Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 3:01 AM
Study NCT ID:
NCT01964404
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}, {'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mary.F.Brunette@Hitchcock.org', 'phone': '603-646-7019', 'title': 'Dr. Mary F. Brunette', 'organization': 'Dartmouth Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Since past assessment (1-2 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dronabinol and placebo cigarette SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 8, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'SCZ-CUD not randomized', 'description': 'Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Marijuana cigarette and placebo capsule CUD only', 'description': 'CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 14, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dronabinol and placebo cigarette CUD only', 'description': 'CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 10, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo cigarette and placebo capsule CUD only', 'description': 'CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 14, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cannabis Use Disorder - CUD Did not randomize', 'description': 'Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'SCZ only', 'description': 'No drug intervention - Completed Scan 1 and 2', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'SCZ only - Did not complete Scan 2', 'description': 'No drug intervention - Completed Scan 1 but not Scan 2', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Healthy Control -', 'description': 'No drug intervention - Completed Scan 1 and 2', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 14, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Healthy Control - Did not complete Scan 2', 'description': 'No drug intervention - Completed Scan 1 but not Scan 2', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased cannabis withdrawal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental Issues', 'notes': 'This includes dental caries and endodontal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety in MRI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back, shoulder or neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MRI Finding - Nervous System', 'notes': 'Arachnoid cyst, Berry Aneurysm, Leukoencephalopathy, herniation of sella, 1.3 cm cyst, elevated signal hemibrain + pons, benign mass, cystic lesion, lesion, enlargement of pituitary gland, white matter signal abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea or vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'notes': 'Fall, sprained knee, heel abrasion, bruising at IV insertion site', 'stats': [{'groupId': 'EG000', 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0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 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'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Reward Circuit Activation on fMRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'Marijuana cigarette and placebo capsule CUD only', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG004', 'title': 'Dronabinol and placebo cigarette CUD only', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG005', 'title': 'Placebo cigarette and placebo capsule. CUD only', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG006', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}, {'id': 'OG007', 'title': 'Healthy Controls', 'description': 'This group of healthy subjects had no illness and received no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.076', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.127', 'groupId': 'OG002'}, {'value': '0.12', 'spread': '0.058', 'groupId': 'OG003'}, {'value': '0.10', 'spread': '0.087', 'groupId': 'OG004'}, {'value': '0.11', 'spread': '0.081', 'groupId': 'OG005'}, {'value': '0.17', 'spread': '0.094', 'groupId': 'OG006'}, {'value': '0.17', 'spread': '0.121', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.13', 'pValueComment': 'p-FDR', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 hours', 'description': "Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resting State Connectivity Within the Brain Reward Circuitry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'Marijuana cigarette and placebo capsule CUD only', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG004', 'title': 'Dronabinol and placebo cigarette CUD only', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG005', 'title': 'Placebo cigarette and placebo capsule. CUD only', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG006', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}, {'id': 'OG007', 'title': 'Healthy Controls', 'description': 'This group of healthy subjects had no illness and received no intervention'}], 'timeFrame': '1 hour after smoking study drug, 3 hours after oral dronabinol', 'description': 'Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was collected but cannot be compiled and analysis could not be completed due to death of PI and resulting limited resources for scan data compilation and analyses. There are no immediate resources for analysis in the future.'}, {'type': 'SECONDARY', 'title': 'PANSS Positive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '10.6', 'spread': '0.37', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'groupDescription': 'This analysis tested whether the marijuana cigarette group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.62', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.62', 'groupDescription': 'This analysis tested whether the dronabinol group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 hours after oral THC/placebo', 'description': 'Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol'}, {'type': 'SECONDARY', 'title': 'PANSS Negative Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '15.2', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-1', 'ciUpperLimit': '3.45', 'groupDescription': 'This analysis tested whether the marijuana cigarette group had different PANSS Negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.39', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'groupDescription': 'This analysis tested whether the dronabinol group had different PANSS Positive negative scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 hours after oral THC/placebo', 'description': 'Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis tested whether the marijuana cigarette group had different PANSS negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.). Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol.'}, {'type': 'SECONDARY', 'title': 'Cognitive Functioning, Verbal Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'Marijuana cigarette and placebo capsule CUD only', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG004', 'title': 'Dronabinol and placebo cigarette CUD only', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG005', 'title': 'Placebo cigarette and placebo capsule. CUD only', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG006', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}, {'id': 'OG007', 'title': 'Healthy Controls', 'description': 'This group of healthy subjects had no illness and received no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '25.0', 'spread': '4.97', 'groupId': 'OG003'}, {'value': '25.3', 'spread': '6.1', 'groupId': 'OG004'}, {'value': '27.9', 'spread': '4.5', 'groupId': 'OG005'}, {'value': '25.5', 'spread': '8.6', 'groupId': 'OG006'}, {'value': '31.0', 'spread': '3.3', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.98', 'ciLowerLimit': '-16.06', 'ciUpperLimit': '-3.18', 'pValueComment': 'We set threshold of p\\<.01 for statistical significance due to multiple comparisons', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.424', 'groupDescription': 'This analysis tested whether the dronabinol group had different verbal learning scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for pre-drug exposure cognitive functioning'}], 'paramType': 'MEAN', 'timeFrame': '4 hours after oral drug', 'description': 'Cognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drug Experience, Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'SCZ only', 'description': 'This group of subjects did not have CUD and received no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '10.03', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '2.30', 'groupId': 'OG002'}, {'value': '14.31', 'spread': '4.72', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.22', 'groupIds': ['OG000', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.07', 'ciLowerLimit': '-3.62', 'ciUpperLimit': '15.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.94', 'groupDescription': 'This analysis tested whether the marijuana cigarette group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.98', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.88', 'ciLowerLimit': '-5.87', 'ciUpperLimit': '5.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.95', 'groupDescription': 'This analysis tested whether the dronabinol group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 hours after taking oral drug', 'description': 'Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety.\n\nThe time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol'}, {'type': 'SECONDARY', 'title': 'Drug Experience Ratings of Drug Liking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette. SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '21.66', 'groupId': 'OG000'}, {'value': '56.36', 'spread': '20.10', 'groupId': 'OG001'}, {'value': '5.54', 'spread': '3.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.91', 'ciLowerLimit': '10.9', 'ciUpperLimit': '90.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.4', 'groupDescription': 'This analysis tested whether the dronabinol group had different drug experience ratings of liking scores compared to the placebo group. (The marijuana cigarette group was tested separately per our analytic plan.)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.1', 'ciLowerLimit': '8.01', 'ciUpperLimit': '94.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.95', 'groupDescription': 'This analysis tested whether the marijuana cigarette group had different drug liking scores compared to the placebo group. (The dronabinol group was tested separately per our analytic plan.)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 hours after taking oral drug', 'description': 'Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking\n\nThe time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol'}, {'type': 'SECONDARY', 'title': 'Cognitive Function, CPT-IP 2 Digit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Marijuana cigarette and placebo capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'OG001', 'title': 'Dronabinol and placebo cigarette SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'OG002', 'title': 'Placebo cigarette and placebo capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'OG003', 'title': 'Marijuana cigarette and placebo capsule CUD only', 'description': 'CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant'}, {'id': 'OG004', 'title': 'Dronabinol and placebo cigarette CUD only', 'description': 'CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.'}, {'id': 'OG005', 'title': 'Placebo cigarette and placebo capsule CUD only', 'description': 'CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.'}, {'id': 'OG006', 'title': 'SCZ only', 'description': 'No drug intervention - Completed Scan 1 and 2'}, {'id': 'OG007', 'title': 'Healthy Control -', 'description': 'No drug intervention - Completed Scan 1 and 2'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG004'}, {'value': '3.9', 'spread': '0.4', 'groupId': 'OG005'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG006'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hours after oral drug', 'description': 'Cognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function\n\nThe outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cannabis Use Disorder', 'description': 'Participants met criteria for Cannabis Use Disorder (CUD)'}, {'id': 'FG001', 'title': 'Dual Diagnosis (Schizophrenia and Cannabis Use Disorder)', 'description': 'Participants with a Dual Diagnosis of Schizophrenia and Cannabis Use Disorder'}, {'id': 'FG002', 'title': 'Schizophrenia', 'description': 'Participants diagnosed with Schizophrenia'}, {'id': 'FG003', 'title': 'Healthy Controls', 'description': 'Participants with no mental health diagnosis or cannabis use'}, {'id': 'FG004', 'title': 'Marijuana Cigarette and Placebo Capsule CUD Only', 'description': 'Participants with Cannabis Use Disorder (CUD) and randomized to receive Marijuana Cigarette and Placebo Capsule'}, {'id': 'FG005', 'title': 'Dronabinol and Placebo Cigarette CUD Only', 'description': 'Participants met criteria for Cannabis Use Disorder (CUD) and were randomized to Dronabinol and Placebo Cigarette'}, {'id': 'FG006', 'title': 'Placebo Cigarette and Placebo Capsule CUD Only', 'description': 'Participants with a diagnosis of Cannabis Use Disorder (CUD) randomized to Placebo Dronabinol and Placebo Cigarette'}, {'id': 'FG007', 'title': 'Marijuana Cigarette and Placebo Capsule - SCZ-CUD', 'description': 'Participants with Dual Diagnosis of Schizophrenia and Cannabis Use Disorder (SCZ-CUD) and randomized to Marijuana Cigarette and Placebo Capsule - SCZ-CUD'}, {'id': 'FG008', 'title': 'Dronabinol and Placebo Cigarette - SCZ-CUD', 'description': 'Participants diagnosed with Diagnosis Schizophrenia and Cannabis Use Disorder and randomized to Dronabinol and Placebo Cigarette'}, {'id': 'FG009', 'title': 'Placebo Cigarette and Placebo Capsule - SCZ-CUD', 'description': 'Participants diagnosed with Schizophrenia and Cannabis Use Disorder and randomized to placebo Cigarette and Placebo Capsule'}], 'periods': [{'title': 'Pre-Randomization - Scan 1', 'milestones': [{'type': 'STARTED', 'comment': 'Consented and Screened', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Enrolled and Completed Neuropsych Testing', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Completed Scan 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Screen Fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Randomization - Scan 2', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'comment': 'Completed Scan 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Marijuana Cigarette and Placebo Capsule SCZ-CUD', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant with THC'}, {'id': 'BG001', 'title': 'Dronabinol and Placebo Cigarette SCZ-CUD', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.\n\nDronabinol: Capsule with THC'}, {'id': 'BG002', 'title': 'Placebo Cigarette and Placebo Capsule. SCZ-CUD', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nPlacebo: Capsule with no active ingredient'}, {'id': 'BG003', 'title': 'SCZ-CUD Not Randomized', 'description': 'Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized'}, {'id': 'BG004', 'title': 'Marijuana Cigarette and Placebo Capsule CUD Only', 'description': 'CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.\n\nMarijuana: Smoked plant'}, {'id': 'BG005', 'title': 'Dronabinol and Placebo Cigarette CUD Only', 'description': 'CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.'}, {'id': 'BG006', 'title': 'Placebo Cigarette and Placebo Capsule CUD Only', 'description': 'CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.'