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

NCT ID: NCT04810858

Last Updated: 2025-07-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis HIV Inflammation Cognition Neuroimaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of 4 study groups: HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana users, and HIV- non-drug user
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HIV+ marijuana user

Participants with HIV who report marijuana use

Group Type OTHER

Multimodal, multi-parametric MRI

Intervention Type 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

Intervention Type OTHER

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

Neuropsychological testing

Intervention Type BEHAVIORAL

Participants will have neuropsychological testing three times over 2 years.

HIV+ non-drug user

Participants with HIV who report no drug use

Group Type OTHER

Multimodal, multi-parametric MRI

Intervention Type 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

Intervention Type OTHER

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

Neuropsychological testing

Intervention Type BEHAVIORAL

Participants will have neuropsychological testing three times over 2 years.

HIV- marijuana user

Participants without HIV who report marijuana use

Group Type OTHER

Multimodal, multi-parametric MRI

Intervention Type 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

Intervention Type OTHER

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

Neuropsychological testing

Intervention Type BEHAVIORAL

Participants will have neuropsychological testing three times over 2 years.

HIV- non-drug user

Participants without HIV who report no drug use

Group Type OTHER

Multimodal, multi-parametric MRI

Intervention Type 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

Intervention Type OTHER

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

Neuropsychological testing

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Immune and cytokine profiling

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

Intervention Type OTHER

Neuropsychological testing

Participants will have neuropsychological testing three times over 2 years.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina S Meade, PhD

Role: CONTACT

336-716-0695

Sheri L Towe, PhD

Role: CONTACT

336-716-4331

Facility Contacts

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Christina S Meade, PhD

Role: primary

336-716-0695

Sheri L Towe, PhD

Role: backup

336-716-4331

Other Identifiers

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R01DA052827

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00098474

Identifier Type: -

Identifier Source: org_study_id

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