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Recruiting NCT04810858

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

No phase Interventional Cannabis HIV Inflammation Cognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal, multi-parametric MRI, Immune and cytokine profiling, Neuropsychological testing.
Who it may be relevant to
Registry conditions: Cannabis, HIV, Inflammation, Cognition. Basic parameters: 25 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Multimodal, multi-parametric MRI
    The investigators will use multimodal, multi-parametric sequences to investigate neuroinflammatory and neurodegenerative processes in vivo. Participants will be assessed three times over 2 years.
  • Other Immune and cytokine profiling
    Blood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.
  • Behavioral Neuropsychological testing
    Participants will have neuropsychological testing three times over 2 years.

Primary outcome measures

  • Change in neurocognitive function as measured by neuropsychological battery [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in neuronal integrity as measured by N-acetyl aspartate (NAA) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in axonal loss and injury as measured by axonal diffusivity (AD) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in demyelination or dysmyelination as measured by radial diffusivity (RD) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in overall white matter integrity as measured by fractional anisotropy (FA) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in inflammation-related cellularity as measured by restricted fraction (RF) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in extracellular tissue edema as measured by non-restricted fraction (NF) [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume [Time frame: baseline, 1-year follow-up, and 2-year follow-up]
  • Change in white matter integrity as measured by white matter tract streamline count [Time frame: baseline, 1-year follow-up, and 2-year follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Biotech Place — Winston-Salem

Identifiers

NCT: NCT04810858 · IRB00098474 · R01DA052827

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