}, {'id': 'BG007', 'title': 'Cannabis Use Disorder - CUD Did Not Randomize', 'description': 'Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized'}, {'id': 'BG008', 'title': 'SCZ Only', 'description': 'No drug intervention - Completed Scan 1 and 2'}, {'id': 'BG009', 'title': 'SCZ Only - Did Not Complete Scan 2', 'description': 'No drug intervention - Completed Scan 1 but not Scan 2'}, {'id': 'BG010', 'title': 'Healthy Control -', 'description': 'No drug intervention - Completed Scan 1 and 2'}, {'id': 'BG011', 'title': 'Healthy Control - Did Not Complete Scan 2', 'description': 'No drug intervention - Completed Scan 1 but not Scan 2'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '33.00', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '45'}, {'value': '28.42', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '46'}, {'value': '31.55', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '45'}, {'value': '26.75', 'groupId': 'BG003', 'lowerLimit': '21', 'upperLimit': '32'}, {'value': '43.59', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '54'}, {'value': '34.29', 'groupId': 'BG005', 'lowerLimit': '20', 'upperLimit': '49'}, {'value': '31.53', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '46'}, {'value': '34.10', 'groupId': 'BG007', 'lowerLimit': '19', 'upperLimit': '48'}, {'value': '35.55', 'groupId': 'BG008', 'lowerLimit': '19', 'upperLimit': '55'}, {'value': '29.66', 'groupId': 'BG009', 'lowerLimit': '18', 'upperLimit': '44'}, {'value': '33.48', 'groupId': 'BG010', 'lowerLimit': '22', 'upperLimit': '53'}, {'value': '26.5', 'groupId': 'BG011', 'lowerLimit': '18', 'upperLimit': '37'}, {'value': '32.59', 'groupId': 'BG012', 'lowerLimit': '18', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '35', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '120', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '152', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '135', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education, years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '12.45', 'spread': '1.695', 'groupId': 'BG000'}, {'value': '13.92', 'spread': '1.782', 'groupId': 'BG001'}, {'value': '13.82', 'spread': '1.722', 'groupId': 'BG002'}, {'value': '12.75', 'spread': '1.165', 'groupId': 'BG003'}, {'value': '14.12', 'spread': '1.764', 'groupId': 'BG004'}, {'value': '14.35', 'spread': '2.548', 'groupId': 'BG005'}, {'value': '14.35', 'spread': '1.967', 'groupId': 'BG006'}, {'value': '12.8', 'spread': '1.033', 'groupId': 'BG007'}, {'value': '13.33', 'spread': '1.847', 'groupId': 'BG008'}, {'value': '12', 'spread': '1', 'groupId': 'BG009'}, {'value': '17.19', 'spread': '1.777', 'groupId': 'BG010'}, {'value': '14.67', 'spread': '1.155', 'groupId': 'BG011'}, {'value': '14.28', 'spread': '2.304', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Schizophrenia, schizoaffective diagnosis', 'classes': [{'title': 'Schizophrenia disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '27', 'groupId': 'BG012'}]}]}, {'title': 'Schizoaffective disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '36', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PANSS', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '63', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '12.09', 'spread': '3.91', 'groupId': 'BG000'}, {'value': '12.83', 'spread': '3.74', 'groupId': 'BG001'}, {'value': '12.82', 'spread': '3.34', 'groupId': 'BG002'}, {'value': '15.88', 'spread': '4.88', 'groupId': 'BG003'}, {'value': '13.11', 'spread': '3.31', 'groupId': 'BG008'}, {'value': '15.0', 'spread': '2.65', 'groupId': 'BG009'}, {'value': '13.01', 'spread': '3.73', 'groupId': 'BG012'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '63', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '15.82', 'spread': '8.34', 'groupId': 'BG000'}, {'value': '12.0', 'spread': '4.41', 'groupId': 'BG001'}, {'value': '15.09', 'spread': '7.91', 'groupId': 'BG002'}, {'value': '13.63', 'spread': '3.54', 'groupId': 'BG003'}, {'value': '14.61', 'spread': '3.96', 'groupId': 'BG008'}, {'value': '17.66', 'spread': '6.81', 'groupId': 'BG009'}, {'value': '14.19', 'spread': '5.6', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'description': 'Positive and Negative Syndrome Scale; Range 7-49, higher score = higher levels of symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure only collected for subjects with SCZ and SCZ-CUD'}, {'title': 'Days of Cannabis Use in Past 35', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '10.73', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '16.92', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '16.64', 'spread': '10.96', 'groupId': 'BG002'}, {'value': '18.25', 'spread': '14.76', 'groupId': 'BG003'}, {'value': '29.76', 'spread': '10.14', 'groupId': 'BG004'}, {'value': '25.18', 'spread': '12.86', 'groupId': 'BG005'}, {'value': '24.24', 'spread': '11.55', 'groupId': 'BG006'}, {'value': '28.2', 'spread': '10.35', 'groupId': 'BG007'}, {'value': '0', 'spread': '0', 'groupId': 'BG008'}, {'value': '0', 'spread': '0', 'groupId': 'BG009'}, {'value': '0.037', 'spread': '0.192', 'groupId': 'BG010'}, {'value': '0.5', 'spread': '1', 'groupId': 'BG011'}, {'value': '14.85', 'spread': '15.54', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'description': 'Days of cannabis use in past 35, range 0-35 days possible', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Joints Smoked in Past 35 days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '155', 'groupId': 'BG012'}]}], 'categories': [{'measurements': [{'value': '18.41', 'spread': '26.99', 'groupId': 'BG000'}, {'value': '22.19', 'spread': '18.82', 'groupId': 'BG001'}, {'value': '19.70', 