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| ID | Type | Description | Link |
|---|---|---|---|
| OCR41346 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| Consortium for Medical Marijuana Clinical Outcomes Research | OTHER |
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People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD Intervention | Experimental | Participants will self-administer CBD daily for 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD oil | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Differentially Expressed Genes | 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). | Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Marini, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38252549 | Derived | 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. |
| Label | URL |
|---|---|
| Preprint of the study on medRxiv | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Differentially Expressed Genes | 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). | 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). | Posted | Mean | Standard Deviation | Differentially expressed genes | Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals) |
|
Adverse events were collected over the administration period (2 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck pain | General disorders | Systematic Assessment | 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. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Simone Marini | University of Florida | 3522948951 | simone.marini@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2022 | Dec 1, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 10x single-cell gene expression | Mean | Standard Deviation | Number of cells per patient |
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| Procalcitonin | Mean | Standard Deviation | NG/ML |
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| Sedimentation Rate | Mean | Standard Deviation | MM/HR |
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| High-sensitivity CRP | Mean | Standard Deviation | MG/L |
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| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
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