Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01211769
Status:
COMPLETED
Last Update Posted:
2010-09-29
First Post:
2008-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Omegas 3 and 6 on 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': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'galduroz@psicobio.epm.br', 'phone': '55 11 21490168', 'title': 'José Carlos Fernandes Galduróz', 'organization': 'UNIFESP'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '"Drinking Days" in the Previous Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;'}, {'id': 'OG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg'}], 'classes': [{'title': 'Number of "Drinking Days" Baseline', 'categories': [{'measurements': [{'value': '19.54', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '15.18', 'spread': '10.32', 'groupId': 'OG001'}, {'value': '17.75', 'spread': '9.80', 'groupId': 'OG002'}, {'value': '22.11', 'spread': '11.63', 'groupId': 'OG003'}]}]}, {'title': 'Number of "Drinking Days" Final', 'categories': [{'measurements': [{'value': '4.72', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '7.48', 'groupId': 'OG001'}, {'value': '11.08', 'spread': '12.87', 'groupId': 'OG002'}, {'value': '11.12', 'spread': '13.74', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': 'TIME COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.69', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Variance (F)', 'ciPctValue': '95', 'paramValue': '0.71', 'groupDescription': 'GROUP COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2008-10'}, {'type': 'SECONDARY', 'title': 'Short Alcohol Dependence Data Questionnaire (SADD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;'}, {'id': 'OG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg'}], 'classes': [{'title': 'SADD Baseline', 'categories': [{'measurements': [{'value': '34.90', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '33.81', 'spread': '9.92', 'groupId': 'OG001'}, {'value': '31.91', 'spread': '10.99', 'groupId': 'OG002'}, {'value': '29.33', 'spread': '11.11', 'groupId': 'OG003'}]}]}, {'title': 'SADD Final', 'categories': [{'measurements': [{'value': '7.81', 'spread': '11.93', 'groupId': 'OG000'}, {'value': '11.36', 'spread': '14.29', 'groupId': 'OG001'}, {'value': '7.81', 'spread': '11.93', 'groupId': 'OG002'}, {'value': '9.16', 'spread': '11.16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': 'TIME COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.53', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Variance (F)', 'ciPctValue': '95', 'paramValue': '0.73', 'groupDescription': 'GROUP COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2008-10'}, {'type': 'SECONDARY', 'title': 'Obsessive Compulsive Drinking Scale (OCDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'OG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;'}, {'id': 'OG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg'}], 'classes': [{'title': 'OCDS Baseline', 'categories': [{'measurements': [{'value': '45.36', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '42.45', 'spread': '12.56', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '14.88', 'groupId': 'OG002'}, {'value': '37.55', 'spread': '10.47', 'groupId': 'OG003'}]}]}, {'title': 'OCDS Final', 'categories': [{'measurements': [{'value': '13.18', 'spread': '14.98', 'groupId': 'OG000'}, {'value': '11.81', 'spread': '15.09', 'groupId': 'OG001'}, {'value': '19.16', 'spread': '20.93', 'groupId': 'OG002'}, {'value': '14.00', 'spread': '13.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': 'TIME COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Variance (F)', 'ciPctValue': '95', 'paramValue': '1.08', 'groupDescription': 'GROUP COMPARISON', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2008-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'FG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'FG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;'}, {'id': 'FG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Participants/Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'We comprised the sample through advertisement in newspaper and referral from outpatient services specialized in alcohol dependence treatment. The requirement for their participation was that they were not following any other treatment during the study.', 'preAssignmentDetails': '645 individuals contacted; 325 were excluded after answering the questionnaire by phone. Most of the remaining 320 patients did not meet the inclusion criteria.\n\n80 patients participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'BG001', 'title': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.'}, {'id': 'BG002', 'title': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;'}, {'id': 'BG003', 'title': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '00', 'groupId': 'BG000'}, {'value': '00', 'groupId': 'BG001'}, {'value': '00', 'groupId': 'BG002'}, {'value': '00', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '00', 'groupId': 'BG000'}, {'value': '00', 'groupId': 'BG001'}, {'value': '00', 'groupId': 'BG002'}, {'value': '00', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '3.94', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '6.44', 'groupId': 'BG001'}, {'value': '40.66', 'spread': '6.74', 'groupId': 'BG002'}, {'value': '43.33', 'spread': '4.84', 'groupId': 'BG003'}, {'value': '42.67', 'spread': '5.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-02', 'studyFirstSubmitDate': '2008-12-05', 'resultsFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-02', 'studyFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Drinking Days" in the Previous Month', 'timeFrame': '3 months', 'description': 'The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.'}], 'secondaryOutcomes': [{'measure': 'Short Alcohol Dependence Data Questionnaire (SADD)', 'timeFrame': '3 months', 'description': 'The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.'}, {'measure': 'Obsessive Compulsive Drinking Scale (OCDS)', 'timeFrame': '3 months', 'description': 'The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PUFAs', 'Alcoholism', 'Treatment', 'Effectiveness'], 'conditions': ['Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '21787433', 'type': 'DERIVED', 'citation': 'Fogaca MN, Santos-Galduroz RF, Eserian JK, Galduroz JC. The effects of polyunsaturated fatty acids in alcohol dependence treatment--a double-blind, placebo-controlled pilot study. BMC Clin Pharmacol. 2011 Jul 26;11:10. doi: 10.1186/1472-6904-11-10.'}]}, 'descriptionModule': {'briefSummary': "Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.\n\nObjective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe alcohol dependence\n* no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range\n\nExclusion Criteria:\n\n* history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies\n* dependences other than alcohol and/or tobacco\n* psychiatric disorders\n* test laboratories results outside the reference range'}, 'identificationModule': {'nctId': 'NCT01211769', 'briefTitle': 'Effects of Omegas 3 and 6 on Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Alcohol Dependence: Study of the Possible Reduction of Compulsion by Association of Naltrexone With Poly-unsaturated Fatty Acids (PUFAs)', 'orgStudyIdInfo': {'id': '2006/01641-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;', 'interventionNames': ['Drug: PUFAs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naltrexone', 'description': 'Naltrexone chlorhydrate 50 mg', 'interventionNames': ['Drug: Naltrexone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;\n\nPolyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Naltrexone + PUFAs', 'description': 'Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;\n\nNaltrexone chlorhydrate 50 mg', 'interventionNames': ['Drug: Naltrexone + Placebo']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'description': 'A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.', 'armGroupLabels': ['Naltrexone']}, {'name': 'PUFAs', 'type': 'DRUG', 'description': 'Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.', 'armGroupLabels': ['PUFAs']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).', 'armGroupLabels': ['Placebo']}, {'name': 'Naltrexone + Placebo', 'type': 'DRUG', 'description': 'A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.', 'armGroupLabels': ['Naltrexone + PUFAs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'José Carlos F Galduróz, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Associacao Fundo de Incentivo a Psicofarmcologia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'José Carlos Fernandes Galduróz', 'oldOrganization': 'Adjuncto Professor of UNIFESP'}}}}