'spread': '16.01', 'groupId': 'BG002'}, {'value': '44.09', 'spread': '62.20', 'groupId': 'BG003'}, {'value': '39.4', 'spread': '45.3', 'groupId': 'BG004'}, {'value': '52.2', 'spread': '78.6', 'groupId': 'BG005'}, {'value': '52.2', 'spread': '57.5', 'groupId': 'BG006'}, {'value': '44.8', 'spread': '51.2', 'groupId': 'BG007'}, {'value': '0', 'spread': '0', 'groupId': 'BG008'}, {'value': '0', 'spread': '0', 'groupId': 'BG009'}, {'value': '0.0357', 'spread': '0.188', 'groupId': 'BG010'}, {'value': '0.333', 'spread': '0.577', 'groupId': 'BG011'}, {'value': '26.01', 'spread': '43.45', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of Joints', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline data includes all participants who were enrolled and completed Neuropsych Testing. Groups have been partitioned to reflect individuals who completed Period 1 (Pre-Randomization -Scan 1) and Period 2 (Randomization- Scan 2)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-27', 'size': 1870644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-04T17:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2013-10-15', 'resultsFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-18', 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Reward Circuit Activation on fMRI Scan', 'timeFrame': '3 hours', 'description': "Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome."}, {'measure': 'Resting State Connectivity Within the Brain Reward Circuitry', 'timeFrame': '1 hour after smoking study drug, 3 hours after oral dronabinol', 'description': 'Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)'}], 'secondaryOutcomes': [{'measure': 'PANSS Positive Symptoms', 'timeFrame': '3 hours after oral THC/placebo', 'description': 'Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}, {'measure': 'PANSS Negative Symptoms', 'timeFrame': '3 hours after oral THC/placebo', 'description': 'Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}, {'measure': 'Cognitive Functioning, Verbal Learning', 'timeFrame': '4 hours after oral drug', 'description': 'Cognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}, {'measure': 'Drug Experience, Anxiety', 'timeFrame': '3 hours after taking oral drug', 'description': 'Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety.\n\nThe time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}, {'measure': 'Drug Experience Ratings of Drug Liking', 'timeFrame': '3 hours after taking oral drug', 'description': 'Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking\n\nThe time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}, {'measure': 'Cognitive Function, CPT-IP 2 Digit', 'timeFrame': '4 hours after oral drug', 'description': 'Cognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function\n\nThe outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dronabinol', 'Schizophrenia', 'Dual Diagnosis', 'Substance Abuse', 'Cannabis Use Disorder'], 'conditions': ['Schizophrenia', 'Dual Diagnosis', 'Psychotic Disorder', 'Cannabis Use Disorder']}, 'descriptionModule': {'briefSummary': 'In this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them.', 'detailedDescription': 'Substance use disorders are strikingly common in patients with schizophrenia and contribute to its morbidity and cost to society. We have proposed a neurobiological formulation suggesting that cannabis and other substance use in these patients may ameliorate a dysfunction in the brain reward circuit(thus serving a "self-medication" function), while also worsening the symptoms and course of schizophrenia.\n\nIn this translational research proposal, based on our formulation, we seek to confirm and expand upon data obtained in our pilot study suggesting that cannabis and the cannabinoid agonist dronabinol, given in low dose to patients with schizophrenia and co-occurring cannabis use disorder, will in fact ameliorate the brain reward circuit dysregulation in these patients and, thereby, provide evidence in support of the role of cannabis as a "self-medication" agent for them. Also, by also testing the full range of effects produced by dronabinol (effects on brain reward circuitry assessed with task-based function MRI and resting state connectivity), as well as on reward responsiveness, mood, craving, cognition, psychiatric and extrapyramidal symptoms), we will provide clues as to whether dronabinol should be tried in low doses as an adjunctive agent (with an antipsychotic medication) to limit cannabis use in patients with schizophrenia.\n\nThis study will involve 8 groups of 25 participants each. Groups 1-3 will have diagnoses of schizophrenia and cannabis use disorder; Group 4 will have schizophrenia only, Groups 5-7 will have cannabis use disorder only and Group 8 will be healthy control participants. Following screening and baseline neuropsychiatric testing, participants will have two tests days (T1 and T2) that will include task-based functional MRI, including assessment of resting state connectivity, and measuring a number of other parameters including reward responsiveness, mood, craving, symptoms and cognition. The assessments at T1 will be virtually the same for all groups. At T2 Groups 1-3, and Groups 5-7 will be randomly assigned to one of the following conditions prior to the assessments: receiving 15mg of dronabinol and