Chronic InflammationPhase 4NCT05209867

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

A Phase 4 study testing CBD oil in people with Chronic Inflammation, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 60 years
Conditions the study is for: Chronic Inflammation
What is being tested?: CBD oil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 1 May 2022to 12 Dec 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

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

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.

Conditions: Chronic Inflammation
Being tested: CBD oil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBD oilDrug
Also called Cannabidiol
- 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

Study groups in NCT05209867
Study group	Role	What they receive
CBD Intervention	Experimental	Participants will self-administer CBD daily for 2 months. Receives: Drug: CBD oil

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Differentially Expressed Genes
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).
Measured: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202212 Dec 2022

First posted27 Jan 2022
Study start1 May 2022
Primary completion12 Dec 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic InflammationStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05209867
Sponsor's protocol ID: IRB202101624 -A
Other IDs: OCR41346
Status last verified: Dec 2023
First submitted: 13 Jan 2022
Last updated: 28 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Marini S, Huber A, Cash MN, Salemi M, Cook RL, Borsa P, Mavian CN. Oral Cannabidiol Treatment Is Associated with an Anti-Inflammatory Gene Expression Signature in Myeloid Cells of People Living with HIV. Cannabis Cannabinoid Res. 2024 Aug;9(4):1028-1037. doi: 10.1089/can.2023.0139. Epub 2024 Jan 22.
PubMed 38252549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
ClinicalTrials.gov ID: NCT05209867
Acronym / sponsor ID: IRB202101624 -A
Conditions: Chronic Inflammation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Consortium for Medical Marijuana Clinical Outcomes Research
Study start: 1 May 2022 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 27 Jan 2022 (actual)
Results: Posted 28 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CBD Intervention	Experimental	Drug: CBD oilParticipants will self-administer CBD daily for 2 months.

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBD oilAlso: Cannabidiol* 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	Drug	CBD Intervention

Primary outcome

Number of Differentially Expressed Genes
Time frame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)
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).

Results and safety

Results posted to the registry on 28 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBD Intervention	4	4

Primary outcome: Number of Differentially Expressed Genes

Time frame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals). Mean (Standard Deviation). Unit: Differentially expressed genes

Measure	CBD Intervention n = 3
Value	8.3 (7)

Population analysed: 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).

Adverse events

Time frame: Adverse events were collected over the administration period (2 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBD Intervention	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): We processed data for individuals with different lengths of CBD exposure (2 months for two individuals; 1 month for one individual). The outcome is calculated at the single-cell level (i.e., the gene expression of each cell, from each sample, is measured), and not at the patient level. The low number of recruited patients makes impossible to draw conclusions at the patient level.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38252549Marini S, Huber A, Cash MN, Salemi M, Cook RL, Borsa P, Mavian CN. Oral Cannabidiol Treatment Is Associated with an Anti-Inflammatory Gene Expression Signature in Myeloid Cells of People Living with HIV. Cannabis Cannabinoid Res. 2024 Aug;9(4):1028-1037. doi: 10.1089/can.2023.0139. Epub 2024 Jan 22.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simone Marini, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CBD oil in people with Chronic Inflammation, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Differentially Expressed Genes (time frame: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05209867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.