Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT01223404
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nicotinic Modulation of the Default Network
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D008464', 'term': 'Mecamylamine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009636', 'term': 'Norbornanes'}, {'id': 'D001643', 'term': 'Bridged Bicyclo Compounds'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bhahn@mprc.umaryland.edu', 'phone': '4104026112', 'title': 'Dr. Britta Hahn', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day (on each of separate 3 test days)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: Placebo', 'description': 'Participants receive a placebo patch and a placebo capsule.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention: Nicotine', 'description': 'Participants receive a nicotine patch and a placebo capsule.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intervention: Mecamylamine', 'description': 'Participants receive a placebo patch and a mecamylamine capsule.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'A placebo patch and a placebo capsule are administered.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'A nicotine patch and a placebo capsule is administered.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'A placebo patch and a mecamylamine capsule are administered.'}], 'classes': [{'title': 'Attention task reaction time', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000', 'lowerLimit': '485', 'upperLimit': '539'}, {'value': '492', 'groupId': 'OG001', 'lowerLimit': '464', 'upperLimit': '520'}, {'value': '524', 'groupId': 'OG002', 'lowerLimit': '489', 'upperLimit': '559'}]}]}, {'title': 'Working memory task reaction time', 'categories': [{'measurements': [{'value': '541', 'groupId': 'OG000', 'lowerLimit': '516', 'upperLimit': '566'}, {'value': '533', 'groupId': 'OG001', 'lowerLimit': '508', 'upperLimit': '558'}, {'value': '573', 'groupId': 'OG002', 'lowerLimit': '537', 'upperLimit': '609'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'average reaction time on cognitive task performed in the MR scanner', 'unitOfMeasure': 'ms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 healthy male and female adult non-smokers. Only study completers are included, due to the within-subject design.'}, {'type': 'PRIMARY', 'title': 'Signal Detection Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'A placebo patch and a placebo capsule are administered.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'A nicotine patch and a placebo capsule are administered.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'A placebo patch and a mecamylamine capsule are administered.'}], 'classes': [{'title': 'Attention task correct identifications', 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '91.4'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '97.5'}, {'value': '85.2', 'groupId': 'OG002', 'lowerLimit': '79.7', 'upperLimit': '90.7'}]}]}, {'title': 'Working memory task correct detections', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '90.8'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '96.1'}, {'value': '88.6', 'groupId': 'OG002', 'lowerLimit': '87.9', 'upperLimit': '89.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.', 'unitOfMeasure': 'percentage of all targets', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy adult non-smokers (only study completers).'}, {'type': 'PRIMARY', 'title': 'Default Network Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'A placebo patch and a placebo capsule is administered.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'A nicotine patch and a placebo capsule are administered.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'A placebo patch and a mecamylamine capsule are administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG000', 'lowerLimit': '-0.41', 'upperLimit': '-0.17'}, {'value': '-0.24', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '-0.09'}, {'value': '-0.21', 'groupId': 'OG002', 'lowerLimit': '-0.33', 'upperLimit': '-0.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.', 'unitOfMeasure': 'percentage of task-induced signal change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy non-smokers (only study completers).'}, {'type': 'SECONDARY', 'title': 'Subjective State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'A placebo patch and a placebo capsule are administered.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'A nicotine patch and a placebo capsule are administered.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'A placebo patch and a mecamylamine capsule were administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-12.3', 'upperLimit': '-1.1'}, {'value': '-9.9', 'groupId': 'OG001', 'lowerLimit': '-15.4', 'upperLimit': '-4.4'}, {'value': '-5.8', 'groupId': 'OG002', 'lowerLimit': '-12', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'End-of-session subjective state is measured by the Profile of Mood States (POMS). We utilize "Total Mood Disturbance" (TMD) as a summary measure, derived by adding the total scores on the five negative mood scales (tension, depression, anger, fatigue, confusion) and subtracting the score on the one positive mood scale (vigor). The theoretical range of the TMD scale is -32 to 228, with negative values indicating less mood disturbance, i.e., a more positive emotional state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy non-smokers (only study completers).'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'A placebo patch and a placebo capsule were administered.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'A nicotine patch and a placebo capsule were administered.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'A placebo patch and a mecamylamine capsule were administered.'}], 'classes': [{'title': 'Pre-patch', 'categories': [{'measurements': [{'value': '120.2', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '120.9', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '119.3', 'spread': '14.8', 'groupId': 'OG002'}]}]}, {'title': '2 hours post patch', 'categories': [{'measurements': [{'value': '116.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '114.3', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '112.3', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': '4 hours post patch', 'categories': [{'measurements': [{'value': '120.1', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '119.1', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '114.4', 'spread': '11.4', 'groupId': 'OG002'}]}]}, {'title': '6 hours post patch', 'categories': [{'measurements': [{'value': '120.3', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '122.7', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '118.2', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Post-scan', 'categories': [{'measurements': [{'value': '129.7', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '127.4', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '121.5', 'spread': '13.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)', 'description': 'Systolic blood pressure (mmHg)', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy non-smokers'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Placebo', 'description': 'Placebo patch and placebo capsule.'}, {'id': 'OG001', 'title': 'Intervention: Nicotine', 'description': 'Nicotine patch and placebo capsule.'}, {'id': 'OG002', 'title': 'Intervention: Mecamylamine', 'description': 'Placebo patch and mecamylamine capsule.'}], 'classes': [{'title': 'Pre-patch', 'categories': [{'measurements': [{'value': '74.4', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '73.4', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': '2 hours post patch', 'categories': [{'measurements': [{'value': '73.4', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '9.7', 'groupId': 'OG002'}]}]}, {'title': '4 hours post patch', 'categories': [{'measurements': [{'value': '73.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '72.4', 'spread': '6.9', 'groupId': 'OG002'}]}]}, {'title': '6 hours post patch', 'categories': [{'measurements': [{'value': '75.8', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '75.2', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'Post-scan', 'categories': [{'measurements': [{'value': '81.3', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '79.6', 'spread': '9.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).', 'description': 'Diastolic blood pressure in mmHg.', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy non-smokers (only study completers).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo, Nicotine, Mecamylamine', 'description': 'First session: Placebo patch and placebo capsule (filler: methylcellulose) Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule'}, {'id': 'FG001', 'title': 'Nicotine, Placebo, Mecamylamine', 'description': 'First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Mecamylamine capsule'}, {'id': 'FG002', 'title': 'Placebo, Mecamylamine, Nicotine', 'description': 'First session: Placebo patch and Placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)'}, {'id': 'FG003', 'title': 'Nicotine, Mecamylamine, Placebo', 'description': 'First session: Nicotine patch and placebo capsule (filler: methylcellulose) Second session: Placebo patch and Mecamylamine capsule Third session: Placebo patch and Placebo capsule (filler: methylcellulose)'}, {'id': 'FG004', 'title': 'Mecamylamine, Placebo, Nicotine', 'description': 'First session: Placebo patch and Mecamylamine capsule Second session: Placebo patch and Placebo capsule (filler: methylcellulose) Third session: Nicotine patch and Placebo capsule (filler: methylcellulose)'}, {'id': 'FG005', 'title': 'Mecamylamine, Nicotine, Placebo', 'description': 'First session: Placebo patch and Mecamylamine capsule Second session: Nicotine patch and Placebo capsule (filler: methylcellulose) Third session: Placebo patch and Placebo capsule (filler: methylcellulose)'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Non-compliance (slept)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants in each of the six arms received all three interventions (placebo, nicotine, mecamylamine).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '21 healthy non-smokers were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the statistician performing the randomization and the pharmacist dispensing the drugs were aware which drug was given on which day.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2010-10-13', 'resultsFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-24', 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reaction Time', 'timeFrame': '1 day', 'description': 'average reaction time on cognitive task performed in the MR scanner'}, {'measure': 'Signal Detection Performance', 'timeFrame': '1 day', 'description': 'Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.'}, {'measure': 'Default Network Activity', 'timeFrame': '1 day', 'description': 'Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.'}], 'secondaryOutcomes': [{'measure': 'Subjective State', 'timeFrame': '1 day', 'description': 'End-of-session subjective state is measured by the Profile of Mood States (POMS). We utilize "Total Mood Disturbance" (TMD) as a summary measure, derived by adding the total scores on the five negative mood scales (tension, depression, anger, fatigue, confusion) and subtracting the score on the one positive mood scale (vigor). The theoretical range of the TMD scale is -32 to 228, with negative values indicating less mood disturbance, i.e., a more positive emotional state.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)', 'description': 'Systolic blood pressure (mmHg)'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).', 'description': 'Diastolic blood pressure in mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nicotine', 'mecamylamine', 'attention', 'default network', 'fMRI'], 'conditions': ['Magnetic Resonance Imaging', 'Cognition', 'Nicotine', 'Mecamylamine']}, 'referencesModule': {'references': [{'pmid': '17392464', 'type': 'BACKGROUND', 'citation': 'Hahn B, Ross TJ, Yang Y, Kim I, Huestis MA, Stein EA. Nicotine enhances visuospatial attention by deactivating areas of the resting brain default network. J Neurosci. 2007 Mar 28;27(13):3477-89. doi: 10.1523/JNEUROSCI.5129-06.2007.'}]}, 'descriptionModule': {'briefSummary': "Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and schizophrenia, display abnormal regulation of the so-called default network of resting brain function that maintains internally directed thought when the mind is free to wander. There is indication that nicotine may improve attention by aiding the deactivation of the default network, and this mechanism may be of therapeutic benefit for the above disease states. The current project aims at providing a proof of concept by demonstrating that nicotinic drugs modulate default network function. The nicotinic agonist nicotine is hypothesized to improve attention by facilitating the down-regulation of default network activity, and the nicotinic antagonist mecamylamine is hypothesized to impair attention by impeding the down-regulation of default network activity during attentional task performance.", 'detailedDescription': 'This study only enrolls healthy non-smokers. Participants perform attention tasks while undergoing functional Magnetic Resonance Imaging on three separate days. Across the three days, three difference conditions are tested in a double-blind manner, in randomized order. In all test sessions, participants receive a skin patch and swallow a capsule. In one session, both are a placebo. In another, the patch is a low-dose nicotine patch, and the capsule is a placebo. In another session, the patch is a placebo and the capsule contains a low dose of mecamylamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 through 50.\n* Did not consume cigarettes, cigarillos, cigars, or other tobacco or nicotine-containing products more than 20 times in lifetime, and did not use any nicotine-containing product at all within the last two years.\n* Normal or corrected to normal vision (at least 20/80).\n\nExclusion Criteria:\n\n* Presence of metal objects in the body, implanted electronic devices, or any other counter indication for MRI.\n* Claustrophobia.\n* Major psychiatric disorders including mood, anxiety or psychotic disorders.\n* Cardiovascular or cerebrovascular disease, such as history of myocardial infarction, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities.\n* Kidney or liver disease.