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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammation
• Intervention / Treatment: Drug: CBD oil

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBD Intervention; Participants will self-administer CBD daily for 2 months.

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; Other Names: Cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Consortium for Medical Marijuana Clinical Outcomes Research
• Investigators: Principal Investigator: Simone Marini, PhD, University of Florida

Publications and helpful links

Helpful Links

• Preprint of the study on medRxiv

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: IRB202101624 -A; OCR41346 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes