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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT05209867
Collaborator
Consortium for Medical Marijuana Clinical Outcomes Research (Other)
7
Enrollment
1
Location
1
Arm
21.1
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CBD oil
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Inflammation Reduction [2 months]

      Fold change before/after CBD in PBMC(Peripheral Blood Mononuclear Cells) cells for MAPK(Mitogen-Activated Protein Kinase) related inflammation genes by measure the change in the expression of genes related to inflammation in cells from the patient's blood before and after administering CBD.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida
    • Consortium for Medical Marijuana Clinical Outcomes Research

    Investigators

    • Principal Investigator: Simone Marini, PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT05209867
    Other Study ID Numbers:
    • IRB202101624 -A
    • OCR41346
    First Posted:
    Jan 27, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    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
    Additional relevant MeSH terms:
    Inflammation
    Cannabidiol

    Study Results

    No Results Posted as of Jul 7, 2022