Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00733993
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2008-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Caffeine and Cocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D000661', 'term': 'Amphetamine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fgmoeller@vcu.edu', 'phone': '804-828-4134', 'title': 'F. Gerard Moeller', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Caffeine', 'description': 'Caffeine\n\nCaffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 Amphetamine', 'description': 'Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale Subjective Rating of Drug Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300 mg'}, {'id': 'OG003', 'title': 'Amphetamine 20 mg', 'description': 'Amphetamine 20 mg'}], 'classes': [{'title': 'Elation: Control (N=10)', 'categories': [{'measurements': [{'value': '8.65', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '9.85', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '13.65', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '10.43', 'spread': '4.48', 'groupId': 'OG003'}]}]}, {'title': 'Elation: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '25.99', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '32.54', 'spread': '7.62', 'groupId': 'OG001'}, {'value': '21.65', 'spread': '5.68', 'groupId': 'OG002'}, {'value': '25.71', 'spread': '6.42', 'groupId': 'OG003'}]}]}, {'title': 'Anxious: Control (N=10)', 'categories': [{'measurements': [{'value': '10.15', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '10.45', 'spread': '5.69', 'groupId': 'OG001'}, {'value': '8.50', 'spread': '4.91', 'groupId': 'OG002'}, {'value': '11.68', 'spread': '4.62', 'groupId': 'OG003'}]}]}, {'title': 'Anxious: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '19.64', 'spread': '6.17', 'groupId': 'OG000'}, {'value': '21.35', 'spread': '6.01', 'groupId': 'OG001'}, {'value': '25.27', 'spread': '7.12', 'groupId': 'OG002'}, {'value': '21.71', 'spread': '5.43', 'groupId': 'OG003'}]}]}, {'title': 'Vigor: Control (N=10)', 'categories': [{'measurements': [{'value': '8.25', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '1.92', 'groupId': 'OG001'}, {'value': '9.78', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '8.28', 'spread': '2.01', 'groupId': 'OG003'}]}]}, {'title': 'Vigor: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '10.42', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '10.85', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '9.27', 'spread': '1.60', 'groupId': 'OG002'}, {'value': '10.31', 'spread': '1.33', 'groupId': 'OG003'}]}]}, {'title': 'Tension: Control (N=10)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '1.53', 'spread': '0.48', 'groupId': 'OG003'}]}]}, {'title': 'Tension: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '1.88', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue: Control (N=10)', 'categories': [{'measurements': [{'value': '3.85', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '3.44', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '3.60', 'spread': '1.07', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '1.17', 'spread': '0.36', 'groupId': 'OG003'}]}]}, {'title': 'Depression: Control (N=10)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.06', 'groupId': 'OG003'}]}]}, {'title': 'Depression: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '1.10', 'spread': '0.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after dose', 'description': 'Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300mg'}, {'id': 'OG003', 'title': 'Amphetamine 20mg', 'description': 'Amphetamine 20mg'}], 'classes': [{'title': 'SBP Control (N=10)', 'categories': [{'measurements': [{'value': '115.64', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '115.9', 'spread': '4.07', 'groupId': 'OG001'}, {'value': '117.36', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '119.27', 'spread': '2.13', 'groupId': 'OG003'}]}]}, {'title': 'SBP Cocaine (N=13)', 'categories': [{'measurements': [{'value': '120.18', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '122.10', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '123.84', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '120.30', 'spread': '1.58', 'groupId': 'OG003'}]}]}, {'title': 'DBP Control (N=10)', 'categories': [{'measurements': [{'value': '74.82', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '75.33', 'spread': '2.72', 'groupId': 'OG001'}, {'value': '77.94', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '77.83', 'spread': '1.45', 'groupId': 'OG003'}]}]}, {'title': 'DBP Cocaine (N=13)', 'categories': [{'measurements': [{'value': '79.66', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '79.98', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '82.81', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '78.16', 'spread': '1.56', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours', 'description': 'Sitting Blood Pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300mg'}, {'id': 'OG003', 'title': 'Amphetamine 20mg', 'description': 'Amphetamine 20mg'}], 'classes': [{'title': 'Control (N=10)', 'categories': [{'measurements': [{'value': '66.10', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '62.47', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '61.33', 'spread': '1.67', 'groupId': 'OG002'}, {'value': '65.55', 'spread': '1.23', 'groupId': 'OG003'}]}]}, {'title': 'Cocaine (N=13)', 'categories': [{'measurements': [{'value': '63.08', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '62.60', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '61.57', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '63.51', 'spread': '2.