About this trial

This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 21 to 70 years old

Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.

Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)

No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.

Disqualifiers

Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;

Significant cognitive impairment such as Dementia, including Alzheimer's disease

Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential

Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;

Trial design

Design model

Crossover

Treatments tested in this trial

THC
Drug
THC capsule
CBD
Drug
oral solution

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: THC first, then CBDExperimental treatment 2 interventions

Group B: CBD first, then THCActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PC1

A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 \[sCD163\], interferon gamma \[IFN-gamma\], interleukin 6 \[IL-6\], C-reactive protein \[CRP\], CC motif chemokine ligand 2 \[CCL2\], neopterin and soluble tumor necrosis factor - type II \[sTNFRII\]), all measured in picograms/milliliter

Time frame

Change from baseline to Week 2

2

PC1

A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 \[sCD163\], interferon gamma \[IFN-gamma\], interleukin 6 \[IL-6\], C-reactive protein \[CRP\], CC motif chemokine ligand 2 \[CCL2\], neopterin and soluble tumor necrosis factor - type II \[sTNFRII\]), measured in picograms/milliliter

Time frame

Change from Week 4 to Week 6

Secondary outcomes

1

blood-brain barrier (BBB)

BBB markers: claudin, suPAR, CSF/serum albumin ratio, MMP-2, occludin, all measured in picograms/milliliter

Time frame

Change from baseline to Week 2

2

blood-brain barrier (BBB)

BBB markers: claudin, suPAR, CSF/serum albumin ratio, MMP-2, occludin, measured in picograms/milliliter

Time frame

Change from Week 4 to Week 6

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts