Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04810858

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cannabis Chemically-Induced Disorders Cognition HIV Inflammation Marijuana Abuse Mental Disorders Neuroimaging Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

25 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal, multi-parametric MRI

Other

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.

Immune and cytokine profiling

Other

Blood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.

neuropsychological testing

Behavioral

Participants will have neuropsychological testing three times over 2 years.

Primary outcomes

  1. Change in neurocognitive function as measured by neuropsychological battery

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    The neuropsychological testing battery assesses 7 cognitive domains with 3-4 tests per domain. Raw scores from each test will be converted to demographically adjusted standard scores, called T-scores using up-to-date US normative data. A T-score of 50 is considered the normative mean, and each 10-point deviation is equivalent to 1 standard deviation. The minimum possible T-score is 0 and the maximum is 100, with higher scores meaning better neurocognitive function. The average T-score for all tests in a domain will be the domain T-score, and the average of all domain T-scores will be the global T-score. T-scores will serve as the primary continuous measure because they capture the full range of cognitive function.

  2. Change in neuronal integrity as measured by N-acetyl aspartate (NAA)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    NAA will be measured using Echo-planar spectroscopic imaging. Lower NAA is associated with less neuronal integrity. NAA units of measure is parts per million.

  3. Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    GLX will be measured using Echo-planar spectroscopic imaging. Lower GLX is indicative of less neuronal-glial interactions. GLX units of measure is parts per million.

  4. Change in axonal loss and injury as measured by axonal diffusivity (AD)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    AD will be measured using diffusion-weighted imaging. Lower axonal diffusivity is associated with more axonal loss and injury. The unit of measure for AD is micrometer^2/millisecond.

  5. Change in demyelination or dysmyelination as measured by radial diffusivity (RD)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    RD will be measured using diffusion-weighted imaging. Higher radial diffusivity is associated with more demyelination and dysmyelination. The unit of measure for RD is micrometer^2/millisecond.

  6. Change in overall white matter integrity as measured by fractional anisotropy (FA)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    FA will be measured using diffusion-weighted imaging. Higher FA is associated with higher overall white matter integrity. FA is a scalar value between 0 and 1.

  7. Change in inflammation-related cellularity as measured by restricted fraction (RF)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    RF will be measured using diffusion-weighted imaging. Higher restricted fraction is associated with higher inflammation-related cellularity. The unit of measure for RF is micrometer^2/millisecond.

  8. Change in extracellular tissue edema as measured by non-restricted fraction (NF)

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    NF will be measured using diffusion-weighted imaging. Lower non-restricted fraction is associated with increased extracellular tissue edema. The unit of measure for NF is micrometer^2/millisecond.

  9. 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

    Cortical areas and thickness and cortical and subcortical volume will be measured using T1-weighted imaging. Lower gray matter is associated with decreased cognitive function and is a marker of neurodegenerative disease. Cortical area, thickness, and volume units of measure are in millimeter^2. Subcortical volume units of measure are in millimeter^3.

  10. 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

    White matter tract streamline count will be measured using diffusion-weighted imaging. Lower white matter tract streamline count is associated with lower white matter integrity. The unit of measure for white matter tract streamline count is the total number of streamlines within a white matter tract.

  11. Change in axonal damage was measured by neurofilament light (NfL) protein

    Time frame: baseline, 1-year follow-up, and 2-year follow-up

    NfL will be measured using blood serum and processed using an ultrasensitive immunoassay. Higher NfL is associated with more axonal damage. NfL protein units of measure are in picogram/milliliter^-1.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina S Meade, PhD

CONTACT

[email protected]

336-716-0695

Sheri L Towe, PhD

CONTACT

[email protected]

336-716-4331

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: CHI

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.