Clinical trial NCT04810858: Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
Official title: Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis
HIV
Inflammation
Cognition
Neuroimaging
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-23
Enrollment: 220
Sex: ALL
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of 4 study groups: HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana users, and HIV- non-drug user
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in neurocognitive function as measured by neuropsychological battery
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in neuronal integrity as measured by N-acetyl aspartate (NAA)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in axonal loss and injury as measured by axonal diffusivity (AD)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in demyelination or dysmyelination as measured by radial diffusivity (RD)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in overall white matter integrity as measured by fractional anisotropy (FA)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in inflammation-related cellularity as measured by restricted fraction (RF)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in extracellular tissue edema as measured by non-restricted fraction (NF)
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in white matter integrity as measured by white matter tract streamline count
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
measure: Change in axonal damage was measured by neurofilament light (NfL) protein
timeFrame: baseline, 1-year follow-up, and 2-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Biotech Place
state: North Carolina
Study officials:
affiliation: Duke University
name: Christina S Meade, PhD
role: PRINCIPAL_INVESTIGATOR
References: