Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 5:25 PM
Study NCT ID:
NCT04218357
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2020-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Probenecid as Medication for Alcohol Use Disorder (PROB)
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': 'D011339', 'term': 'Probenecid'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carolina_haass-koffler@brown.edu', 'phone': '4155191385', 'title': 'Carolina Haass-Koffler, PharmD, PhD', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored during two laboratory sessions, visits 2 and 3, at which time probenecid and placebo were administered.', 'description': 'We reported any of the following Adverse Events:\n\n1. All-Cause Mortality in both conditions (none to report)\n2. Serious Adverse Events: in both conditions (none to report)\n3. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events that exceed a frequency threshold (maximum threshold, 5%) within both conditions, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study (none to report)', 'eventGroups': [{'id': 'EG000', 'title': 'Matching Placebo', 'description': 'Placebo, one pill by mouth once, for one day\n\nMatching placebo: Placebo', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Probenecid', 'description': '2g probenecid, one pill by mouth once, for one day\n\nProbenecid: safety', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo, one pill by mouth once, for one day\n\nMatching placebo: Placebo'}, {'id': 'OG001', 'title': 'Probenecid', 'description': '2g probenecid, one pill by mouth once, for one day\n\nProbenecid: safety'}], 'classes': [{'title': 'Ascending alcohol BrAC', 'categories': [{'measurements': [{'value': '28.23', 'spread': '21.82', 'groupId': 'OG000'}, {'value': '25.26', 'spread': '20.66', 'groupId': 'OG001'}]}]}, {'title': 'Descending alcohol BrAC', 'categories': [{'measurements': [{'value': '20.57', 'spread': '18.95', 'groupId': 'OG000'}, {'value': '19.56', 'spread': '20.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).\n\nThe BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).\n\nThe scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \\& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo, one pill by mouth once, for one day\n\nMatching placebo: Placebo'}, {'id': 'OG001', 'title': 'Probenecid', 'description': '2g probenecid, one pill by mouth once, for one day\n\nProbenecid: safety'}], 'classes': [{'title': 'Ascending limb of BrAC', 'categories': [{'measurements': [{'value': '16.02', 'spread': '14.21', 'groupId': 'OG000'}, {'value': '16.79', 'spread': '15.17', 'groupId': 'OG001'}]}]}, {'title': 'Descending limb of BrAC', 'categories': [{'measurements': [{'value': '16.26', 'spread': '15.27', 'groupId': 'OG000'}, {'value': '16.50', 'spread': '15.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'The sedative effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).\n\nThe BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the sedation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).\n\nThe scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \\& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo, one pill by mouth once, for one day\n\nMatching placebo: Placebo'}, {'id': 'OG001', 'title': 'Probenecid', 'description': '2g probenecid, one pill by mouth once, for one day\n\nProbenecid: safety'}], 'classes': [{'title': 'Ascending limb of BrAC', 'categories': [{'measurements': [{'value': '23.09', 'spread': '13.23', 'groupId': 'OG000'}, {'value': '17.24', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Descending limb of BrAC', 'categories': [{'measurements': [{'value': '19.63', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '12.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.'}], 'paramType': 'MEAN', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'Alcohol craving is assessed using change in the alcohol urge questionnaire (AUQ).\n\nThe Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent\'s feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome).', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matching Placebo, Then Probenecid', 'description': 'Study Drug one pill by mouth once, for one day\n\nMatching placebo: Placebo'}, {'id': 'FG001', 'title': 'Probenecid, Then Matching Placebo', 'description': '2g probenecid, one pill by mouth once, for one day\n\nProbenecid'}], 'periods': [{'title': '1st Allocation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '2nd Allocation (Cross Over)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Sample', 'description': 'Placebo, then probenecid one pill by mouth once, for one day or Probenecid then placebo one pill by mouth once, for one day'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of alcohol use disorder (AUD) by SCID-5', 'classes': [{'categories': [{'title': 'no AUD', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Mild AUD', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Moderate AUD', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Severe AUD', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-30', 'size': 883708, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-22T16:36', 'hasProtocol': True}, {'date': '2019-10-15', 'size': 290953, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-28T09:10', 'hasProtocol': False}, {'date': '2022-02-02', 'size': 912211, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-22T15:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2020-01-01', 'resultsFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-06', 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stimulant Effects of Alcohol When Co-administered With Drug or Matching Placebo', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'The stimulant effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).\n\nThe BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the stimulation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).\n\nThe scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \\& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.'}], 'secondaryOutcomes': [{'measure': 'Sedative Effects of Alcohol When Co-administered With Drug or Matching Placebo', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'The sedative effect of alcohol is assessed using the Biphasic Alcohol Effects Scale (BAES).\n\nThe BAES is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of 14 items (score) that are rated on a 11-point scale. 7 of the 14 items comprise the sedation subscale. Individuals are instructed to rate the extent to which alcohol has produced these feelings at the present time from minimum=0 to maximum=10. The subscale of stimulation has a minimum score of 0 (not at all, best outcome) and a maximum score of 70 (high, worse outcome).\n\nThe scale was validated and published: Martin, C. S., Earleywine, M., Musty, R. E., Perrine, M. W. \\& Swift R. M. (1993). Development and Validation of the Biphasic Alcohol Effects Scale. Alcoholism: Clinical and Experimental Research, 17, 140-146.'}, {'measure': 'Alcohol Craving', 'timeFrame': 'Twice at each laboratory session, visits 2 and 3, during the ascending and descending phase of alcohol administration (BrAC).', 'description': 'Alcohol craving is assessed using change in the alcohol urge questionnaire (AUQ).\n\nThe Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent\'s feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Minimum score is 7, maximum score is 48. Higher scores reflect greater alcohol craving (worse outcome).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '31535696', 'type': 'RESULT', 'citation': 'Tunstall BJ, Lorrai I, McConnell SA, Gazo KL, Zallar LJ, de Guglielmo G, Hoang I, Haass-Koffler CL, Repunte-Canonigo V, Koob GF, Vendruscolo LF, Sanna PP. Probenecid Reduces Alcohol Drinking in Rodents. Is Pannexin1 a Novel Therapeutic Target for Alcohol Use Disorder? Alcohol Alcohol. 2019 Jan 9;54(5):497-502. doi: 10.1093/alcalc/agz054.'}, {'pmid': '39472130', 'type': 'RESULT', 'citation': 'Hornbacher R, Gully BJ, Brown ZE, Brown JC, Magill M, Cioe PA, Swift RM, Sanna PP, Haass-Koffler CL. Probenecid as a pharmacotherapy for alcohol use disorder: A randomized placebo-controlled alcohol interaction trial. Alcohol Clin Exp Res (Hoboken). 2024 Dec;48(12):2391-2403. doi: 10.1111/acer.15470. Epub 2024 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The design is a randomized, within-subject, crossover, double-blind, placebo-controlled human alcohol laboratory study with one oral dose of 2g probenecid or placebo administered in two laboratory sessions.', 'detailedDescription': 'There will be a total of four study visits. Visit 1 is the screening for eligibility (medical and physical examination). On Visits 2 and 3, participants will undergo an alcohol laboratory session with a one week washout period before administering the alternate therapy. The study will conclude at Visit 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 21-70 (inclusive) years; women \\>7 drinks/week; men \\>14 drinks/week;\n* meet any DSM-5 criteria score for AUD;\n* Breath alcohol Content (BrAC)=0.00 at each visit;\n* In good health as confirmed by medical history, physical examination and lab tests;\n* Willing to adhere to the study procedures;\n* Understand informed consent and questionnaires in English at an 8th grade level\n\nExclusion Criteria:\n\n* Women who are breastfeeding or have a positive urine screen for pregnancy\n* CrCl \\< 60mL/min\n* Taking aspirin (salicylates may reduce effect of probenecid)\n* Taking penicillin\n* Taking methotrexate (may increase concentration)\n* Taking other medications that may interact with probenecid\n* History of suicide attempts in the last three years\n* Current diagnosis of another substance disorder(s) other than nicotine, as assessed by self-reports and urine toxicology screen at baseline\n* History of hypersensitivity to sulfa drugs'}, 'identificationModule': {'nctId': 'NCT04218357', 'acronym': 'PROB', 'briefTitle': 'Probenecid as Medication for Alcohol Use Disorder (PROB)', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Probenecid as Pharmacotherapy for Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '1908002524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probenecid', 'description': '2g probenecid, one pill by mouth once, for one day', 'interventionNames': ['Drug: Probenecid or placebo single administration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo', 'description': 'Placebo, one pill by mouth once, for one day', 'interventionNames': ['Drug: Probenecid or placebo single administration']}], 'interventions': [{'name': 'Probenecid or placebo single administration', 'type': 'DRUG', 'otherNames': ['Probalan'], 'description': 'study drug administration with alcohol in the laboratory', 'armGroupLabels': ['Probenecid', 'matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20923', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Carolina L Haass-Koffler, PHARMD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carolina L Haass-Koffler', 'investigatorAffiliation': 'Brown University'}}}}