Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury (CHI)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Inflammation; Neuroimaging; Cannabis; HIV; Cognition

Treatments: Other: Immune and cytokine profiling; Behavioral: Neuropsychological testing; Other: Multimodal, multi-parametric MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04810858

R01DA052827 (U.S. NIH Grant/Contract)

IRB00098474

Details and patient eligibility

About

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

Enrollment: 220 estimated patients

Sex: All

Ages: 25 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• verified HIV status
• Current marijuana use (MJ+ groups only)
• No current marijuana use (MJ- groups only)
• current engagement in HIV care (HIV+ participants only)
• receipt of cART as first-line of treatment (HIV+ participants only)
• stable cART regimen (HIV+ participants only)
• undetectable HIV RNA viral load for >1 year (HIV+ participants only)

Exclusion criteria

• Lifetime abuse for any illicit drug other than marijuana
• <9th grade education; illiteracy or lack of fluency in English
• history of moderate or severe head trauma
• unstable or serious neurological disorders
• severe mental illness
• systemic autoimmune diseases
• immunotherapy
• MRI contraindications

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

HIV+ marijuana user

Other group

Description:

Participants with HIV who report marijuana use

Treatment:

Other: Multimodal, multi-parametric MRI

Behavioral: Neuropsychological testing

Other: Immune and cytokine profiling

HIV+ non-drug user

Other group

Description:

Participants with HIV who report no drug use

Treatment:

Other: Multimodal, multi-parametric MRI

Behavioral: Neuropsychological testing

Other: Immune and cytokine profiling

HIV- marijuana user

Other group

Description:

Participants without HIV who report marijuana use

Treatment:

Other: Multimodal, multi-parametric MRI

Behavioral: Neuropsychological testing

Other: Immune and cytokine profiling

HIV- non-drug user

Other group

Description:

Participants without HIV who report no drug use

Treatment:

Other: Multimodal, multi-parametric MRI

Behavioral: Neuropsychological testing

Other: Immune and cytokine profiling