smoking a placebo marijuana cigarette, receiving a placebo pill and smoking a real marijuana cigarette, or receiving a placebo pill and smoking a placebo marijuana cigarette. Group 4 and Group 8 will receive no drug or placebo at T2. Participants receiving drug will have safety assessments before the drug is administered, after the drug is administered but before leaving the research clinic for the day, and again a week later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroups 1-3 Participants with schizophrenia and a cannabis use disorder\n\n1. Ages 18 - 55 years\n2. Diagnosis of schizophrenia\n3. Diagnosis of cannabis abuse or dependence\n4. Use of cannabis within the month prior to screening\n5. Willing to remain abstinent for the 14 days before the baseline assessments and throughout the two scans.\n6. Psychiatrically stable\n7. Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month\n8. Not seeking treatment for their cannabis use disorder.\n\nGroup 4 - Control participants with schizophrenia\n\n1. Ages 18 - 55 years\n2. Diagnosis of schizophrenia\n3. Willing to remain abstinent as described above\n4. Psychiatrically stable\n5. Treated with a stable dose of an antipsychotic medication (except clozapine) for the past month\n\nGroups 5-7 - Control participants with cannabis use disorder\n\n1. Ages 18 - 55 years\n2. Diagnosis of cannabis abuse or dependence\n3. Use of cannabis within the month prior to screening\n4. Willing to remain abstinent as described above\n5. Not seeking treatment for their cannabis use disorder.\n\nGroup 8 - Healthy control participants\n\n1. Ages 18 - 55 years\n2. Willing to remain abstinent as described above\n\nExclusion criteria:\n\nGroups 1-3 with schizophrenia and a cannabis use disorder\n\n1. Positive symptoms of psychosis (\\> 4 \\[moderate\\]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating \\> 5 for this item.\n2. Cocaine/stimulant use disorder\n3. Pharmacological treatment for addiction\n4. Mental retardation\n5. History of head injury\n6. Metal objects within the body that would contraindicate and MRI\n7. Pregnancy or currently nursing\n8. Uncontrolled medical condition\n9. Taking clozapine\n10. Any condition that would contraindicate use of cannabis or dronabinol.\n11. History of a seizure disorder\n\nGroup 4 - Control participants with schizophrenia\n\n1. Positive symptoms of psychosis (\\> 4 \\[moderate\\]) on any item of the Positive and Negative Syndrome Scale psychosis subscale (once abstinent) except for the hallucination item. We will exclude for a rating \\> 5 for this item.\n2. Any history of a substance use disorder other than nicotine\n3. Pharmacological treatment for addiction\n4. Mental retardation\n5. History of head injury\n6. Metal objects within the body that would contraindicate and MRI\n7. Pregnancy or currently nursing\n8. Uncontrolled medical condition\n9. Taking clozapine\n\nGroups 5-7 - Control participants with cannabis use disorder\n\n1. Axis I psychiatric diagnosis other than a cannabis use disorder\n2. Taking any psychotropic medication\n3. Pharmacological treatment for addiction\n4. Mental retardation\n5. History of head injury\n6. Metal objects within the body that would contraindicate and MRI\n7. Pregnancy or currently nursing\n8. Uncontrolled medical condition\n9. History of a seizure disorder\n\nGroup 8 - Healthy control participants\n\n1. Any Axis I psychiatric diagnosis\n2. Taking any psychotropic medication\n3. Pharmacological treatment for addiction\n4. Mental retardation\n5. History of head injury\n6. Metal objects within the body that would contraindicate and MRI\n7. Pregnancy or currently nursing\n8. Uncontrolled medical condition\n9. Current tobacco smokers'}, 'identificationModule': {'nctId': 'NCT01964404', 'briefTitle': 'Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?', 'orgStudyIdInfo': {'id': 'D14061'}, 'secondaryIdInfos': [{'id': '1R01DA034699-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA034699-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Marijuana cigarette and placebo capsule', 'description': '3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.', 'interventionNames': ['Drug: Marijuana']}, {'type': 'EXPERIMENTAL', 'label': 'Dronabinol and placebo cigarette', 'description': 'Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.', 'interventionNames': ['Drug: Dronabinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cigarette and placebo capsule', 'description': 'Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Marijuana', 'type': 'DRUG', 'otherNames': ['Cannabis'], 'description': 'Smoked plant with THC', 'armGroupLabels': ['Marijuana cigarette and placebo capsule']}, {'name': 'Dronabinol', 'type': 'DRUG', 'otherNames': ['Marinol'], 'description': 'Capsule with THC', 'armGroupLabels': ['Dronabinol and placebo cigarette']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule with no active ingredient', 'armGroupLabels': ['Placebo cigarette and placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Mary F Brunette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Nathan Kline Institute for Psychiatric Research', 'class': 'OTHER'}, {'name': 'University of Vermont', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mary F. Brunette, MD', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}