Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
NCT ID: NCT05209867
Last Updated: 2023-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
4 participants
INTERVENTIONAL
2022-05-01
2022-12-12
Brief Summary
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The 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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CBD Intervention
Participants will self-administer CBD daily for 2 months.
CBD 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).
* 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
Interventions
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CBD 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).
* 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Older than 21 and younger than 60
* Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count \<350cells/ml)
Exclusion Criteria
* 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)
* UF(University of Florida)/Shands staff and students will not be considered for enrollment
21 Years
60 Years
ALL
No
Sponsors
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Consortium for Medical Marijuana Clinical Outcomes Research
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Simone Marini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Preprint of the study on medRxiv
Other Identifiers
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OCR41346
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202101624 -A
Identifier Type: -
Identifier Source: org_study_id