Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 5:29 PM
Study NCT ID:
NCT00957359
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2009-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Psilocybin Cancer Anxiety Study
Sponsor:
Organization:
Raw JSON
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The niacin dose will be 250mg', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Niacin', 'description': 'Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevations in BP and HR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.14', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '16.93', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '.83', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.43', 'spread': '.83', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.64', 'spread': '.83', 'groupId': 'OG000'}, {'value': '8.44', 'spread': '.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.57', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.60', 'spread': '.90', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'spread': '.92', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'State-Trait Anxiety Inventory (STAI) State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '43.79', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '48.53', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '39.07', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '40.33', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '7', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '47.05', 'spread': '2.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '32.72', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '45.31', 'spread': '2.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '25.73', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '38.11', 'spread': '2.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '30.67', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '37.77', 'spread': '3.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '28.04', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '38.28', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '43.79', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '48.53', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'STAI Trait', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '39.07', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '45.87', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '44', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '46.19', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '32.72', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '45.31', 'spread': '2.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '25.73', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '38.11', 'spread': '2.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). 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The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '30.67', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '37.77', 'spread': '3.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). 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Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.43', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '16.47', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day prior to drug administration 1', 'description': '0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.21', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '12.07', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '14.24', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.84', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '13.02', 'spread': '1.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 2', 'description': '0-21 (higher score more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.25', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '10.05', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.31', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '9.65', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HADS Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.48', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '9.06', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Anxiety Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.71', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-15 (higher score more death anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Anxiety Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '6.57', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '7.85', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-15 (higher score more death anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Transcendence Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '13.64', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '11.27', 'spread': '5.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-60 (higher score more death transcendence)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '0-16 (higher score more hopeless)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Anxiety Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '9.14', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-15 (higher score more death anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Transcendence Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '33.98', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '19.88', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-60 (higher score more death transcendence)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-16 (higher score more hopeless)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-16 (higher score more hopeless)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Demoralization Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '35.71', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '38.07', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-96 (higher score more demoralized)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Demoralization Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '18.79', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '32.79', 'spread': '3.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-96 (higher score more demoralized)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Demoralization Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '19.38', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '24.58', 'spread': '3.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-96 (higher score more demoralized)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Physical Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.14', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '12.53', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Physical Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '12.44', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Physical Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16.77', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '14.14', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Psychological Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '13.57', 'spread': '.66', 'groupId': 'OG000'}, {'value': '12.67', 'spread': '.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Psychological Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.43', 'spread': '.66', 'groupId': 'OG000'}, {'value': '12.28', 'spread': '.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Psychological Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.78', 'spread': '.74', 'groupId': 'OG000'}, {'value': '14.90', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Social Relationships Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '13.62', 'spread': '.85', 'groupId': 'OG000'}, {'value': '13.24', 'spread': '.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Social Relationships Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '14.86', 'spread': '.85', 'groupId': 'OG000'}, {'value': '12.78', 'spread': '.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Social Relationships Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '.95', 'groupId': 'OG000'}, {'value': '13.71', 'spread': '.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Environment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '15.75', 'spread': '.74', 'groupId': 'OG000'}, {'value': '14.93', 'spread': '.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Environment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16.42', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '13.90', 'spread': '.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QoL Environment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Drug intervention\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'OG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Active control\n\nPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg\n\nNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16.96', 'spread': '.82', 'groupId': 'OG000'}, {'value': '15.82', 'spread': '.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg.'}, {'id': 'FG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Psilocybin First, Then Niacin', 'description': 'Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg'}, {'id': 'BG001', 'title': 'Niacin First, Then Psilocybin', 'description': 'Niacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '52', 'spread': '15.03', 'groupId': 'BG000'}, {'value': '60.27', 'spread': '9.45', 'groupId': 'BG001'}, {'value': '56.28', 'spread': '12.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-21', 'size': 224517, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-19T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2009-08-11', 'resultsFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2009-08-11', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-02', 'studyFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HADS Anxiety', 'timeFrame': '2-4 weeks prior to drug administration', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '1 day prior to drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '1 day post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '6 weeks post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '1 day prior to drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '6 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'HADS Anxiety', 'timeFrame': '26 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)'}, {'measure': 'State-Trait Anxiety Inventory (STAI) State', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '1 day prior to drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '1 day post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'HADS Depression', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-21 (higher score more depression)'}, {'measure': 'STAI State', 'timeFrame': '6 weeks post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '1 day prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '1 day post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '6 weeks post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI State', 'timeFrame': '26 weeks post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '1 day prior to drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '1 day post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '6 weeks post drug administration 1', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '1 day prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '1 day post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '6 weeks prior to drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'STAI Trait', 'timeFrame': '6 weeks post drug administration 2', 'description': 'STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).'}, {'measure': 'HADS Depression', 'timeFrame': '1 day prior to drug administration 1', 'description': '0-21 (higher score more depression)'}, {'measure': 'HADS Depression', 'timeFrame': '1 day post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)'}, {'measure': 'HADS Depression', 'timeFrame': '6 weeks post drug administration 1', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)'}, {'measure': 'HADS Anxiety', 'timeFrame': '1 day post drug administration 2', 'description': '0-21 (higher score more anxiety)'}, {'measure': 'HADS Depression', 'timeFrame': '1 day post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)'}, {'measure': 'HADS Depression', 'timeFrame': '6 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)'}, {'measure': 'HADS Depression', 'timeFrame': '26 weeks post drug administration 2', 'description': 'Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)'}], 'secondaryOutcomes': [{'measure': 'Death Anxiety Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-15 (higher score more death anxiety)'}, {'measure': 'Death Anxiety Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-15 (higher score more death anxiety)'}, {'measure': 'Death Transcendence Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-60 (higher score more death transcendence)'}, {'measure': 'Hopelessness', 'timeFrame': 'Baseline', 'description': '0-16 (higher score more hopeless)'}, {'measure': 'Death Anxiety Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-15 (higher score more death anxiety)'}, {'measure': 'Death Transcendence Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-60 (higher score more death transcendence)'}, {'measure': 'Hopelessness', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-16 (higher score more hopeless)'}, {'measure': 'Hopelessness', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-16 (higher score more hopeless)'}, {'measure': 'Demoralization Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '0-96 (higher score more demoralized)'}, {'measure': 'Demoralization Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '0-96 (higher score more demoralized)'}, {'measure': 'Demoralization Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '0-96 (higher score more demoralized)'}, {'measure': 'QoL Physical Health Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Physical Health Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Physical Health Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Psychological Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Psychological Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Psychological Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Social Relationships Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Social Relationships Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Social Relationships Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Environment Scale', 'timeFrame': '2-4 weeks prior to drug administration/ Baseline', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Environment Scale', 'timeFrame': '2 weeks post drug administration 1', 'description': '4-20 (higher score improved quality of life domain)'}, {'measure': 'QoL Environment Scale', 'timeFrame': '26 weeks post drug administration 2', 'description': '4-20 (higher score improved quality of life domain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Anxiety', 'Depression', 'Hallucinogens'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31916890', 'type': 'DERIVED', 'citation': 'Agin-Liebes GI, Malone T, Yalch MM, Mennenga SE, Ponte KL, Guss J, Bossis AP, Grigsby J, Fischer S, Ross S. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol. 2020 Feb;34(2):155-166. doi: 10.1177/0269881119897615. Epub 2020 Jan 9.'}, {'pmid': '27909164', 'type': 'DERIVED', 'citation': 'Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.'}], 'seeAlsoLinks': [{'url': 'http://www.nyucanceranxiety.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.\n\nIt is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-76\n* Current or historical diagnosis of cancer\n* Projected life expectancy of at least one year\n* DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features\n* Any stage of cancer diagnosis\n\nExclusion Criteria:\n\n* Epilepsy\n* Renal disease\n* Diabetes\n* Abnormal liver function\n* Severe cardiovascular disease\n* Malignant Hypertension\n* Baseline blood pressure must be less than or equal to 140/90\n* Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness\n* Current substance use disorder\n* Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers'}, 'identificationModule': {'nctId': 'NCT00957359', 'briefTitle': 'Psilocybin Cancer Anxiety Study', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients', 'orgStudyIdInfo': {'id': '06-954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psilocybin', 'description': 'Drug intervention', 'interventionNames': ['Drug: Psilocybin', 'Drug: Niacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Niacin', 'description': 'Active control', 'interventionNames': ['Drug: Psilocybin', 'Drug: Niacin']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['4-phosphoryloxy-N,N-dimethyltryptamine'], 'description': 'Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg', 'armGroupLabels': ['Niacin', 'Psilocybin']}, {'name': 'Niacin', 'type': 'DRUG', 'description': 'Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg', 'armGroupLabels': ['Niacin', 'Psilocybin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU College of Dentistry Bluestone Center for Clinical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stephen Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}, {'name': 'Anthony Bossis, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Co-Principal Investigator NYU Langone School of Medicine'}, {'name': 'Jeffrey Guss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Co-Principal Investigator NYU Langone School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}