Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-21 @ 7:43 PM
Study NCT ID:
NCT02971605
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persisting Effects of Psilocybin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fbarret2@jhmi.edu', 'phone': '4105509777', 'title': 'Frederick Barrett, Ph.D., Principal Investigator', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from Screening to 1-month post psilocybin session (32-70 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Psilocybin', 'description': 'Participants will be administered a 25 mg/70 kg dose of psilocybin\n\nPsilocybin: 25 mg/70 kg Psilocybin', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cardiac event', 'notes': 'Systolic blood pressure higher than 170 mmHg at session timepoint Diastolic blood pressure higher than 100 mmHg at session timepoint. Heart rate higher than 110 beats per minute (BPM) at session timepoint.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thyroid hormone changes', 'notes': 'Change in thyroid-stimulating hormone (TSH) and T4 thyroid hormone levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amygdala Response to Stimuli in the Emotion Recognition Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'One day prior to psilocybin administration.'}, {'id': 'OG001', 'title': '1-week Post Session', 'description': 'One week post psilocybin (25 mg/70 kg) administration.'}, {'id': 'OG002', 'title': '1-month Post Session', 'description': 'One month post psilocybin (25 mg/70 kg) administration.'}], 'classes': [{'title': 'L Amygdala contrast: Happy', 'categories': [{'measurements': [{'value': '0.835', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '-0.759', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '0.619', 'spread': '0.449', 'groupId': 'OG002'}]}]}, {'title': 'L Amygdala contrast: Sad', 'categories': [{'measurements': [{'value': '0.503', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '-0.514', 'spread': '0.635', 'groupId': 'OG001'}, {'value': '0.999', 'spread': '0.563', 'groupId': 'OG002'}]}]}, {'title': 'L Amygdala contrast: Fearful', 'categories': [{'measurements': [{'value': '0.525', 'spread': '0.421', 'groupId': 'OG000'}, {'value': '-0.928', 'spread': '0.696', 'groupId': 'OG001'}, {'value': '0.664', 'spread': '0.584', 'groupId': 'OG002'}]}]}, {'title': 'L Amygdala contrast: Angry', 'categories': [{'measurements': [{'value': '0.514', 'spread': '0.357', 'groupId': 'OG000'}, {'value': '-0.881', 'spread': '0.703', 'groupId': 'OG001'}, {'value': '1.131', 'spread': '0.569', 'groupId': 'OG002'}]}]}, {'title': 'L Amygdala contrast: Neutral', 'categories': [{'measurements': [{'value': '0.794', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '-0.825', 'spread': '0.572', 'groupId': 'OG001'}, {'value': '1.098', 'spread': '0.582', 'groupId': 'OG002'}]}]}, {'title': 'R Amygdala contrast: Happy', 'categories': [{'measurements': [{'value': '0.938', 'spread': '0.388', 'groupId': 'OG000'}, {'value': '-0.052', 'spread': '0.431', 'groupId': 'OG001'}, {'value': '0.749', 'spread': '0.478', 'groupId': 'OG002'}]}]}, {'title': 'R Amygdala contrast: Sad', 'categories': [{'measurements': [{'value': '0.927', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.816', 'spread': '0.444', 'groupId': 'OG002'}]}]}, {'title': 'R Amygdala contrast: Fearful', 'categories': [{'measurements': [{'value': '0.979', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '-0.254', 'spread': '0.481', 'groupId': 'OG001'}, {'value': '0.617', 'spread': '0.563', 'groupId': 'OG002'}]}]}, {'title': 'R Amygdala contrast: Angry', 'categories': [{'measurements': [{'value': '0.834', 'spread': '0.449', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.689', 'spread': '0.454', 'groupId': 'OG002'}]}]}, {'title': 'R Amygdala contrast: Neutral', 'categories': [{'measurements': [{'value': '1.081', 'spread': '0.428', 'groupId': 'OG000'}, {'value': '-0.256', 'spread': '0.358', 'groupId': 'OG001'}, {'value': '0.719', 'spread': '0.476', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.', 'unitOfMeasure': 'BOLD percent signal change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Longitudinal Emotion and Mood Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'One day prior to psilocybin administration.'}, {'id': 'OG001', 'title': '1-week Post Session', 'description': 'One week post psilocybin (25 mg/70 kg) administration.'}, {'id': 'OG002', 'title': '1-month Post Session', 'description': 'One month post psilocybin (25 mg/70 kg) administration.'}], 'classes': [{'title': 'Depression (DASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '0.59', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety (DASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '1.45', 'spread': '0.90', 'groupId': 'OG002'}]}]}, {'title': 'Stress (DASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '3.27', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Joy (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.45', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '5.92', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Content (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.62', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '6.13', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'Pride (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.42', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '5.96', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '5.95', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Love (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.61', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '5.98', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Compassion (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.75', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '6.00', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Amusement (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '5.60', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '5.71', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Awe (DPES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.52', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '6.06', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '5.88', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'Positive Affect (PANAS-X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.18', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '40.64', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '40.18', 'spread': '1.92', 'groupId': 'OG002'}]}]}, {'title': 'Negative Affect (PANAS-X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.09', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '12.36', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '16.09', 'spread': '0.80', 'groupId': 'OG002'}]}]}, {'title': 'Tension (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': 'Depression (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.36', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '2.64', 'spread': '1.03', 'groupId': 'OG002'}]}]}, {'title': 'Anger (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '4.64', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.09', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.72', 'spread': '1.06', 'groupId': 'OG002'}]}]}, {'title': 'Confusion (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.55', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '4.72', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': 'Vigor (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.09', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '21.45', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '22.09', 'spread': '2.15', 'groupId': 'OG002'}]}]}, {'title': 'Mood Disturbance (POMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '-3.55', 'spread': '6.19', 'groupId': 'OG002'}]}]}, {'title': 'State Anxiety (STAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '22.82', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '25.64', 'spread': '2.56', 'groupId': 'OG002'}]}]}, {'title': 'Trait Anxiety (STAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.36', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '28.55', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '25.64', 'spread': '27.55', 'groupId': 'OG002'}]}]}, {'title': 'Extraversion (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '0.183', 'groupId': 'OG002'}]}]}, {'title': 'Agreeableness (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.43', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '0.117', 'groupId': 'OG002'}]}]}, {'title': 'Conscientiousness (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.82', 'spread': '0.172', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '0.159', 'groupId': 'OG002'}]}]}, {'title': 'Neuroticism (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.175', 'groupId': 'OG002'}]}]}, {'title': 'Openness (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.17', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '0.151', 'groupId': 'OG002'}]}]}, {'title': 'Absorption (TAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.176', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.233', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).\n\nDepression Anxiety Stress Scale (DASS): Range 0-56 on all subscales\n\nDispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales\n\nPositive \\& Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales\n\nProfile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)\n\nState Trait Anxiety Inventory (STAI): Range 20-80 on all subscales\n\nTellegen Absorption Scale (TAS): Range 0-34\n\nBig Five Inventory (BFI): Range 1-5 on all subscales', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.'}, {'type': 'SECONDARY', 'title': 'Change in Emotional Functioning Task Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'One day prior to psilocybin administration.'}, {'id': 'OG001', 'title': '1-week Post Session', 'description': 'One week post psilocybin (25 mg/70 kg) administration.'}, {'id': 'OG002', 'title': '1-month Post Session', 'description': 'One month post psilocybin (25 mg/70 kg) administration.'}], 'classes': [{'title': 'Emotion recognition task: Happy', 'categories': [{'measurements': [{'value': '92.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '97.9', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Sad', 'categories': [{'measurements': [{'value': '95.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '93.8', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '94.8', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Fearful', 'categories': [{'measurements': [{'value': '100.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '99.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '97.9', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Angry', 'categories': [{'measurements': [{'value': '97.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '99.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Neutral', 'categories': [{'measurements': [{'value': '93.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '96.9', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '100.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Emotion discrimination: Shapes (Control)', 'categories': [{'measurements': [{'value': '97.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '97.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '95.0', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Emotion discrimination: Faces', 'categories': [{'measurements': [{'value': '87.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '93.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Emotional conflict Stroop: Congruent', 'categories': [{'measurements': [{'value': '99.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '99.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '99.5', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Emotional conflict Stroop: Incongruent', 'categories': [{'measurements': [{'value': '98.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '97.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'These tasks measure emotional responding that may be altered by psilocybin.\n\nEmotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.\n\nEmotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.\n\nEmotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.', 'unitOfMeasure': 'percentage of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Emotional Functioning Tasks Response Time (Milliseconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'One day prior to psilocybin administration.'}, {'id': 'OG001', 'title': '1-week Post Session', 'description': 'One week post psilocybin (25 mg/70 kg) administration.'}, {'id': 'OG002', 'title': '1-month Post Session', 'description': 'One month post psilocybin (25 mg/70 kg) administration.'}], 'classes': [{'title': 'Emotion recognition task: Happy', 'categories': [{'measurements': [{'value': '1670', 'spread': '59.5', 'groupId': 'OG000'}, {'value': '1383', 'spread': '41.2', 'groupId': 'OG001'}, {'value': '1454', 'spread': '45.6', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Sad', 'categories': [{'measurements': [{'value': '1539', 'spread': '53.0', 'groupId': 'OG000'}, {'value': '1458', 'spread': '45.6', 'groupId': 'OG001'}, {'value': '1596', 'spread': '56.8', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Fearful', 'categories': [{'measurements': [{'value': '1061', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '1045', 'spread': '31.8', 'groupId': 'OG001'}, {'value': '1130', 'spread': '40.8', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Angry', 'categories': [{'measurements': [{'value': '1380', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '1193', 'spread': '36.4', 'groupId': 'OG001'}, {'value': '1310', 'spread': '40.9', 'groupId': 'OG002'}]}]}, {'title': 'Emotion recognition task: Neutral', 'categories': [{'measurements': [{'value': '1305', 'spread': '49.1', 'groupId': 'OG000'}, {'value': '1594', 'spread': '49.2', 'groupId': 'OG001'}, {'value': '1017', 'spread': '33.4', 'groupId': 'OG002'}]}]}, {'title': 'Emotion discrimination task: Shapes', 'categories': [{'measurements': [{'value': '977.0', 'spread': '212.9', 'groupId': 'OG000'}, {'value': '1697', 'spread': '414.1', 'groupId': 'OG001'}, {'value': '1735', 'spread': '434.9', 'groupId': 'OG002'}]}]}, {'title': 'Emotion discrimination task: Faces', 'categories': [{'measurements': [{'value': '1803', 'spread': '51.1', 'groupId': 'OG000'}, {'value': '1572', 'spread': '41.1', 'groupId': 'OG001'}, {'value': '1522', 'spread': '35.3', 'groupId': 'OG002'}]}]}, {'title': 'Emotional conflict Stroop: Congruent', 'categories': [{'measurements': [{'value': '613.5', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '606.3', 'spread': '5.88', 'groupId': 'OG001'}, {'value': '603.2', 'spread': '7.18', 'groupId': 'OG002'}]}]}, {'title': 'Emotional conflict Stroop: Incongruent', 'categories': [{'measurements': [{'value': '641.3', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '631.4', 'spread': '7.03', 'groupId': 'OG001'}, {'value': '614.1', 'spread': '6.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-day pre (baseline), 1-week post, 1-month post session', 'description': 'These tasks measure emotional responding that may be altered by psilocybin.\n\nEmotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.\n\nEmotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.\n\nEmotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Psilocybin', 'description': 'Participants will be administered a 25 mg/70 kg dose of psilocybin\n\nPsilocybin: 25 mg/70 kg Psilocybin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Psilocybin', 'description': 'Participants will be administered a 25 mg/70 kg dose of psilocybin\n\nPsilocybin: 25 mg/70 kg Psilocybin'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', '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': 'Education Level', 'classes': [{'categories': [{'title': 'High School/GED', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'College', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Post-Graduate', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-24', 'size': 116749, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-30T14:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-21', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2016-11-22', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-21', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amygdala Response to Stimuli in the Emotion Recognition Test', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.'}], 'secondaryOutcomes': [{'measure': 'Change in Longitudinal Emotion and Mood Questionnaire Scores', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).\n\nDepression Anxiety Stress Scale (DASS): Range 0-56 on all subscales\n\nDispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales\n\nPositive \\& Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales\n\nProfile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)\n\nState Trait Anxiety Inventory (STAI): Range 20-80 on all subscales\n\nTellegen Absorption Scale (TAS): Range 0-34\n\nBig Five Inventory (BFI): Range 1-5 on all subscales'}, {'measure': 'Change in Emotional Functioning Task Accuracy', 'timeFrame': '1 day pre (baseline), 1 week post, and 1 month post session', 'description': 'These tasks measure emotional responding that may be altered by psilocybin.\n\nEmotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.\n\nEmotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.\n\nEmotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.'}, {'measure': 'Change in Emotional Functioning Tasks Response Time (Milliseconds)', 'timeFrame': '1-day pre (baseline), 1-week post, 1-month post session', 'description': 'These tasks measure emotional responding that may be altered by psilocybin.\n\nEmotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.\n\nEmotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.\n\nEmotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin) leads to changes in emotion processing and neural circuitry that may predict repeated self-administration of this drug and underlie an atypical mechanism of abuse liability, which may vitally contribute to the understanding of the potential for abuse and the underlying mechanisms supporting abuse of classic hallucinogens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have given written informed consent\n* Have at least a high-school level of education or equivalent, and be fluent in English\n* Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.\n* Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.\n* Agree not to take any "as needed" medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n* Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n* Have limited lifetime use of hallucinogens\n\nExclusion Criteria:\n\n* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.\n* Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), artificial heart valve, or stroke in the past year\n* Epilepsy with history of seizures\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking psychoactive prescription medication on a regular (e.g., daily) basis\n* Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including mono-amine oxidase inhibitors (MAOIs). For individuals who have intermittent or "as needed" use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.\n* More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table\n* Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder\n* Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)\n* Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder\n* Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Head trauma\n* Claustrophobia incompatible with scanning\n* Cardiac pacemaker\n* Implanted cardiac defibrillator\n* Aneurysm brain clip\n* Inner ear implant\n* Prior history as a metal worker and/or certain metallic objects in the body -- must complete magnetic resonance imaging (MRI) screening form and be approved by MRI technologist before each scan'}, 'identificationModule': {'nctId': 'NCT02971605', 'briefTitle': 'Persisting Effects of Psilocybin', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin', 'orgStudyIdInfo': {'id': 'IRB00102081'}, 'secondaryIdInfos': [{'id': 'R03DA042336', 'link': 'https://reporter.nih.gov/quickSearch/R03DA042336', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psilocybin', 'description': 'Participants will be administered a 25 mg/70 kg dose of psilocybin', 'interventionNames': ['Drug: Psilocybin']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'description': '25 mg/70 kg Psilocybin', 'armGroupLabels': ['Psilocybin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Frederick S Barrett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymized data will be shared with qualified scientists upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}