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

Primary Purpose

Chronic Inflammation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CBD oil
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammation

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBD Intervention

Arm Description

Participants will self-administer CBD daily for 2 months.

Outcomes

Primary Outcome Measures

Inflammation Reduction
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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
September 15, 2022
Sponsor
University of Florida
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research
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1. Study Identification

Unique Protocol Identification Number
NCT05209867
Brief Title
HEMP: CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
Acronym
cannabis
Official Title
CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBD Intervention
Arm Type
Experimental
Arm Description
Participants will self-administer CBD daily for 2 months.
Intervention Type
Drug
Intervention Name(s)
CBD oil
Other Intervention Name(s)
Cannabidiol
Intervention Description
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
Primary Outcome Measure Information:
Title
Inflammation Reduction
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Marini, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Marini, PhD
Phone
352-294-8951
Email
simone.marini@ufl.edu
First Name & Middle Initial & Last Name & Degree
Simone Marini, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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