Trial Outcomes & Findings for Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV (NCT NCT05209867)

NCT ID: NCT05209867

Last Updated: 2023-12-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2023-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	CBD Intervention Participants will self-administer CBD daily for 2 months. 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
Overall Study STARTED	4
Overall Study Completed 1 Month of Intervention	4
Overall Study Completed 2 Months of Intervention	3
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBD Intervention n=3 Participants Participants will self-administer CBD daily for 2 months. 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
10x single-cell gene expression	6553 Number of cells per patient STANDARD_DEVIATION 2111.5 • n=5 Participants
Procalcitonin	0.013 NG/ML STANDARD_DEVIATION 0.006 • n=5 Participants
Sedimentation Rate	19 MM/HR STANDARD_DEVIATION 11.3 • n=5 Participants
High-sensitivity CRP	4.7 MG/L STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

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

Population: Four individuals completed the assigned intervention. One individual completed one month only. Two individuals completed two months. A fourth individual completed two months but, after protocol and data review, the quality of the provided data was deemed not sufficient (single-cell RNA was not sequenced, gene expression not measured for that individual).

Outcome measures

Outcome measures
Measure	CBD Intervention n=3 Participants Participants will self-administer CBD daily for 2 months. 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
Number of Differentially Expressed Genes	8.3 Differentially expressed genes Standard Deviation 7

Adverse Events

CBD Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CBD Intervention n=4 participants at risk Participants will self-administer CBD daily for 2 months. 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
General disorders Neck pain	25.0% 1/4 • Number of events 1 • Adverse events were collected over the administration period (2 months)

Additional Information

Dr. Simone Marini

University of Florida

Phone: 3522948951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place