Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04810858

Conditions

Cannabis

HIV

Inflammation

Cognition

Neuroimaging

Eligibility Criteria

Sex: All

Age: 25 - 59

Healthy Volunteers: Accepted

Interventions

Multimodal, multi-parametric MRI

Immune and cytokine profiling

Neuropsychological testing

Study Details

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.

Conditions

Cannabis

HIV

Inflammation

Cognition

Neuroimaging

Study ID

NCT04810858

Start date

Aug 18, 2021

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 59

Healthy Volunteers: Accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: HIV+ marijuana user

Participants with HIV who report marijuana use

other: HIV+ non-drug user

Participants with HIV who report no drug use

other: HIV- marijuana user

Participants without HIV who report marijuana use

other: HIV- non-drug user

Participants without HIV who report no drug use

Interventions

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.

Immune and cytokine profiling

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

Neuropsychological testing

Participants will have neuropsychological testing three times over 2 years.

Primary outcome measure

  • 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 ]
  • Change in axonal damage was measured by neurofilament light (NfL) protein [ Time Frame: baseline, 1-year follow-up, and 2-year follow-up ]

Central Contacts and Locations

Central contacts

Christina S Meade, PhD

336-716-0695Christina.Meade@wfusm.edu

Sheri L Towe, PhD

336-716-4331Sheri.Towe@wfusm.edu

Locations

Biotech Place

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Christina S Meade, PhD

336-716-0695Christina.Meade@wfusm.edu

Sheri L Towe, PhD

336-716-4331Sheri.Towe@wfusm.edu

Principal Investigator:

Christina S Meade, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-31.