Scale and/or \\> 25 on the Young Mania Rating Scale"}, 'identificationModule': {'nctId': 'NCT00466661', 'briefTitle': 'Acamprosate vs. Placebo in Bipolar Alcoholics', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder', 'orgStudyIdInfo': {'id': 'HR#16928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acamprosate', 'description': '666 mg p.o. TID', 'interventionNames': ['Drug: Acamprosate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acamprosate', 'type': 'DRUG', 'description': '666 mg po TID', 'armGroupLabels': ['Acamprosate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 tabs po TID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Institute of Psychiatry, Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Bryan K Tolliver, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina'}, {'name': 'Kathleen T Brady, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}