Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

Chronic Inflammation Clinical Trial

Official title:

CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209867
• Other study ID #: IRB202101624 -A
• Secondary ID: OCR41346
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Willingness to take CBD and to participate in follow up for two months
• Older than 21 and younger than 60
• Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count <350cells/ml)

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Chronic Inflammation
• Inflammation

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Consortium for Medical Marijuana Clinical Outcomes Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)

External Links

•   Preprint of the study on medRxiv