Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-24 @ 9:47 PM
Study NCT ID:
NCT02949934
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control
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': 'D000077867', 'term': 'Tolcapone'}], 'ancestors': [{'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009596', 'term': 'Nitrophenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009574', 'term': 'Nitro Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph.schacht@cuanschutz.edu', 'phone': '(303) 724-3773', 'title': 'Joseph P. Schacht, Ph.D.', 'organization': 'University of Colorado School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Standard Drinks Per Day Consumed During Natural (Usual Environment) Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'OG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype'}], 'classes': [{'categories': [{'measurements': [{'value': '6.018', 'spread': '0.586', 'groupId': 'OG000'}, {'value': '3.534', 'spread': '0.668', 'groupId': 'OG001'}, {'value': '3.998', 'spread': '0.538', 'groupId': 'OG002'}, {'value': '5.012', 'spread': '0.567', 'groupId': 'OG003'}, {'value': '5.271', 'spread': '0.596', 'groupId': 'OG004'}, {'value': '5.949', 'spread': '0.602', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'groupDescription': 'Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.'}], 'paramType': 'MEAN', 'timeFrame': 'Days 1-6 of study medication ingestion', 'description': 'Number of standard alcoholic drinks per day that participants reported consuming, as assessed by the Timeline Follow-back method.', 'unitOfMeasure': 'standard drinks per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Number of Drinks Under Controlled Conditions (Bar Lab)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'OG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype'}], 'classes': [{'categories': [{'measurements': [{'value': '5.353', 'spread': '0.721', 'groupId': 'OG000'}, {'value': '3.256', 'spread': '0.955', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '0.812', 'groupId': 'OG002'}, {'value': '4.964', 'spread': '0.752', 'groupId': 'OG003'}, {'value': '1.68', 'spread': '0.935', 'groupId': 'OG004'}, {'value': '4.732', 'spread': '0.704', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'groupDescription': 'Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates were age, baseline AUDIT score, and baseline drinks per day.'}], 'paramType': 'MEAN', 'timeFrame': '2 hours during the alcohol challenge procedure', 'description': 'Total number of drinks, out of 8 possible, that participants chose to consume in the bar laboratory after receipt of a priming drink, targeted by sex and body weight to produce a breath alcohol concentration of 0.03 g/dL. Each of the drinks that participants chose to consume was targeted to produce a breath alcohol concentration of 0.015 g/dL. Participants were given a "bar credit" of $16 with which to "purchase" drinks, at the cost of $2/drink, and were told that any money they did not spend would be given to them the following day.', 'unitOfMeasure': 'Drinks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID-19 pandemic and the need for social distancing, a protocol amendment was required to remove the bar lab procedure. Thus, this outcome was assessed for only the first 63 participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive-control-associated Brain Activation (fMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype\n\nPlacebo'}, {'id': 'OG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype\n\nTolcapone'}, {'id': 'OG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype\n\nPlacebo'}, {'id': 'OG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype\n\nTolcapone'}, {'id': 'OG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype\n\nPlacebo'}, {'id': 'OG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype\n\nTolcapone'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.196', 'spread': '.086', 'groupId': 'OG000'}, {'value': '-0.063', 'spread': '.082', 'groupId': 'OG001'}, {'value': '-0.178', 'spread': '.074', 'groupId': 'OG002'}, {'value': '0.076', 'spread': '.076', 'groupId': 'OG003'}, {'value': '-0.017', 'spread': '.082', 'groupId': 'OG004'}, {'value': '-0.224', 'spread': '.086', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner'}], 'paramType': 'MEAN', 'timeFrame': '7 days--change between baseline and scan on day 7', 'description': 'Magnitude of change between baseline and day 7 scan in the BOLD signal in the right inferior frontal gyrus to spatial working memory', 'unitOfMeasure': 'Arbitrary units (Day 7 minus Baseline)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both fMRI scans and had usable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Alcohol Cue-elicited Brain Activation (fMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'OG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'OG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'OG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '.070', 'groupId': 'OG000'}, {'value': '-0.045', 