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

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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

Tracking Information
First Submitted Date  ICMJE January 13, 2022
First Posted Date  ICMJE January 27, 2022
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE May 1, 2022
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HEMP: CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
Official Title  ICMJE CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammation
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: CBD Intervention
Participants will self-administer CBD daily for 2 months.
Intervention: Drug: CBD oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2022)		 7
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05209867
Other Study ID Numbers  ICMJE IRB202101624 -A
OCR41346 ( Other Identifier: UF OnCore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Consortium for Medical Marijuana Clinical Outcomes Research
Investigators  ICMJE
Principal Investigator: Simone Marini, PhD University of Florida
PRS Account University of Florida
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP