Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}}}}, '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': 'D015248', 'term': 'Gemfibrozil'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eclaus@mrn.org', 'phone': '5055151556', 'title': 'Dr. Eric Claus', 'organization': 'The Mind Research Network'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Standard Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '6.17', 'groupId': 'OG000', 'lowerLimit': '5.57', 'upperLimit': '6.76'}, {'value': '8.59', 'groupId': 'OG001', 'lowerLimit': '8.59', 'upperLimit': '8.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Average number of standard drinks consumed on drinking days', 'unitOfMeasure': 'Drinks per drinking day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Standard Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '4.667'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post baseline', 'description': 'Average number of standard drinks consumed on drinking days', 'unitOfMeasure': 'Drinks per drinking day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant in the placebo condition dropped out before taking any medication'}, {'type': 'PRIMARY', 'title': 'Mean Standard Drinks Per Drinking Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.35'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post baseline', 'description': 'Average number of standard drinks consumed on drinking days', 'unitOfMeasure': 'Drinks per drinking day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant in the placebo condition dropped out before taking any medication'}, {'type': 'PRIMARY', 'title': 'Percent Days Abstinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '44.4'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '32.2', 'upperLimit': '32.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Percentage of days of abstinence from alcohol', 'unitOfMeasure': 'Percentage of abstinent days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Days Abstinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post baseline', 'description': 'Percentage of days of abstinence from alcohol', 'unitOfMeasure': 'Percentage of abstinent days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant in the placebo condition dropped out before taking any medication'}, {'type': 'PRIMARY', 'title': 'Percent Days Abstinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks post baseline', 'description': 'Percentage of days of abstinence from alcohol', 'unitOfMeasure': 'Percentage of abstinent days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant in the placebo condition dropped out before taking any medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily\n\nGemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition\n\nPlacebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication'}, {'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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 394392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-21T16:35', 'hasProtocol': True}, {'date': '2018-06-29', 'size': 363886, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-21T16:39', 'hasProtocol': False}]}}, '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': 3}}, 'statusModule': {'whyStopped': 'Funds for the study expired', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2018-05-16', 'resultsFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-21', 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Standard Drinks Per Drinking Day', 'timeFrame': 'Baseline', 'description': 'Average number of standard drinks consumed on drinking days'}, {'measure': 'Mean Standard Drinks Per Drinking Day', 'timeFrame': '2 weeks post baseline', 'description': 'Average number of standard drinks consumed on drinking days'}, {'measure': 'Mean Standard Drinks Per Drinking Day', 'timeFrame': '4 weeks post baseline', 'description': 'Average number of standard drinks consumed on drinking days'}, {'measure': 'Percent Days Abstinent', 'timeFrame': 'Baseline', 'description': 'Percentage of days of abstinence from alcohol'}, {'measure': 'Percent Days Abstinent', 'timeFrame': '2 weeks post baseline', 'description': 'Percentage of days of abstinence from alcohol'}, {'measure': 'Percent Days Abstinent', 'timeFrame': '4 weeks post baseline', 'description': 'Percentage of days of abstinence from alcohol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year\n2. interested in cutting down or quitting drinking\n3. able to provide voluntary informed consent\n4. have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days\n\nExclusion Criteria:\n\n1. severe liver disease; severe kidney disease; gallbladder disease or gallstones\n2. chronic renal or hepatic failure\n3. recent pancreatitis\n4. insulin-dependent diabetes\n5. other urgent medical problems\n6. moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)\n7. schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month\n8. current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)\n9. active legal problems with the potential to result in incarceration\n10. pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)\n11. current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics\n12. regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68\n13. a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years\n14. a history of moderate or severe traumatic brain injury (TBI; loss of consciousness \\>30 minutes69)\n15. left-handedness\n16. any contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT03539432', 'briefTitle': 'Exploration of Gemfibrozil as a Treatment for AUD', 'organization': {'class': 'OTHER', 'fullName': 'The Mind Research Network'}, 'officialTitle': 'Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '20-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemfibrozil', 'description': 'Gemfibrozil 600 mg by mouth twice daily', 'interventionNames': ['Drug: Gemfibrozil 600 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental condition', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Gemfibrozil 600 MG', 'type': 'DRUG', 'description': 'Gemfibrozil capsules (600 mg) taken twice per day', 'armGroupLabels': ['Gemfibrozil']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Microcrystalline cellulose powder packaged in capsules identical to the experimental medication', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'The Mind Research Network', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Mind Research Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}