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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04810858
Status
Recruiting

Conditions

  • Cannabis
  • Cognition
  • HIV
  • Inflammation
  • Neuroimaging

Eligibility Criteria

Sex
ALL
Age
25 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 18, 2021
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

Change in neurocognitive function as measured by neuropsychological battery [ Time Frame: baseline, 1-year follow-up, and 2-year follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Biotech PlaceWinston-SalemNorth Carolina27101
Christina S Meade, PhD
336-716-0695
Sheri L Towe, PhD
336-716-4331
Christina S Meade, PhD (PRINCIPAL_INVESTIGATOR)

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