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OpenTrials
Completed

NCT Number: NCT05209867

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

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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Key information

Conditions

Chronic Inflammation

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBD oil

Drug
  • 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

Primary outcomes

  1. Number of Differentially Expressed Genes

    Time frame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)

    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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Consortium for Medical Marijuana Clinical Outcomes Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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