Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-27 @ 3:44 PM
Study NCT ID:
NCT03224468
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Medical Marijuana on Neurocognition and Escalation of Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064086', 'term': 'Medical Marijuana'}, {'id': 'C587251', 'term': 'nabiximols'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgilman1@mgh.harvard.edu', 'phone': '617-643-7293', 'title': 'Jodi Gilman, PhD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants used variety of commercial medical cannabis products of their choice, at self-titrated doses; We do not attempt to comment on pharmacologic effects, risks, or benefits, of specific cannabinoids at specific doses; Inclusion based on self-reported symptoms, which may limit generalizability to those with formal diagnoses; Homogenous sample in terms of race, ethnicity; high dropout in the MMC group between randomization and baseline, reflecting cost and burden of obtaining a MMC.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for 3 months.', 'description': 'Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 90, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 60, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Psychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General disorders and conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervous system symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury and poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Cardiac Ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.40', 'pValueComment': 'The p-value is adjusted for multiple comparisons using per Benjamini \\& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.', 'nonInferiorityComment': 'Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.4', 'pValueComment': 'The p-value is adjusted for multiple comparisons using per Benjamini \\& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'estimateComment': 'Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).', 'groupDescription': "The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.', 'nonInferiorityComment': 'Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.24', 'pValueComment': 'The p-value is adjusted for multiple comparisons using per Benjamini \\& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'estimateComment': 'Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.', 'nonInferiorityComment': 'Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks, 4 Weeks, and 12 Weeks', 'description': 'For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.39', 'pValueComment': 'The p-value is adjusted for multiple comparisons using per Benjamini \\& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'estimateComment': 'Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.', 'nonInferiorityComment': 'Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 61 participants out of 186 total who intended to use medical marijuana to address concerns for pain.'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '-0.43', 'pValueComment': 'The p-value is adjusted for multiple comparisons using per Benjamini \\& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'estimateComment': 'Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.', 'nonInferiorityComment': 'Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\\<0.05.'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 42 participants out of 186 total who intended to use medical marijuana to address concerns for insomnia.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The Short Form-12 Health Survey (SF-12) Physical Health Summary Scale was used to assess self-report of physical health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. There are no range limits to this measure. Higher scores indicate better physical health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The Short Form 12 Health Survey (SF-12) Mental Health Summary Scale was used to assess self-report of mental health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. This measure has no range limits. Higher scores indicate better mental health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '43', 'groupId': 'OG000'}, {'value': '77', 'spread': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.7', 'estimateComment': 'Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Congruency cost was assessed wth the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range of this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for incongruent trials (i.e., trials where the direction of the arrow differs from the side it appears) minus the median latency for congruent trials (i.e., trials where the direction of the arrow matches the side it appears). Positive values indicate faster responses to congruent trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'spread': '90', 'groupId': 'OG000'}, {'value': '162', 'spread': '107', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.1', 'ciLowerLimit': '-45.9', 'ciUpperLimit': '-2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.2', 'estimateComment': 'Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Switching cost was assessed with the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for blocks of switching trials (i.e., blocks of trials where the response rule switches between indicating the direction of the arrow or the position of the arrow) minus the median latency for blocks of non-switching trials (i.e., blocks of trials where the response rule is always either to indicate the direction of the arrow or the position of the arrow across all trials). Positive scores indicate faster responses to non-switching trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.076', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '0.044', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciLowerLimit': '-0.007', 'ciUpperLimit': '0.011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.005', 'estimateComment': 'Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Discriminability was assessed with the Rapid Visual Information Processing (RVP) Task, which assesses sustained attention and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of response times and accuracy using the EZ-Diffusion model. There are no limits for this measure. Higher scores indicate that subjects can better discriminator between targets and distractors. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 177 participants out of 186 total who completed the RVP module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Total errors were assessed with the Paired Associates Learning (PAL) task, which assesses visual memory and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 70 errors. Higher scores indicate that the subject committed more errors (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'Number of errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 177 participants out of 186 total who completed the PAL module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.0', 'estimateComment': 'Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Repetition errors were assessed with the Spatial Working Memory (SWM) task, which assesses spatial working memory and executive function. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 63 errors. Higher scores indicate that more repetition errors were committed (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'Number of errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 177 participants out of 186 total who completed the ? module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': "Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'estimateComment': 'Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Discriminability was assessed with the Verbal Recognition Memory task (VRM), which assess verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of hit and false alarm rates using a signal detection theory (SDT) model.There are no limits for this measure. Higher scores indicate that a subject was able to better discriminate between previously studied and novel words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 171 participants out of 186 total who completed the VRM module of the CANTAB at weeks 4 and 12.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'OG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'estimateComment': 'Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).', 'groupDescription': "The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Free Recall Memory was assessed with the Verbal Recognition Memory task (VRM), which assesses verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 18 words recalled. Higher scores indicate that subjects were able to correctly recall more previously studied words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.', 'unitOfMeasure': 'Total recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is restricted to the subset of 175 participants out of 186 total who completed the free recall VRM module of the CANTAB at weeks 4 and 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'FG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Did not obtain MM card', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Cannabis Use Disorder at Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.\n\nMedical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.'}, {'id': 'BG001', 'title': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '37.2', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'title': 'High School', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Part College', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'College 2 Years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'College 4 Years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Part Grad School', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Years', 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '16.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cannabis Use Frequency', 'classes': [{'categories': [{'title': 'Used less than weekly', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Used weekly or more', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Complaint', 'classes': [{'categories': [{'title': 'Pain', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Insomnia', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Anxiety/Depression', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-28', 'size': 334753, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-28T09:45', 'hasProtocol': True}, {'date': '2020-04-22', 'size': 221972, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-13T11:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2017-07-17', 'resultsFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-08', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 Weeks, 4 Weeks, and 12 Weeks', 'description': 'For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}], 'secondaryOutcomes': [{'measure': 'Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The Short Form-12 Health Survey (SF-12) Physical Health Summary Scale was used to assess self-report of physical health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. There are no range limits to this measure. Higher scores indicate better physical health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks', 'timeFrame': '2 weeks, 4 weeks, and 12 weeks', 'description': 'The Short Form 12 Health Survey (SF-12) Mental Health Summary Scale was used to assess self-report of mental health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. This measure has no range limits. Higher scores indicate better mental health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Congruency cost was assessed wth the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range of this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for incongruent trials (i.e., trials where the direction of the arrow differs from the side it appears) minus the median latency for congruent trials (i.e., trials where the direction of the arrow matches the side it appears). Positive values indicate faster responses to congruent trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Switching cost was assessed with the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for blocks of switching trials (i.e., blocks of trials where the response rule switches between indicating the direction of the arrow or the position of the arrow) minus the median latency for blocks of non-switching trials (i.e., blocks of trials where the response rule is always either to indicate the direction of the arrow or the position of the arrow across all trials). Positive scores indicate faster responses to non-switching trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Discriminability was assessed with the Rapid Visual Information Processing (RVP) Task, which assesses sustained attention and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of response times and accuracy using the EZ-Diffusion model. There are no limits for this measure. Higher scores indicate that subjects can better discriminator between targets and distractors. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Total errors were assessed with the Paired Associates Learning (PAL) task, which assesses visual memory and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 70 errors. Higher scores indicate that the subject committed more errors (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Repetition errors were assessed with the Spatial Working Memory (SWM) task, which assesses spatial working memory and executive function. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 63 errors. Higher scores indicate that more repetition errors were committed (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': "Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks", 'timeFrame': '4 weeks and 12 weeks', 'description': 'Discriminability was assessed with the Verbal Recognition Memory task (VRM), which assess verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of hit and false alarm rates using a signal detection theory (SDT) model.There are no limits for this measure. Higher scores indicate that a subject was able to better discriminate between previously studied and novel words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}, {'measure': 'Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Free Recall Memory was assessed with the Verbal Recognition Memory task (VRM), which assesses verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 18 words recalled. Higher scores indicate that subjects were able to correctly recall more previously studied words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical marijuana', 'cannabis', 'pain', 'insomnia', 'depression', 'anxiety', 'addiction', 'dependence', 'neurocognition', 'MRI'], 'conditions': ['Pain', 'Insomnia', 'Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '38746368', 'type': 'DERIVED', 'citation': 'Burdinski D, Kodibagkar A, Potter K, Schuster R, Evins AE, Ghosh S, Gilman J. Impact of year-long cannabis use for medical symptoms on brain activation during cognitive processes. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306516. doi: 10.1101/2024.04.29.24306516.'}, {'pmid': '37625034', 'type': 'DERIVED', 'citation': 'Livne O, Potter KW, Schuster RM, Gilman JM. Longitudinal Associations Between Cannabis Use and Cognitive Impairment in a Clinical Sample of Middle-Aged Adults Using Cannabis for Medical Symptoms. Cannabis Cannabinoid Res. 2024 Jun;9(3):e933-e938. doi: 10.1089/can.2022.0310. Epub 2023 Aug 25.'}, {'pmid': '37289502', 'type': 'DERIVED', 'citation': 'Weiss JH, Tervo-Clemmens B, Potter KW, Evins AE, Gilman JM. The Cannabis Effects Expectancy Questionnaire-Medical (CEEQ-M): Preliminary psychometric properties and longitudinal validation within a clinical trial. Psychol Assess. 2023 Aug;35(8):659-673. doi: 10.1037/pas0001244. Epub 2023 Jun 8.'}, {'pmid': '37068366', 'type': 'DERIVED', 'citation': 'Gilman JM, Potter K, Schuster RM, Hoeppner BB, Evins AE. Cannabis use for medical symptoms: Patterns over the first year of use. Addict Behav. 2023 Sep;144:107719. doi: 10.1016/j.addbeh.2023.107719. Epub 2023 Apr 13.'}, {'pmid': '36638745', 'type': 'DERIVED', 'citation': 'Tervo-Clemmens B, Schmitt W, Wheeler G, Cooke ME, Schuster RM, Hickey S, Pachas GN, Evins AE, Gilman JM. Cannabis use and sleep quality in daily life: An electronic daily diary study of adults starting cannabis for health concerns. Drug Alcohol Depend. 2023 Feb 1;243:109760. doi: 10.1016/j.drugalcdep.2022.109760. Epub 2022 Dec 29.'}, {'pmid': '35302633', 'type': 'DERIVED', 'citation': 'Gilman JM, Schuster RM, Potter KW, Schmitt W, Wheeler G, Pachas GN, Hickey S, Cooke ME, Dechert A, Plummer R, Tervo-Clemmens B, Schoenfeld DA, Evins AE. Effect of Medical Marijuana Card Ownership on Pain, Insomnia, and Affective Disorder Symptoms in Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e222106. doi: 10.1001/jamanetworkopen.2022.2106.'}]}, 'descriptionModule': {'briefSummary': 'This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.', 'detailedDescription': 'This trial is a randomized, longitudinal study of medical marijuana (MM) that will: (1) characterize the impact of MM on indices of addiction, such as CUD, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of MM use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain structure and function. This study will enroll 200 adults with no prior history of CUD or heavy marijuana use, who express interest in using MM to treat pain, insomnia, anxiety, and/or depression. Participants will be randomly assigned to either an active MM arm (n = 100), or to a waitlist control arm (WLC) (n = 100). Participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for MM use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive performance. Urine collected at each visit will be assessed with quantitative assays. MRI scans will be collected to longitudinally investigate possible brain changes associated with MM use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant eligibility is based on self-representation of gender identity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women aged 18-65 years, inclusive;\n2. Competent and willing to provide written informed consent;\n3. Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms.\n4. Not in possession of a medical marijuana card, but expressing intent to get one.\n5. Able to communicate in English language.\n\nExclusion Criteria:\n\n1. Current daily marijuana use (prior to enrollment)\n2. Current substance use disorders (e.g. cocaine, opiate, stimulant). Light to moderate alcohol use is permitted (defined as 16 or less on the AUDIT), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. Participants cannot meet current SCID criteria for a use disorder on any illicit substance other than nicotine.\n3. Pregnant (verified by a urine test).\n4. In the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.'}, 'identificationModule': {'nctId': 'NCT03224468', 'acronym': 'MMNE', 'briefTitle': 'Effect of Medical Marijuana on Neurocognition and Escalation of Use', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Medical Marijuana on Neurocognition and Escalation of Use', 'orgStudyIdInfo': {'id': '2015P001600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Marijuana Arm', 'description': 'This group can begin using medical marijuana immediately.', 'interventionNames': ['Drug: Medical Marijuana']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control Arm', 'description': 'This group agrees to wait 3 months before using medical marijuana.'}], 'interventions': [{'name': 'Medical Marijuana', 'type': 'DRUG', 'otherNames': ['Cannabis'], 'description': 'Patients in this group can choose when, where, and how much medical marijuana to use.', 'armGroupLabels': ['Medical Marijuana Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jodi M Gilman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jodi Gilman', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}