Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT04269993
Status:
TERMINATED
Last Update Posted:
2025-04-01
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth_aston@brown.edu', 'phone': '401-863-6668', 'title': 'Elizabeth Aston, PhD', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse events are reported per intervention (THC, Placebo)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants receive placebo cannabis during one session; sessions will be separated by at least 2 days', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active THC', 'description': 'Participants receive active THC cannabis during one session; sessions will be separated by at least 2 days', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Pain Level Post-vaporization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaporized Cannabis: Placebo Then Active THC', 'description': 'Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days'}, {'id': 'OG001', 'title': 'Vaporized Cannabis: Active THC Then Placebo', 'description': 'Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days'}], 'classes': [{'title': 'Placebo Dose', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.414', 'groupId': 'OG001'}]}]}, {'title': 'Medium THC/Medium CBD Dose', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.121', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)', 'description': "Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible'\n\n\\*higher scores indicate more severe pain", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaporized Cannabis: Placebo Then Active THC', 'description': 'Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days'}, {'id': 'FG001', 'title': 'Vaporized Cannabis: Active THC Then Placebo', 'description': 'Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaporized Cannabis: Placebo Then Active THC', 'description': 'Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days'}, {'id': 'BG001', 'title': 'Vaporized Cannabis: Active THC Then Placebo', 'description': 'Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '57', 'spread': '1.41', 'groupId': 'BG001'}, {'value': '45.67', 'spread': '19.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-07', 'size': 276124, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-01T21:05', 'hasProtocol': True}, {'date': '2021-11-16', 'size': 182840, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-16T17:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Termination of study funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2020-02-12', 'resultsFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-21', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Pain Level Post-vaporization', 'timeFrame': 'at the termination of the cannabis administration procedure (10 minutes post-completion of cannabis administration)', 'description': "Short-Form McGill Pain Questionnaire (SF-MPQ) Scale range to describe current pain level: 0 'none' to 10 'worst possible'\n\n\\*higher scores indicate more severe pain"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design.', 'detailedDescription': 'This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design. Blood will be collected during each session (pre-vaporization, 10 minutes post-vaporization, 60 minutes post-vaporization). Self-reported pain and affect will be assessed at the same time points. The effect of cannabis on pain, affect, and inflammatory biomarkers will be assessed. The study will recruit 76 patients to obtain a final sample of 66 with complete data (15% attrition). This study will be the first to investigate the effect of cannabis on pain, affect, and markers of inflammation among patients with rheumatoid or psoriatic arthritis. This study has the potential to guide clinical decisions pertaining to use of cannabis to treat arthritis symptoms with more precise recommendations regarding cannabis formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. current RA or PA diagnosis with active arthritis not adequately controlled by standard medication\n2. if taking prescribed steroid, non-steroidal anti-inflammatory (NSAID), and/or disease-modifying anti-rheumatic drug (DMARDS; e.g., tumor necrosis factor inhibitors), must be stable use for at least 1 month prior to enrollment (all must be maintained throughout the study)\n3. English-speaking or Spanish-speaking\n4. negative urine toxicology screen\n5. negative pregnancy test\n6. not nursing\n7. use of highly effective birth control during the study for both males and females\n8. prior history of vaping or smoking cannabis\n\n Exclusion Criteria:\n9. greater than zero breath alcohol concentration\n10. presence of psychosis, panic disorder, or suicidal ideation or intent\n11. self-report of serious adverse reaction to cannabis in the past year\n12. smoking more than 20 tobacco cigarettes per day\n13. body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam\n14. all current asthma conditions (i.e., active symptomatic asthma within the last week) or current or past history of asthma triggered by smoking or vaping\n15. current diagnosis of dementia or Parkinson's disease\n16. below cut-off on mental status exam\n17. current diagnosis of moderate to severe traumatic brain injury\n18. current diagnosis of epilepsy\n19. individuals who are immunocompromised (i.e., post-organ transplant, those with an immune deficiency disorder such as HIV, individuals taking immunosuppressant steroids such as continuous prednisone use, and those with lupus)\n20. past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated creatinine\n21. cardiac disease confirmed via clinically significant abnormal findings on an EKG (e.g., arrhythmia, conduction abnormalities, ischemia, or evidence of past myocardial infarction), as well as diagnoses of congestive heart failure or cardiomyopathy\n22. abnormal vital signs\n23. taking any exclusionary medications\n24. presence of any severe cardiovascular, renal, or hepatic disorder\n25. below 18 or above 65 years of age\n26. use of cannabis in the past 1 month before commencement of study participation and throughout the study as confirmed via urine toxicology screening aa) below minimum self-reported pain level on a visual analog scale (VAS) pre-study enrollment via telephone and at baseline due to potential variability in pain level"}, 'identificationModule': {'nctId': 'NCT04269993', 'briefTitle': 'Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis', 'orgStudyIdInfo': {'id': '#1904002430'}, 'secondaryIdInfos': [{'id': 'P20GM130414', 'link': 'https://reporter.nih.gov/quickSearch/P20GM130414', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaporized cannabis: Placebo then Active THC', 'description': 'Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days', 'interventionNames': ['Drug: Cannabis: placebo and medium THC/medium CBD']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized cannabis: Active THC then Placebo', 'description': 'Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days', 'interventionNames': ['Drug: Cannabis: placebo and medium THC/medium CBD']}], 'interventions': [{'name': 'Cannabis: placebo and medium THC/medium CBD', 'type': 'DRUG', 'otherNames': ['Marijuana'], 'description': 'Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).', 'armGroupLabels': ['Vaporized cannabis: Active THC then Placebo', 'Vaporized cannabis: Placebo then Active THC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University School of Public Health', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Elizabeth Aston, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Aston', 'investigatorAffiliation': 'Brown University'}}}}