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours', 'description': 'Sitting heart rate', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Addiction Research Center Inventory Subjective Rating of Drug Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300 mg'}, {'id': 'OG003', 'title': 'Amphetamine 20 mg', 'description': 'Amphetamine 20 mg'}], 'classes': [{'title': 'PCAG: Control (N=10)', 'categories': [{'measurements': [{'value': '3.87', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '3.52', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '3.64', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'PCAG: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '2.95', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '2.43', 'spread': '0.67', 'groupId': 'OG003'}]}]}, {'title': 'A: Control (N=10)', 'categories': [{'measurements': [{'value': '3.20', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '3.80', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '3.22', 'spread': '0.38', 'groupId': 'OG003'}]}]}, {'title': 'A: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '3.69', 'spread': '0.45', 'groupId': 'OG003'}]}]}, {'title': 'BG: Control (N=10)', 'categories': [{'measurements': [{'value': '6.00', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '6.05', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '5.83', 'spread': '0.36', 'groupId': 'OG003'}]}]}, {'title': 'BG: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '5.69', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '5.07', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '5.57', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'MGB: Control (N=10)', 'categories': [{'measurements': [{'value': '4.09', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '5.14', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '4.04', 'spread': '1.28', 'groupId': 'OG003'}]}]}, {'title': 'MGB: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '5.29', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '4.31', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '5.18', 'spread': '1.00', 'groupId': 'OG003'}]}]}, {'title': 'LSD: Control (N=10)', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '1.70', 'spread': '0.41', 'groupId': 'OG003'}]}]}, {'title': 'LSD: Cocaine (N=13)', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '0.98', 'spread': '0.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after dose', 'description': 'Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.\n\nIncludes the following subscales:\n\nMorphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300 mg'}, {'id': 'OG003', 'title': 'Amphetamine 20 mg', 'description': 'Amphetamine 20 mg'}], 'classes': [{'title': 'Feel effects:Control (N=10)', 'categories': [{'measurements': [{'value': '16.75', 'spread': '7.58', 'groupId': 'OG000'}, {'value': '20.25', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '9.45', 'spread': '4.97', 'groupId': 'OG002'}, {'value': '11.37', 'spread': '4.93', 'groupId': 'OG003'}]}]}, {'title': 'Feel effects:Cocaine (N=13)', 'categories': [{'measurements': [{'value': '17.30', 'spread': '5.80', 'groupId': 'OG000'}, {'value': '20.73', 'spread': '5.95', 'groupId': 'OG001'}, {'value': '17.62', 'spread': '5.91', 'groupId': 'OG002'}, {'value': '18.68', 'spread': '6.08', 'groupId': 'OG003'}]}]}, {'title': 'Like effects:Control (N=10)', 'categories': [{'measurements': [{'value': '39.92', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '35.62', 'spread': '6.89', 'groupId': 'OG001'}, {'value': '52.17', 'spread': '6.95', 'groupId': 'OG002'}, {'value': '42.25', 'spread': '5.74', 'groupId': 'OG003'}]}]}, {'title': 'Like effects:Cocaine (N=13)', 'categories': [{'measurements': [{'value': '37.18', 'spread': '9.74', 'groupId': 'OG000'}, {'value': '39.94', 'spread': '10.55', 'groupId': 'OG001'}, {'value': '43.75', 'spread': '7.21', 'groupId': 'OG002'}, {'value': '32.04', 'spread': '8.63', 'groupId': 'OG003'}]}]}, {'title': 'High:Control (N=10)', 'categories': [{'measurements': [{'value': '10.77', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '12.17', 'spread': '5.59', 'groupId': 'OG001'}, {'value': '7.17', 'spread': '4.16', 'groupId': 'OG002'}, {'value': '7.17', 'spread': '3.95', 'groupId': 'OG003'}]}]}, {'title': 'High:Cocaine (N=13)', 'categories': [{'measurements': [{'value': '14.35', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '16.14', 'spread': '5.67', 'groupId': 'OG001'}, {'value': '15.87', 'spread': '5.78', 'groupId': 'OG002'}, {'value': '14.64', 'spread': '5.44', 'groupId': 'OG003'}]}]}, {'title': 'Like more:Control (N=10)', 'categories': [{'measurements': [{'value': '25.77', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '25.62', 'spread': '6.54', 'groupId': 'OG001'}, {'value': '32.92', 'spread': '7.01', 'groupId': 'OG002'}, {'value': '25.65', 'spread': '6.08', 'groupId': 'OG003'}]}]}, {'title': 'Like more:Cocaine (N=13)', 'categories': [{'measurements': [{'value': '25.96', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '25.68', 'spread': '8.99', 'groupId': 'OG001'}, {'value': '28.71', 'spread': '8.48', 'groupId': 'OG002'}, {'value': '26.16', 'spread': '8.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after dose', 'description': 'Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Probabalistic Feedback Selection Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300mg'}, {'id': 'OG003', 'title': 'Amphetamine 20mg', 'description': 'Amphetamine 20mg'}], 'classes': [{'title': 'Control (N=10)', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.61', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Cocaine (N=13)', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.56', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '75 minutes after dose', 'description': 'Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.', 'unitOfMeasure': 'accuracy', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Saliva Caffeine and Paraxanthine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'OG001', 'title': 'Caffeine 150 Mg', 'description': '150 MG of Caffeine'}, {'id': 'OG002', 'title': 'Caffeine 300 mg', 'description': 'Caffeine 300mg'}, {'id': 'OG003', 'title': 'Amphetamine 20mg', 'description': 'Amphetamine 20mg'}], 'classes': [{'title': 'Caffeine -30 min Control (N=10)', 'categories': [{'measurements': [{'value': '1000', 'spread': '490', 'groupId': 'OG000'}, {'value': '510', 'spread': '470', 'groupId': 'OG001'}, {'value': '335', 'spread': '110', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 30 min Control (N=10)', 'categories': [{'measurements': [{'value': '983', 'spread': '440', 'groupId': 'OG000'}, {'value': '2715', 'spread': '1110', 'groupId': 'OG001'}, {'value': '2895', 'spread': '998', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 90 min Control (N=10)', 'categories': [{'measurements': [{'value': '984', 'spread': '445', 'groupId': 'OG000'}, {'value': '2225', 'spread': '995', 'groupId': 'OG001'}, {'value': '3510', 'spread': '1001', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 150 min Control (N=10)', 'categories': [{'measurements': [{'value': '984', 'spread': '601', 'groupId': 'OG000'}, {'value': '1910', 'spread': '898', 'groupId': 'OG001'}, {'value': '3270', 'spread': '901', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine -30 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '990', 'spread': '920', 'groupId': 'OG000'}, {'value': '998', 'spread': '820', 'groupId': 'OG001'}, {'value': '1201', 'spread': '997', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 30 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '780', 'spread': '510', 'groupId': 'OG000'}, {'value': '2125', 'spread': '1001', 'groupId': 'OG001'}, {'value': '3510', 'spread': '1220', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 90 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '625', 'spread': '410', 'groupId': 'OG000'}, {'value': '2077', 'spread': '874', 'groupId': 'OG001'}, {'value': '3720', 'spread': '911', 'groupId': 'OG002'}]}]}, {'title': 'Caffeine 150 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '510', 'spread': '322', 'groupId': 'OG000'}, {'value': '1909', 'spread': '605', 'groupId': 'OG001'}, {'value': '3205', 'spread': '697', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine -30 min Control (N=10)', 'categories': [{'measurements': [{'value': '440', 'spread': '155', 'groupId': 'OG000'}, {'value': '274', 'spread': '140', 'groupId': 'OG001'}, {'value': '198', 'spread': '92', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 30 min Control (N=10)', 'categories': [{'measurements': [{'value': '410', 'spread': '240', 'groupId': 'OG000'}, {'value': '301', 'spread': '238', 'groupId': 'OG001'}, {'value': '202', 'spread': '101', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 90 min Control (N=10)', 'categories': [{'measurements': [{'value': '411', 'spread': '219', 'groupId': 'OG000'}, {'value': '402', 'spread': '155', 'groupId': 'OG001'}, {'value': '397', 'spread': '110', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 150 min Control (N=10)', 'categories': [{'measurements': [{'value': '410', 'spread': '143', 'groupId': 'OG000'}, {'value': '411', 'spread': '145', 'groupId': 'OG001'}, {'value': '462', 'spread': '215', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine -30 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '334', 'spread': '205', 'groupId': 'OG000'}, {'value': '401', 'spread': '197', 'groupId': 'OG001'}, {'value': '408', 'spread': '240', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 30 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '320', 'spread': '275', 'groupId': 'OG000'}, {'value': '465', 'spread': '185', 'groupId': 'OG001'}, {'value': '656', 'spread': '280', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 90 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '321', 'spread': '248', 'groupId': 'OG000'}, {'value': '601', 'spread': '233', 'groupId': 'OG001'}, {'value': '985', 'spread': '245', 'groupId': 'OG002'}]}]}, {'title': 'Parathanxine 150 min Cocaine (N=11)', 'categories': [{'measurements': [{'value': '296', 'spread': '252', 'groupId': 'OG000'}, {'value': '605', 'spread': '247', 'groupId': 'OG001'}, {'value': '1014', 'spread': '255', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior to dose, 30/90/150 minutes post dose.', 'description': 'Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.