'spread': '.070', 'groupId': 'OG001'}, {'value': '0.066', 'spread': '.063', 'groupId': 'OG002'}, {'value': '-0.164', 'spread': '.063', 'groupId': 'OG003'}, {'value': '0.138', 'spread': '.070', 'groupId': 'OG004'}, {'value': '.006', 'spread': '.070', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model testing interaction between medication group and time, controlling for scanner'}], 'paramType': 'MEAN', 'timeFrame': '7 days--change between baseline and scan on day 7', 'description': 'Magnitude of change between baseline and day 7 scan in the right inferior frontal gyrus blood oxygenation level dependent (BOLD) signal to alcohol cues, relative to neutral beverage cues (alcohol cue reactivity task described in Schacht et al., 2013, Neuropsychopharmacology)', 'unitOfMeasure': 'Arbitrary units (Day 7 minus Baseline)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both fMRI scans and had usable scan data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'FG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'FG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'FG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'FG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'FG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype'}], 'periods': [{'title': 'Natural Drinking Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Neuroimaging', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Motion artifacts in imaging data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Not scanned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}, {'title': 'Bar Laboratory', 'milestones': [{'type': 'STARTED', 'comment': 'The number of participants who started the bar laboratory on Day 8 is in some cases greater than the number who completed neuroimaging on Day 7. Some participants were not scanned on Day 7 and some had unusable neuroimaging data due to motion, but still started the bar laboratory.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Procedure not done due to COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were genotyped for the COMT rs4680 single nucleotide polymorphism and subsequently randomized, on the basis of their rs4680 genotype, to take tolcapone or placebo for eight days. Outcomes were the number of standard alcoholic drinks consumed during Days 1-6 ("Natural Drinking Period"), alcohol cue-elicited brain activation on Day 7 ("Neuroimaging"), and the number of drinks, out of 8 possible, that participants chose to self-administer in the lab on Day 8 ("Bar Laboratory").'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/rs4680 Val/Val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'BG001', 'title': 'Tolcapone/rs4680 Val/Val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype'}, {'id': 'BG002', 'title': 'Placebo/rs4680 Val/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'BG003', 'title': 'Tolcapone/rs4680 Val/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype'}, {'id': 'BG004', 'title': 'Placebo/rs4680 Met/Met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'BG005', 'title': 'Tolcapone/rs4680 Met/Met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '25.7', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '26.3', 'spread': '5.0', 'groupId': 'BG003'}, {'value': '26.3', 'spread': '5.2', 'groupId': 'BG004'}, {'value': '25.3', 'spread': '5.7', 'groupId': 'BG005'}, {'value': '26.5', 'spread': '5.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Non-treatment-seeking individuals between the ages of 21 and 40 with DSM-5 diagnosed Alcohol Use Disorder.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-11', 'size': 633703, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-17T18:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2016-10-26', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-21', 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitive-control-associated Brain Activation (fMRI)', 'timeFrame': '7 days--change between baseline and scan on day 7', 'description': 'Magnitude of change between baseline and day 7 scan in the BOLD signal in the right inferior frontal gyrus to spatial working memory'}, {'measure': 'Alcohol Cue-elicited Brain Activation (fMRI)', 'timeFrame': '7 days--change between baseline and scan on day 7', 'description': 'Magnitude of change between baseline and day 7 scan in the right inferior frontal gyrus blood oxygenation level dependent (BOLD) signal to alcohol cues, relative to neutral beverage cues (alcohol cue reactivity task described in Schacht et al., 2013, Neuropsychopharmacology)'}], 'primaryOutcomes': [{'measure': 'Total Number of Standard Drinks Per Day Consumed During Natural (Usual Environment) Conditions', 'timeFrame': 'Days 1-6 of study medication ingestion', 'description': 'Number of standard alcoholic drinks per day that participants reported consuming, as assessed by the Timeline Follow-back method.'