NCT05209867

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2022-01-27
• Last updated: 2023-12-28
• Results posted: 2023-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study