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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05209867
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
Consortium for Medical Marijuana Clinical Outcomes Research
Information provided by (Responsible Party):
University of Florida

Study Description
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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
Chronic Inflammation Drug: CBD oil Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana
Drug Information available for: Cannabidiol

Arms and Interventions
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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 Name: Cannabidiol


Outcome Measures
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Primary Outcome Measures :
  1. Inflammation Reduction [ Time Frame: 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
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209867


Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Simone Marini, PhD    352-294-8951    simone.marini@ufl.edu   
Principal Investigator: Simone Marini, PhD         
Sponsors and Collaborators
University of Florida
Consortium for Medical Marijuana Clinical Outcomes Research
Investigators
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Principal Investigator: Simone Marini, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT05209867    
Other Study ID Numbers: IRB202101624 -A
OCR41346 ( Other Identifier: UF OnCore )
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022

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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:
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Inflammation
Pathologic Processes
Cannabidiol
Anticonvulsants