\n\nAnalyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessment was not performed for amphetamine intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cocaine Users', 'description': 'Cocaine users were allocated to different sequence orders for the 5 interventions\n\nAcross five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'FG001', 'title': 'Control Participants', 'description': 'Control participants were allocated to different sequence orders for the 5 interventions\n\nAcross five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cocaine Users', 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'BG001', 'title': 'Control Participants', 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2008-08-12', 'resultsFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-01', 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale Subjective Rating of Drug Effects', 'timeFrame': 'Immediately after dose', 'description': 'Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours', 'description': 'Sitting Blood Pressure'}, {'measure': 'Heart Rate', 'timeFrame': 'Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours', 'description': 'Sitting heart rate'}, {'measure': 'Addiction Research Center Inventory Subjective Rating of Drug Effects', 'timeFrame': 'Immediately after dose', 'description': 'Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.\n\nIncludes the following subscales:\n\nMorphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)'}, {'measure': 'Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects', 'timeFrame': 'Immediately after dose', 'description': 'Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.'}], 'secondaryOutcomes': [{'measure': 'Probabalistic Feedback Selection Task', 'timeFrame': '75 minutes after dose', 'description': 'Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.'}, {'measure': 'Saliva Caffeine and Paraxanthine Levels', 'timeFrame': '30 minutes prior to dose, 30/90/150 minutes post dose.', 'description': 'Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.\n\nAnalyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['substance abuse', 'cocaine', 'caffeine', 'impulsivity'], 'conditions': ['Cocaine Dependence']}, 'referencesModule': {'references': [{'pmid': '25414797', 'type': 'RESULT', 'citation': 'Lane SD, Green CE, Schmitz JM, Rathnayaka N, Fang WB, Ferre S, Moeller FG. Comparison of Caffeine and d-amphetamine in Cocaine-Dependent Subjects: Differential Outcomes on Subjective and Cardiovascular Effects, Reward Learning, and Salivary Paraxanthine. J Addict Res Ther. 2014;5(2):176. doi: 10.4172/2155-6105.1000176.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.', 'detailedDescription': 'Specific Aims:\n\nAim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.\n\nHypotheses related to Aim 1:\n\n1. Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.\n2. Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls\n* At least one cocaine positive urine during screening.\n* Current regular consumption of caffeine.\n* Female subjects: a negative pregnancy test.\n\nExclusion Criteria:\n\n* Current or past DSM-IV Axis I disorder other than substance abuse/ dependence\n* Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine\n* Substance dependence other than cocaine within the last 3 months.\n* Positive breath alcohol.\n* Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing\n* For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.\n* Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.\n* HIV positive.\n* I.Q. below 70.'}, 'identificationModule': {'nctId': 'NCT00733993', 'briefTitle': 'Caffeine and Cocaine', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence', 'orgStudyIdInfo': {'id': 'DA09262'}, 'secondaryIdInfos': [{'id': 'P50DA009262', 'link': 'https://reporter.nih.gov/quickSearch/P50DA009262', 'type': 'NIH'}, {'id': 'DPMCDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Caffeine 150 mg', 'description': 'Caffeine 150 mg', 'interventionNames': ['Drug: Caffeine 150 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3 Amphetamine', 'description': 'Amphetamine', 'interventionNames': ['Drug: Amphetamine']}, {'type': 'EXPERIMENTAL', 'label': '4 Caffeine 300 mg', 'description': 'Caffeine 300 mg', 'interventionNames': ['Drug: Caffeine 300 MG']}], 'interventions': [{'name': 'Caffeine 150 MG', 'type': 'DRUG', 'otherNames': ['Vivarin'], 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'armGroupLabels': ['1 Caffeine 150 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'armGroupLabels': ['2 Placebo']}, {'name': 'Amphetamine', 'type': 'DRUG', 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'armGroupLabels': ['3 Amphetamine']}, {'name': 'Caffeine 300 MG', 'type': 'DRUG', 'otherNames': ['Vivarin'], 'description': 'Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion', 'armGroupLabels': ['4 Caffeine 300 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Frederick G Moeller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Division Chair, Addiction Psychiatry', 'investigatorFullName': 'Frederick Gerard Moeller', 'investigatorAffiliation': 'Virginia Commonwealth University'}}}}