Cannabis, HIV and Mental Processing Systems

NCT ID: NCT05430490

Last Updated: 2025-04-03

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

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-23

Study Completion Date

2026-06-30

Brief Summary

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This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.

Detailed Description

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Conditions

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HIV Infections Cannabis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV+ Cannabis User

Persons diagnosed with HIV who identify as using medical or recreational marijuana

MRI

Intervention Type PROCEDURE

Multimodal neuroimaging on 3T Prisma Fit MRI

NeuroPsychological Testing

Intervention Type OTHER

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Blood Draw

Intervention Type PROCEDURE

Laboratory reports (CMP, CBC, Lipids)

Questionnaires

Intervention Type OTHER

Life history, current behaviors, and substance use surveys

Lumbar Puncture

Intervention Type PROCEDURE

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

HIV+ Cannabis Non-User

Persons diagnosed with HIV who identify as not using medical or recreational marijuana

MRI

Intervention Type PROCEDURE

Multimodal neuroimaging on 3T Prisma Fit MRI

NeuroPsychological Testing

Intervention Type OTHER

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Blood Draw

Intervention Type PROCEDURE

Laboratory reports (CMP, CBC, Lipids)

Questionnaires

Intervention Type OTHER

Life history, current behaviors, and substance use surveys

Lumbar Puncture

Intervention Type PROCEDURE

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

HIV- Cannabis User

Persons without HIV who identify as using medical or recreational marijuana

MRI

Intervention Type PROCEDURE

Multimodal neuroimaging on 3T Prisma Fit MRI

NeuroPsychological Testing

Intervention Type OTHER

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Blood Draw

Intervention Type PROCEDURE

Laboratory reports (CMP, CBC, Lipids)

Questionnaires

Intervention Type OTHER

Life history, current behaviors, and substance use surveys

Lumbar Puncture

Intervention Type PROCEDURE

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

HIV- Cannabis Non-User

Persons without HIV who identify as not using medical or recreational marijuana

MRI

Intervention Type PROCEDURE

Multimodal neuroimaging on 3T Prisma Fit MRI

NeuroPsychological Testing

Intervention Type OTHER

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Blood Draw

Intervention Type PROCEDURE

Laboratory reports (CMP, CBC, Lipids)

Questionnaires

Intervention Type OTHER

Life history, current behaviors, and substance use surveys

Lumbar Puncture

Intervention Type PROCEDURE

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

Interventions

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MRI

Multimodal neuroimaging on 3T Prisma Fit MRI

Intervention Type PROCEDURE

NeuroPsychological Testing

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Intervention Type OTHER

Blood Draw

Laboratory reports (CMP, CBC, Lipids)

Intervention Type PROCEDURE

Questionnaires

Life history, current behaviors, and substance use surveys

Intervention Type OTHER

Lumbar Puncture

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Participants must be 18-70 years old.
2. PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (\< 200 copies/mL).
3. HIV- controls must have confirmed HIV- serostatus.
4. Participants must complete at least 9 years of education.
5. Participants must be able to provide informed consent.
6. Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding.
7. Participants should have no contraindications to an MRI scan.
8. Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis .

Exclusion Criteria

1. History of neurological disorder (e.g., stroke, head injury with loss of consciousness for \>5 minutes, developmental learning disability, etc.).
2. Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed.
3. Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD \> 1 year before the time of study enrolment will be allowed).
4. currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
5. an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
6. a history of a bleeding disorder (only exclusionary if participant will engage in optional LP).
7. claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers University

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Rutgers University

Newark, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Linet Lopez

Role: CONTACT

314-747-6453

Elizabeth Westerhaus, MA

Role: CONTACT

3147471125

Facility Contacts

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Patricia Reid

Role: primary

314-747-1072

Other Identifiers

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202107149

Identifier Type: -

Identifier Source: org_study_id

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