}, {'measure': 'Total Number of Drinks Under Controlled Conditions (Bar Lab)', 'timeFrame': '2 hours during the alcohol challenge procedure', 'description': 'Total number of drinks, out of 8 possible, that participants chose to consume in the bar laboratory after receipt of a priming drink, targeted by sex and body weight to produce a breath alcohol concentration of 0.03 g/dL. Each of the drinks that participants chose to consume was targeted to produce a breath alcohol concentration of 0.015 g/dL. Participants were given a "bar credit" of $16 with which to "purchase" drinks, at the cost of $2/drink, and were told that any money they did not spend would be given to them the following day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '35523943', 'type': 'DERIVED', 'citation': 'Schacht JP, Yeongbin Im, Hoffman M, Voronin KE, Book SW, Anton RF. Effects of pharmacological and genetic regulation of COMT activity in alcohol use disorder: a randomized, placebo-controlled trial of tolcapone. Neuropsychopharmacology. 2022 Oct;47(11):1953-1960. doi: 10.1038/s41386-022-01335-z. Epub 2022 May 6.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the catechol-O-methyltransferase (COMT) inhibitor tolcapone, relative to placebo, reduces alcohol drinking and alcohol cue-elicited brain activation and increases brain activation associated with cognitive control as a function of a participant's genotype at a polymorphism in the COMT gene."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 21-40 (to focus on an age group still on a trajectory of increasing alcohol consumption).\n2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder.\n3. Currently not engaged in, and does not want treatment for, alcohol-related problems.\n4. Able to read and understand questionnaires and informed consent.\n5. Lives within 50 miles of the study site.\n6. Able to maintain abstinence from alcohol for two days (without the aid of detoxification medications), as determined by self report and breathalyzer measurements.\n\nExclusion Criteria:\n\n1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.\n2. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days, as indicated by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine tetrahydrocannibinol (THC) levels.\n3. Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.\n4. Current suicidal ideation or homicidal ideation.\n5. Need for maintenance or acute treatment with any psychoactive medication, including antiepileptic medications.\n6. Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).\n7. History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).\n8. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.\n9. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.\n10. Current or past hepatocellular disease, as indicated by verbal report or elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of the normal range at screening.\n11. Females of childbearing potential who are pregnant (by urine human chorionic gonadotropin), nursing, or who are not using a reliable form of birth control.\n12. Current charges pending for a violent crime (not including drinking while intoxicated).\n13. Lack of a stable living situation.\n14. Presence of ferrous metal in the body, as evidenced by metal screening and self-report.\n15. Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.\n16. History of head injury with \\> 2 minutes of unconsciousness.'}, 'identificationModule': {'nctId': 'NCT02949934', 'briefTitle': 'Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'orgStudyIdInfo': {'id': 'Pro00050157'}, 'secondaryIdInfos': [{'id': 'P50AA010761', 'link': 'https://reporter.nih.gov/quickSearch/P50AA010761', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/rs4680 val/val', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/val genotype', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tolcapone/rs4680 val/val', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/val genotype', 'interventionNames': ['Drug: Tolcapone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/rs4680 val/met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 val/met genotype', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tolcapone/rs4680 val/met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 val/met genotype', 'interventionNames': ['Drug: Tolcapone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/rs4680 met/met', 'description': 'Placebo three times per day for eight days\n\nIndividuals with the rs4680 met/met genotype', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tolcapone/rs4680 met/met', 'description': 'Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days\n\nIndividuals with the rs4680 met/met genotype', 'interventionNames': ['Drug: Tolcapone']}], 'interventions': [{'name': 'Tolcapone', 'type': 'DRUG', 'otherNames': ['Tasmar'], 'armGroupLabels': ['Tolcapone/rs4680 met/met', 'Tolcapone/rs4680 val/met', 'Tolcapone/rs4680 val/val']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo/rs4680 met/met', 'Placebo/rs4680 val/met', 'Placebo/rs4680 val/val']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished University Professor', 'investigatorFullName': 'Raymond F. Anton', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}