Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT03575403
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2018-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
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': 'D000431', 'term': 'Ethanol'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'crush2@uky.edu', 'phone': '8592575388', 'title': 'Dr. Craig R. Rush, Ph.D.', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Four weeks', 'description': 'Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in Urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of Voice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes in Sexual Function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness/Dowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stuffy/Runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual Bruising/Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Racing/Pounding Heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reinforcing Effects (Pre-Alcohol Dose Consumption)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine 30 mg', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0043', 'upperLimit': '0.0057'}, {'value': '.01', 'groupId': 'OG001', 'lowerLimit': '0.0078', 'upperLimit': '0.012'}, {'value': '0.007', 'groupId': 'OG002', 'lowerLimit': '0.005', 'upperLimit': '0.008'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0041', 'upperLimit': '0.0058'}, {'value': '.02', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.020'}, {'value': '0.007', 'groupId': 'OG002', 'lowerLimit': '0.006', 'upperLimit': '0.009'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0041', 'upperLimit': '0.0057'}, {'value': '0.014', 'groupId': 'OG001', 'lowerLimit': '0.012', 'upperLimit': '0.018'}, {'value': '0.007', 'groupId': 'OG002', 'lowerLimit': '0.006', 'upperLimit': '0.008'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0041', 'upperLimit': '0.0057'}, {'value': '.02', 'groupId': 'OG001', 'lowerLimit': '0.012', 'upperLimit': '0.020'}, {'value': '0.008', 'groupId': 'OG002', 'lowerLimit': '0.006', 'upperLimit': '0.009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.', 'unitOfMeasure': 'Units on a Theoretical Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Reinforcing Effects (Post-Alcohol Dose Consumption)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '0.004', 'groupId': 'OG000', 'lowerLimit': '0.0038', 'upperLimit': '0.0052'}, {'value': '.01', 'groupId': 'OG001', 'lowerLimit': '0.0075', 'upperLimit': '0.010'}, {'value': '0.006', 'groupId': 'OG002', 'lowerLimit': '0.005', 'upperLimit': '0.008'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0041', 'upperLimit': '0.0054'}, {'value': '.01', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.013'}, {'value': '0.007', 'groupId': 'OG002', 'lowerLimit': '0.005', 'upperLimit': '0.008'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0039', 'upperLimit': '0.0053'}, {'value': '.014', 'groupId': 'OG001', 'lowerLimit': '0.011', 'upperLimit': '0.017'}, {'value': '0.006', 'groupId': 'OG002', 'lowerLimit': '0.005', 'upperLimit': '0.008'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '0.005', 'groupId': 'OG000', 'lowerLimit': '0.0044', 'upperLimit': '0.0056'}, {'value': '.01', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.016'}, {'value': '0.009', 'groupId': 'OG002', 'lowerLimit': '0.007', 'upperLimit': '0.011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.', 'unitOfMeasure': 'Units on a Theoretical Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Feel Drink', 'categories': [{'measurements': [{'value': '15.89', 'spread': '15.45', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '22.00', 'spread': '17.34', 'groupId': 'OG002'}]}]}, {'title': 'Feel High', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '2.00', 'spread': '3.95', 'groupId': 'OG002'}]}]}, {'title': 'Like Drink', 'categories': [{'measurements': [{'value': '12.33', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '25.33', 'spread': '20.30', 'groupId': 'OG002'}]}]}, {'title': 'Want Drink', 'categories': [{'measurements': [{'value': '17.22', 'spread': '17.48', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '23.50', 'spread': '20.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Feel Drink', 'categories': [{'measurements': [{'value': '17.44', 'spread': '11.68', 'groupId': 'OG000'}, {'value': '10.50', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '28.50', 'spread': '20.11', 'groupId': 'OG002'}]}]}, {'title': 'Feel High', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '4.02', 'groupId': 'OG002'}]}]}, {'title': 'Like Drink', 'categories': [{'measurements': [{'value': '16.78', 'spread': '23.55', 'groupId': 'OG000'}, {'value': '9.50', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '27.33', 'spread': '22.14', 'groupId': 'OG002'}]}]}, {'title': 'Want Drink', 'categories': [{'measurements': [{'value': '19.22', 'spread': '19.57', 'groupId': 'OG000'}, {'value': '15.50', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '32.33', 'spread': '24.