Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 1:34 PM
Study NCT ID:
NCT03233633
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Marijuana in Combination With Opioids in Palliative and Hospice Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064086', 'term': 'Medical Marijuana'}, {'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jprota@hospice.com', 'phone': '203-848-0660', 'title': 'Jim Prota, Director of Pharmacy', 'organization': 'Connecticut Hospice'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1. This is a single-arm study with only an intervention arm and no control. As a result, it is not possible to draw any causal conclusions. Follow-up studies are needed to further validate the preliminary signals and patterns observed in this study.\n2. There were three patients who experienced a dose change in marijuana from 40mg to 80mg CBD.\n3. Some outcome measurements were missing due to the inability of patients to respond to questions.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from the entire duration for which each patient was enrolled in the study (minimum of 3 days).', 'description': 'The definitions of adverse event and serious adverse event do not differ from the definitions provided by clinicaltrials.gov.\n\nAdverse event data was collected by inpatient-care nursing staff members who continuously monitored each patient throughout their time enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Medical Marijuana Treatment Arm', 'description': 'Because this is a single-arm study, all 66 patients included in the study were in the treatment arm, and were administered medical marijuana. All 66 patients were in hospice care and were followed up until either 1) death or 2) unable to take the medication by mouth anymore. Therefore, the study was expected to have 100% all-cause mortality.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 1, 'seriousNumAtRisk': 66, 'deathsNumAffected': 66, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Reduction of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'Pain level at baseline', 'categories': [{'measurements': [{'value': '2.55', 'spread': '2.46', 'groupId': 'OG000'}]}]}, {'title': 'Pain level on the last day of study', 'categories': [{'measurements': [{'value': '1.40', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minumum 3 days', 'description': 'A numeric pain scale (Units on a scale with the higher number indicating worse pain) was used to assess pain from a range of 0 to 10.', 'unitOfMeasure': 'units on a scale from 0 to 10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in hospice care on regular scheduled opioid administration for pain management.'}, {'type': 'PRIMARY', 'title': 'Reduction in Overall Opioid Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'Opiates administered at Baseline', 'categories': [{'measurements': [{'value': '309.84', 'spread': '775.62', 'groupId': 'OG000'}]}]}, {'title': 'Opiates administered at the end of study', 'categories': [{'measurements': [{'value': '285.54', 'spread': '430.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minimum of 3 days', 'description': "Reduction in overall opioid utilization was measured in units of mg after converting every patient's opioids into equivalent doses (e.g. 2mg of oral dilaudid = 1/4 oral morphine), with a stabilization or reduction in Morphine Mg Equivalents indicating a positive result.", 'unitOfMeasure': 'medical morphine equivalents (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Overall Patient Well Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'Overall well-being at Baseline', 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Overall well-being at the end of study', 'categories': [{'measurements': [{'value': '2.42', 'spread': '2.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. A scale of 1 to 10 was used, where, 1 corresponds to the best well-being and 10 corresponds to the worst well-being.', 'unitOfMeasure': 'score on a scale from 1 to 10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Stabilization With Increased Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'Appetite at Baseline', 'categories': [{'measurements': [{'value': '1.93', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Appetite at the end of study', 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.\n\nAppetite was analyzed as an ordinal variable where 1 = finished 0\\~25% of meal, 2 = 25\\~50% of meal, 3 = 50\\~75% of meal, 4 = 75\\~100% of meal.', 'unitOfMeasure': 'units on a scale from 1 to 4', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improved Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'O2 Saturation at Baseline', 'categories': [{'measurements': [{'value': '94.86', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'O2 Saturation at the end of study', 'categories': [{'measurements': [{'value': '94.10', 'spread': '2.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minimum 3 days', 'description': 'Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction or Prevention of Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'classes': [{'title': 'Nausea at Baseline', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Nausea at the end of study', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used; the scale is a numeric 0-10 scale (Units on a scale where the higher the number the more nausea and vomiting the patient experienced).', 'unitOfMeasure': 'units on a scale from 0 to 10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Less Than 3 Days of Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Enrollment of Terminal Patients with pain and receiving routine opioid therapy within an inpatient Hospice Hospital setting commencing 05/10/2017 and ending 8/5/2022', 'preAssignmentDetails': 'Participants were excluded from participating if they were unable to take orally administered medications.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Treatment Arm', 'description': 'Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting\n\nMedical Marijuana: oral capsule, high ratio CBD:THC'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age in years at time of study enrollment', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '60.25', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis Category', 'classes': [{'title': 'Cancer', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Non-Cancer', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-21', 'size': 4900271, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-03T11:17', 'hasProtocol': True}, {'date': '2016-10-21', 'size': 2284990, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-10-13T13:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2017-07-26', 'resultsFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-04', 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Reduction of Pain', 'timeFrame': 'minumum 3 days', 'description': 'A numeric pain scale (Units on a scale with the higher number indicating worse pain) was used to assess pain from a range of 0 to 10.'}, {'measure': 'Reduction in Overall Opioid Utilization', 'timeFrame': 'minimum of 3 days', 'description': "Reduction in overall opioid utilization was measured in units of mg after converting every patient's opioids into equivalent doses (e.g. 2mg of oral dilaudid = 1/4 oral morphine), with a stabilization or reduction in Morphine Mg Equivalents indicating a positive result."}], 'secondaryOutcomes': [{'measure': 'Improvement in Overall Patient Well Being', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. A scale of 1 to 10 was used, where, 1 corresponds to the best well-being and 10 corresponds to the worst well-being.'}, {'measure': 'Weight Stabilization With Increased Appetite', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.\n\nAppetite was analyzed as an ordinal variable where 1 = finished 0\\~25% of meal, 2 = 25\\~50% of meal, 3 = 50\\~75% of meal, 4 = 75\\~100% of meal.'}, {'measure': 'Improved Oxygen Saturation', 'timeFrame': 'minimum 3 days', 'description': 'Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.'}, {'measure': 'Reduction or Prevention of Nausea and Vomiting', 'timeFrame': 'minimum 3 days', 'description': 'A modified Edmonton Assessment Scale was used; the scale is a numeric 0-10 scale (Units on a scale where the higher the number the more nausea and vomiting the patient experienced).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain management', 'terminally ill'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.\n\nStudy Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.\n\nStudy Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.', 'detailedDescription': "Primary Endpoint: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)\n\nSecondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.\n\nStudy design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.\n\nSubject number: Minimum 66 patients\n\nTreatment Duration: Minimum 5 days\n\nDuration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score will be recorded. For the duration of the study (at least five days) changes in opioid doses and numeric pain scores will be tracked daily.\n\nMarijuana will be administered to the patient via oral route three times daily for at least five days. Patients will receive standardized CBD:THC product provided by NIDA.\n\nOn admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline appetite, depression, nausea, vomiting, overall well-being, and anxiety.\n\nData Tracking: Primary objective tracking will include average numeric pain scores and number of opioid dosage increases and average daily opioid amount (mg equivalents of morphine). Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points from the modified Edmonton Assessment Scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Alert adults\n* requiring opioids for pain management (routine)\n* cancer diagnosis or non-cancer diagnosis as their terminal illness\n\nExclusion Criteria:\n\n* pregnant women\n* Age \\< 18\n* minimally or unresponsive patients unable to take oral medications\n* agitated combative patients'}, 'identificationModule': {'nctId': 'NCT03233633', 'briefTitle': 'Marijuana in Combination With Opioids in Palliative and Hospice Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Connecticut Hospice Inc.'}, 'officialTitle': 'Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients', 'orgStudyIdInfo': {'id': 'WIRB Protocol 20161880-1167645'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single treatment arm', 'description': 'marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting', 'interventionNames': ['Drug: Medical Marijuana']}], 'interventions': [{'name': 'Medical Marijuana', 'type': 'DRUG', 'otherNames': ['cannabidiol', 'medical cannabis'], 'description': 'oral capsule, high ratio CBD:THC', 'armGroupLabels': ['Single treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06405', 'city': 'Branford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Connecticut Hospice Inc.', 'geoPoint': {'lat': 41.27954, 'lon': -72.8151}}], 'overallOfficials': [{'name': 'Theodore Zanker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Connecticut Hospice Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Connecticut Hospice Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Theodore Zanker MD', 'investigatorAffiliation': 'The Connecticut Hospice Inc.'}}}}