Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00256451
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Endophenotype for Alcohol Misuse in Healthy Minority Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oslin@upenn.edu', 'phone': '2158235894', 'title': 'David Oslin, MD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored during each session which typically occurred over 3 hours.', 'description': 'We assessed for any adverse event reported related to the medication taken prior to the session or the alcohol during the session.', 'eventGroups': [{'id': 'EG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biphasic Alcohol Effects Scale - Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol'}, {'id': 'OG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '7.6', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '4.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During challenge sessions', 'description': 'Change from baseline to peak for the feeling of stimulation after alcohol ingestion\n\nBiphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Profile of Mood States - Vigor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol'}, {'id': 'OG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the challenge session', 'description': 'Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion\n\nProfile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective High From Alcohol Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol'}, {'id': 'OG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the alcohol ingestion', 'description': 'Change from baseline to peak for the self reported feeling of being high after drinking\n\nSubjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale - Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol'}, {'id': 'OG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '15.8', 'groupId': 'OG002'}, {'value': '15.4', 'spread': '16.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the challenge session', 'description': 'Change from baseline to peak of the amount of sedation post ingestion of alcohol\n\nBiphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Profile of Mood States - Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ALC and NAL', 'description': 'alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG001', 'title': 'Placebo ALC and NAL', 'description': '"sham" alcohol and active naltrexone\n\nNaltrexone: 50 mg/day for two days prior to the alcohol challenge session\n\nSham alcohol: non-alcoholic placebo alcohol'}, {'id': 'OG002', 'title': 'Placebo Pill and ALC', 'description': 'placebo naltrexone and alcohol\n\nplacebo: placebo pills\n\nalcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'OG003', 'title': 'Placebo Pill and Placebo ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol\n\nplacebo: placebo pills\n\nSham alcohol: non-alcoholic placebo alcohol'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the challenge session', 'description': 'Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion\n\nProfile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ntx-Alc; Placebo-Sham; Ntx-Sham; Placebo-Alc', 'description': 'Session1: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession2:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session3: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session4: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'FG001', 'title': 'Ntx-Sham; Ntx-Alc; Placebo-Alc; Placebo-Sham', 'description': 'Session1: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session2: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession3: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession4: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol'}, {'id': 'FG002', 'title': 'Placebo-Alc; Ntx-Sham; Placebo-Sham; Ntx-Alc', 'description': 'Session1: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession2: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session3:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session4: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.'}, {'id': 'FG003', 'title': 'Placebo-Sham; Placebo-Alc; Ntx-Alc; Ntx-Sham', 'description': 'Session1: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session2: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession3: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.\n\nSession4: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol'}], 'periods': [{'title': 'Session1', 'milestones': [{'type': 'STARTED', 'comment': 'Crossover design: no of subjs who completed the PRIOR session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Session2', 'milestones': [{'type': 'STARTED', 'comment': 'Crossover design: no of subjs who completed the PRIOR session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Session3', 'milestones': [{'type': 'STARTED', 'comment': 'Crossover design: no of subjs who completed the PRIOR session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Session4', 'milestones': [{'type': 'STARTED', 'comment': 'Crossover design: no of subjs who completed the PRIOR session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were only randomized to 4 sequences and not to all 12 possible sequences.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'all participants in the cross over study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol use', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The average number of standard drinks per week prior to the trial.', 'unitOfMeasure': 'total number of drinks in the week prior', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2005-11-17', 'resultsFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2005-11-17', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-16', 'studyFirstPostDateStruct': {'date': '2005-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biphasic Alcohol Effects Scale - Stimulation', 'timeFrame': 'During challenge sessions', 'description': 'Change from baseline to peak for the feeling of stimulation after alcohol ingestion\n\nBiphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.'}, {'measure': 'Profile of Mood States - Vigor', 'timeFrame': 'during the challenge session', 'description': 'Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion\n\nProfile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome'}, {'measure': 'Subjective High From Alcohol Scale', 'timeFrame': 'during the alcohol ingestion', 'description': 'Change from baseline to peak for the self reported feeling of being high after drinking\n\nSubjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes'}], 'secondaryOutcomes': [{'measure': 'Biphasic Alcohol Effects Scale - Sedation', 'timeFrame': 'During the challenge session', 'description': 'Change from baseline to peak of the amount of sedation post ingestion of alcohol\n\nBiphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes'}, {'measure': 'Profile of Mood States - Fatigue Scale', 'timeFrame': 'During the challenge session', 'description': 'Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion\n\nProfile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Naltrexone', 'Alcohol'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.', 'detailedDescription': 'We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female and 21 years of age or older\n* Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per week\n* Of African descent by self report\n\nExclusion Criteria:\n\n* Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine\n* Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana, or amphetamine at the screening visit\n* Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder\n* The presence of unstable or serious medical illness; including history of stroke, seizure disorder, severe liver disease (AST or ALT \\> 5X normal at the time of randomization), or unstable cardiac disease\n* Needs treatment with any psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication)\n* Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable method of contraception\n* Insulin-dependent diabetes\n* Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI."}, 'identificationModule': {'nctId': 'NCT00256451', 'acronym': 'DEFINE', 'briefTitle': 'Endophenotype for Alcohol Misuse in Healthy Minority Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Defining an Endophenotype for Alcohol Misuse: A Focus On Minority Populations', 'orgStudyIdInfo': {'id': '803866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALC and NAL', 'description': 'alcohol and active naltrexone', 'interventionNames': ['Drug: Naltrexone', 'Other: alcohol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham ALC and NAL', 'description': '"sham" alcohol and active naltrexone', 'interventionNames': ['Drug: Naltrexone', 'Other: Sham alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo pill and ALC', 'description': 'placebo naltrexone and alcohol', 'interventionNames': ['Drug: placebo', 'Other: alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo pill and Sham ALC', 'description': 'placebo naltrexone and placebo (non-alcoholic) alcohol', 'interventionNames': ['Drug: placebo', 'Other: Sham alcohol']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'otherNames': ['ReVia'], 'description': '50 mg/day for two days prior to the alcohol challenge session', 'armGroupLabels': ['ALC and NAL', 'Sham ALC and NAL']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo pills', 'armGroupLabels': ['placebo pill and ALC', 'placebo pill and Sham ALC']}, {'name': 'alcohol', 'type': 'OTHER', 'description': '190 proof alcohol prepared to 11% volume mixed with fruit juice.', 'armGroupLabels': ['ALC and NAL', 'placebo pill and ALC']}, {'name': 'Sham alcohol', 'type': 'OTHER', 'description': 'non-alcoholic placebo alcohol', 'armGroupLabels': ['Sham ALC and NAL', 'placebo pill and Sham ALC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Treatment Research Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Oslin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Oslin', 'investigatorAffiliation': 'University of Pennsylvania'}}}}