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Feel Drink', 'categories': [{'measurements': [{'value': '10.67', 'spread': '8.79', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '20.17', 'spread': '11.50', 'groupId': 'OG002'}]}]}, {'title': 'Feel High', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '4.18', 'groupId': 'OG002'}]}]}, {'title': 'Like Drink', 'categories': [{'measurements': [{'value': '16.89', 'spread': '21.97', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '24.00', 'spread': '18.28', 'groupId': 'OG002'}]}]}, {'title': 'Want Drink', 'categories': [{'measurements': [{'value': '11.11', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '15.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '26.00', 'spread': '27.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Feel Drink', 'categories': [{'measurements': [{'value': '12.67', 'spread': '10.97', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '17.17', 'spread': '13.83', 'groupId': 'OG002'}]}]}, {'title': 'Feel High', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Like Drink', 'categories': [{'measurements': [{'value': '10.78', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '20.50', 'spread': '21.14', 'groupId': 'OG002'}]}]}, {'title': 'Want Drink', 'categories': [{'measurements': [{'value': '8.44', 'spread': '13.60', 'groupId': 'OG000'}, {'value': '15.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '15.17', 'spread': '11.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Breath Alcohol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.029', 'spread': '0.013', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.004', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.030', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.008', 'groupId': 'OG000'}, {'value': '0.041', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.034', 'spread': '0.021', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.007', 'groupId': 'OG000'}, {'value': '0.023', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '0.037', 'spread': '0.015', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '125.00', 'spread': '13.65', 'groupId': 'OG000'}, {'value': '129.00', 'spread': '19.80', 'groupId': 'OG001'}, {'value': '124.00', 'spread': '8.90', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '126.67', 'spread': '12.35', 'groupId': 'OG000'}, {'value': '140.00', 'spread': '9.90', 'groupId': 'OG001'}, {'value': '121.67', 'spread': '6.53', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '123.33', 'spread': '10.39', 'groupId': 'OG000'}, {'value': '130.00', 'spread': '18.38', 'groupId': 'OG001'}, {'value': '124.33', 'spread': '8.73', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '125.44', 'spread': '12.17', 'groupId': 'OG000'}, {'value': '131.50', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '127.50', 'spread': '11.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '73.56', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '82.00', 'spread': '12.73', 'groupId': 'OG001'}, {'value': '77.67', 'spread': '6.71', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '74.00', 'spread': '9.49', 'groupId': 'OG000'}, {'value': '88.50', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '77.00', 'spread': '8.51', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '74.22', 'spread': '7.08', 'groupId': 'OG000'}, {'value': '85.50', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '80.33', 'spread': '5.09', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '74.00', 'spread': '8.89', 'groupId': 'OG000'}, {'value': '82.00', 'spread': '8.49', 'groupId': 'OG001'}, {'value': '80.50', 'spread': '9.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.', 'unitOfMeasure': 'Millimeter of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules. Methylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'OG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'classes': [{'title': 'Methylphenidate (0 mg)', 'categories': [{'measurements': [{'value': '75.89', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '66.50', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '75.83', 'spread': '11.41', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (20 mg)', 'categories': [{'measurements': [{'value': '83.44', 'spread': '12.63', 'groupId': 'OG000'}, {'value': '80.50', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '84.83', 'spread': '11.43', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (40 mg)', 'categories': [{'measurements': [{'value': '81.67', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '73.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '88.83', 'spread': '13.01', 'groupId': 'OG002'}]}]}, {'title': 'Methylphenidate (60 mg)', 'categories': [{'measurements': [{'value': '83.89', 'spread': '13.04', 'groupId': 'OG000'}, {'value': '80.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '98.50', 'spread': '21.