\n* Hypertension (resting systolic BP above 140 or diastolic above 85 mm Hg).\n* Hypotension (resting systolic BP below 95 or diastolic below 60).\n* Use of any prescription or over-the-counter drug other than supplements and birth control.\n* History of or current neurological illnesses, such as stroke, seizures, dementia or organic brain syndrome.\n* Learning disability, attention deficit disorder, or any other condition that impedes memory and attention.\n* Glaucoma, organic pyloric stenosis, uremia or renal insufficiency.\n* Prostatic hypertrophy, bladder neck obstruction or urethral stricture.\n* Left-handed or ambidextrous.\n* Pregnant as determined by urine test, or breast-feeding.\n* History or current diagnosis of drug or alcohol abuse or dependence.\n* IQ \\< 85 as estimated by the WASI vocabulary subtest.'}, 'identificationModule': {'nctId': 'NCT01223404', 'briefTitle': 'Nicotinic Modulation of the Default Network', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Nicotinic Modulation of the Default Network of Resting Brain Function', 'orgStudyIdInfo': {'id': 'HP-00042696'}, 'secondaryIdInfos': [{'id': 'R21DA027894', 'link': 'https://reporter.nih.gov/quickSearch/R21DA027894', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo, Nicotine, Mecamylamine', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("placebo"), a placebo patch and a placebo capsule is administered.\n\nIn the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered.\n\nIn the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine, Placebo, Mecamylamine', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("nicotine"), a nicotine patch and a placebo capsule is administered.\n\nIn the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered.\n\nIn the third session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, Mecamylamine, Nicotine', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("placebo"), a placebo patch and a placebo capsule is administered.\n\nIn the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered.\n\nIn the third session ("nicotine"), a nicotine patch and a placebo capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine, Mecamylamine, Placebo', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("nicotine"), a nicotine patch and a placebo capsule is administered.\n\nIn the second session ("mecamylamine"), a placebo patch (7 mg/24 hrs) and a mecamylamine capsule is administered.\n\nIn the third session ("placebo"), a placebo patch and a placebo capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}, {'type': 'EXPERIMENTAL', 'label': 'Mecamylamine, Placebo, Nicotine', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.\n\nIn the second session ("placebo"), a placebo patch (7 mg/24 hrs) and a placebo capsule is administered.\n\nIn the third session ("nicotine"), a nicotine patch and a placebo capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}, {'type': 'EXPERIMENTAL', 'label': 'Mecamylamine, Nicotine, Placebo', 'description': 'Participants undergo 3 test sessions:\n\nIn the first session ("mecamylamine"), a placebo patch and a mecamylamine capsule is administered.\n\nIn the second session ("nicotine"), a nicotine patch (7 mg/24 hrs) and a placebo capsule is administered.\n\nIn the third session ("placebo"), a placebo patch and a placebo capsule is administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Nicotine', 'Drug: Mecamylamine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants are administered a placebo patch and a placebo capsule', 'armGroupLabels': ['Mecamylamine, Nicotine, Placebo', 'Mecamylamine, Placebo, Nicotine', 'Nicotine, Mecamylamine, Placebo', 'Nicotine, Placebo, Mecamylamine', 'Placebo, Mecamylamine, Nicotine', 'Placebo, Nicotine, Mecamylamine']}, {'name': 'Nicotine', 'type': 'DRUG', 'otherNames': ['Nicotine CQ'], 'description': 'Participants are administered a nicotine patch (7 mg/24 hrs) and a placebo capsule', 'armGroupLabels': ['Mecamylamine, Nicotine, Placebo', 'Mecamylamine, Placebo, Nicotine', 'Nicotine, Mecamylamine, Placebo', 'Nicotine, Placebo, Mecamylamine', 'Placebo, Mecamylamine, Nicotine', 'Placebo, Nicotine, Mecamylamine']}, {'name': 'Mecamylamine', 'type': 'DRUG', 'description': 'Participants are administered a placebo patch and a capsule containing 7.5 mg of mecamylamine', 'armGroupLabels': ['Mecamylamine, Nicotine, Placebo', 'Mecamylamine, Placebo, Nicotine', 'Nicotine, Mecamylamine, Placebo', 'Nicotine, Placebo, Mecamylamine', 'Placebo, Mecamylamine, Nicotine', 'Placebo, Nicotine, Mecamylamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute on Drug Abuse, Intramural Research Program', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Psychiatric Research Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Britta Hahn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Britta Hahn', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}