Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 9:31 PM
Study NCT ID:
NCT05209867
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'simone.marini@ufl.edu', 'phone': '3522948951', 'title': 'Dr. Simone Marini', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We processed data for individuals with different lengths of CBD exposure (2 months for two individuals; 1 month for one individual). The outcome is calculated at the single-cell level (i.e., the gene expression of each cell, from each sample, is measured), and not at the patient level. The low number of recruited patients makes impossible to draw conclusions at the patient level.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the administration period (2 months)', 'eventGroups': [{'id': 'EG000', 'title': 'CBD Intervention', 'description': 'Participants will self-administer CBD daily for 2 months.\n\nCBD oil: -Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc \\~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).\n\n-The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neck pain', 'notes': 'After the first administration of the CBD, one individual reported pain in the right side of their neck (lymph node area). Our study physician considered the neck pain likely unrelated to CBD, and safe to continue the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Differentially Expressed Genes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBD Intervention', 'description': 'Participants will self-administer CBD daily for 2 months.\n\nCBD oil: -Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc \\~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).\n\n-The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)', 'description': 'Number of genes with a significant fold change before/after CBD in PBMCs (Peripheral Blood Mononuclear Cells) related to inflammation genes, calculated before and after CBD treatment (baseline and 1 month for 1 participant, 2 months for 2 participants).', 'unitOfMeasure': 'Differentially expressed genes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Four individuals completed the assigned intervention. One individual completed one month only. Two individuals completed two months. A fourth individual completed two months but, after protocol and data review, the quality of the provided data was deemed not sufficient (single-cell RNA was not sequenced, gene expression not measured for that individual).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBD Intervention', 'description': 'Participants will self-administer CBD daily for 2 months.\n\nCBD oil: -Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc \\~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).\n\n-The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Completed 1 Month of Intervention', 'comment': 'The individual completed one month of intervention and attended the second visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Completed 2 Months of Intervention', 'comment': 'The individual completed two months of intervention and attended the third visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Four individuals completed the assigned intervention. One individual completed one month only. Two individuals completed two months. A fourth individual completed two months but, after protocol and data review, the quality of the provided data was deemed not sufficient (single-cell RNA was not sequenced, gene expression not measured for that individual).', 'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CBD Intervention', 'description': 'Participants will self-administer CBD daily for 2 months.\n\nCBD oil: -Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc \\~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).\n\n-The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', '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': '10x single-cell gene expression', 'classes': [{'categories': [{'measurements': [{'value': '6553', 'spread': '2111.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of cells per patient', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Procalcitonin', 'classes': [{'categories': [{'measurements': [{'value': '0.013', 'spread': '0.006', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'NG/ML', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sedimentation Rate', 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'MM/HR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-sensitivity CRP', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'MG/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Two individuals completed the assigned intervention. A third individual completed the first month of the assigned intervention. A fourth individual completed the assigned intervention but, after review, the quality of the provided data was deemed not sufficient (single-cell RNA was not sequenced, gene expression not measured).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 831448, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-01T12:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2022-01-13', 'resultsFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Differentially Expressed Genes', 'timeFrame': 'Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)', 'description': 'Number of genes with a significant fold change before/after CBD in PBMCs (Peripheral Blood Mononuclear Cells) related to inflammation genes, calculated before and after CBD treatment (baseline and 1 month for 1 participant, 2 months for 2 participants).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Inflammation']}, 'referencesModule': {'references': [{'pmid': '38252549', 'type': 'DERIVED', 'citation': 'Marini S, Huber A, Cash MN, Salemi M, Cook RL, Borsa P, Mavian CN. Oral Cannabidiol Treatment Is Associated with an Anti-Inflammatory Gene Expression Signature in Myeloid Cells of People Living with HIV. Cannabis Cannabinoid Res. 2024 Aug;9(4):1028-1037. doi: 10.1089/can.2023.0139. Epub 2024 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://www.medrxiv.org/content/10.1101/2023.02.24.23285761v2', 'label': 'Preprint of the study on medRxiv'}]}, 'descriptionModule': {'briefSummary': 'People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.\n\nThe investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to take CBD and to participate in follow up for two months\n* Older than 21 and younger than 60\n* Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count \\<350cells/ml)\n\nExclusion Criteria:\n\n* Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis\n* All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count \\<350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)\n* UF(University of Florida)/Shands staff and students will not be considered for enrollment'}, 'identificationModule': {'nctId': 'NCT05209867', 'briefTitle': 'Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level', 'orgStudyIdInfo': {'id': 'IRB202101624 -A'}, 'secondaryIdInfos': [{'id': 'OCR41346', 'type': 'OTHER', 'domain': 'UF OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBD Intervention', 'description': 'Participants will self-administer CBD daily for 2 months.', 'interventionNames': ['Drug: CBD oil']}], 'interventions': [{'name': 'CBD oil', 'type': 'DRUG', 'otherNames': ['Cannabidiol'], 'description': '* Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc \\~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).\n* The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration', 'armGroupLabels': ['CBD Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Simone Marini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consortium for Medical Marijuana Clinical Outcomes Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}