Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-04 @ 12:36 AM
Study NCT ID:
NCT02461693
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dallison@uab.edu', 'phone': '205-975-9169', 'title': 'Dr. David Allison, PI', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Please refer to our publication in Psyhcological Methods'}}, 'adverseEventsModule': {'timeFrame': 'Three months', 'description': 'No adverse events were reported', 'eventGroups': [{'id': 'EG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mood State Score on POMS-2 Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}], 'classes': [{'title': 'Total Mood Displacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '14.08', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Anger-Hostility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Confusion-Bewilderment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Depression-Dejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue-Inertia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Friendliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.47', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '12.97', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Tension-Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.53', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Vigor-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.35', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '13.13', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post pill consumption', 'description': 'Profile of Mood States (POMS-2)- "Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling "right now" on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable." - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are of raw data as presented in our publication'}, {'type': 'PRIMARY', 'title': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.932', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.888', 'spread': '0.017', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication', 'unitOfMeasure': 'Proportion correct', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.'}, {'type': 'PRIMARY', 'title': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}], 'classes': [{'title': 'Number correct (out of 60)', 'categories': [{'measurements': [{'value': '55.9', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Number of False Alarm Hits', 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '5.80', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication', 'unitOfMeasure': 'counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.'}, {'type': 'PRIMARY', 'title': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill\n\nCaffeine: 200mg delivered as pill; one-time dose'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.83', 'spread': '14.02', 'groupId': 'BG000'}, {'value': '29.75', 'spread': '11.39', 'groupId': 'BG001'}, {'value': '31.79', 'spread': '12.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 participants (3 assigned to caffeine and two assigned to placebo) were deemed ineligible for study after participation and were thus excluded from the analysis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants, study personnel interacting with participants, and investigators were blinded. Only the study statistician knew treatment assignments.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2015-06-01', 'resultsFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-13', 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood State Score on POMS-2 Test', 'timeFrame': '30 minutes post pill consumption', 'description': 'Profile of Mood States (POMS-2)- "Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling "right now" on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable." - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.'}, {'measure': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication'}, {'measure': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication'}, {'measure': 'Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit', 'timeFrame': '45 to 105 minutes post pill consumption', 'description': 'Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vigilance', 'Mood', 'Randomized Controlled Trial', 'Probability'], 'conditions': ['Caffeine', 'Affect', 'Cognitive Ability, General', 'Mood']}, 'referencesModule': {'references': [{'pmid': '28406674', 'type': 'RESULT', 'citation': 'George BJ, Li P, Lieberman HR, Pavela G, Brown AW, Fontaine KR, Jeansonne MM, Dutton GR, Idigo AJ, Parman MA, Rubin DB, Allison DB. Randomization to randomization probability: Estimating treatment effects under actual conditions of use. Psychol Methods. 2018 Jun;23(2):337-350. doi: 10.1037/met0000138. Epub 2017 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to examine the effect of expectancy on mood and alertness after consumption of caffeine "treatment" or placebo "control" pill, given that participants know their probability for receiving the caffeine versus placebo pill. Participants will be randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and this probability will be revealed to them before consumption of the assigned pill and subsequent cognitive testing. At the time of consumption, neither study staff administering the intervention nor participants will know for certain which pill is given to each participant. Pill assignment will depend on pre-determined randomization probabilities, which will be provided and assigned by the study statistician. By revealing participants\' individual probability of receiving the caffeine pill, we will induce positive or negative expectancies regarding likelihood for receipt of the caffeine pill. These experimental manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world conditions than would a conventional randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years-old or older\n* available to participate on the dates specified\n* willing to take a caffeine or placebo pills at study session\n* willingness to abstain from caffeine for 12 hours prior to study visit (8:30pm-8:30am)\n* UAB employees or students with some college education (including current enrollment)\n\nExclusion Criteria:\n\n* self-reported use of ADHD medication\n* self-reported use of anxiety medication\n* self-reported use of sleep medication\n* self-reported use of nicotine products\n* self-reported lactose intolerance\n* self-reported uncorrected vision\n* self-reported pregnancy or trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT02461693', 'briefTitle': 'Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Evaluating the Role of Expectations in Response to Caffeine Consumption: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'F150410009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine', 'description': 'One-time treatment with 200mg caffeine pill', 'interventionNames': ['Drug: Caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One-time treatment with lactose-based placebo pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': '200mg delivered as pill; one-time dose', 'armGroupLabels': ['Caffeine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lactose-based pill; one-time dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David B Allison, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Raw de-identified data will be posted as a replication data set on ICPSR after publication of results in a journal. Data will be free to download and accessible to anyone with access to ICPSR replication data sets.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean for Science, School of Public Health', 'investigatorFullName': 'David Allison, Phd', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}