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'FG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'FG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': '0 mg Methylphenidate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': '20 mg Methylphenidate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': '40 mg Methylphenidate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': '60 mg Methylphenidate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'One subject left due to personal reasons unrelated to study-procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nPlacebos: Subjects will receive placebo capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'BG001', 'title': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.'}, {'id': 'BG002', 'title': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.\n\nAlcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.\n\nDuloxetine: Subjects will receive duloxetine capsules.\n\nMethylphenidate: Subjects will receive methylphenidate capsules.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.27', 'spread': '9.00', 'groupId': 'BG000'}, {'value': '32.50', 'spread': '13.44', 'groupId': 'BG001'}, {'value': '30.25', 'spread': '10.66', 'groupId': 'BG002'}, {'value': '30.48', 'spread': '9.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-31', 'size': 483122, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-26T14:56', 'hasProtocol': True}, {'date': '2023-02-15', 'size': 244856, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-26T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2018-06-22', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2018-06-29', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reinforcing Effects (Pre-Alcohol Dose Consumption)', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.'}, {'measure': 'Reinforcing Effects (Post-Alcohol Dose Consumption)', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol'}, {'measure': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol'}, {'measure': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol'}, {'measure': 'Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol'}, {'measure': 'Breath Alcohol Level', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.'}, {'measure': 'Heart Rate', 'timeFrame': 'Measured at each methylphenidate dose-level over approximately four weeks of participation.', 'description': 'Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.', 'detailedDescription': 'Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020.\n\nFor both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study.\n\nSubjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.\n\nPlease note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to speak/read English\n* not seeking treatment at the time of the study\n* one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days\n* recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder\n* ECG within normal limits\n* otherwise healthy\n* body mass index of 19-35\n* females using an effective form of birth control and not pregnant or breast feeding\n* judged by the medical staff to be psychiatrically and physically healthy\n* able to abstain from alcohol for 12 hours prior to session\n\nExclusion Criteria\n\n* Not under 21 years of age or over 55 years of age\n* no contraindications/allergies to alcohol, duloxetine, or methylphenidate'}, 'identificationModule': {'nctId': 'NCT03575403', 'acronym': 'BED[IN]:36', 'briefTitle': 'Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study', 'orgStudyIdInfo': {'id': '44796'}, 'secondaryIdInfos': [{'id': 'R01AA026255', 'link': 'https://reporter.nih.gov/quickSearch/R01AA026255', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received oral placebo capsules one time daily.', 'interventionNames': ['Drug: Alcohol', 'Drug: Placebos', 'Drug: Methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'Duloxetine (60 MG)', 'description': 'Subjects received 60 mg of oral duloxetine one time daily.', 'interventionNames': ['Drug: Duloxetine (60 MG)']}, {'type': 'EXPERIMENTAL', 'label': 'Duloxetine (30 MG)', 'description': 'Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm.', 'interventionNames': ['Drug: Duloxetine (30 MG)']}], 'interventions': [{'name': 'Alcohol', 'type': 'DRUG', 'description': 'In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.', 'armGroupLabels': ['Placebo']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Subjects will receive oral placebo capsules.', 'armGroupLabels': ['Placebo']}, {'name': 'Duloxetine (60 MG)', 'type': 'DRUG', 'description': 'Subjects will receive 60-mg of oral duloxetine capsules.', 'armGroupLabels': ['Duloxetine (60 MG)']}, {'name': 'Methylphenidate', 'type': 'DRUG', 'description': 'Subjects will receive methylphenidate capsules.', 'armGroupLabels': ['Placebo']}, {'name': 'Duloxetine (30 MG)', 'type': 'DRUG', 'description': 'Subjects will receive 30-mg of oral duloxetine capsules.', 'armGroupLabels': ['Duloxetine (30 MG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40511', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Craig Rush, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Craig Rush', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Craig Rush', 'investigatorAffiliation': 'University of Kentucky'}}}}