Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
NCT ID: NCT04810858
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2021-08-18
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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HIV+ marijuana user
Participants with HIV who report marijuana use
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.
HIV+ non-drug user
Participants with HIV who report no drug use
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.
HIV- marijuana user
Participants without HIV who report marijuana use
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.
HIV- non-drug user
Participants without HIV who report no drug use
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* \<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
25 Years
59 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Christina S Meade, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Biotech Place
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00098474
Identifier Type: -
Identifier Source: org_study_id
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