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CompletedNCT05430490CHAMPSUpdated Apr 7, 2026

Cannabis, HIV and Mental Processing Systems

An observational study in HIV Infections and Cannabis, sponsored by Washington University School of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
276
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

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Conditions studied

  • HIV Infections
  • Cannabis
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 276 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A total of 160 PLWH (80 regular cannabis users and 80 non-users) and 160 demographically similar healthy HIV- controls (80 regular cannabis users and 80 non-users) may undergo multimodal neuroimaging, immunophenotyping (including blood and cerebrospinal fluid), and neuropsychological testing to address the specific aims.

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 .
  9. All inclusion criteria at PI discretion.

Exclusion criteria

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.
  8. all exclusion criteria at PI discretion.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
276 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HIV+ Cannabis User

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

    Procedure: MRI · Other: NeuroPsychological Testing · Procedure: Blood Draw · Other: Questionnaires · Procedure: Lumbar Puncture

  • HIV+ Cannabis Non-User

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

    Procedure: MRI · Other: NeuroPsychological Testing · Procedure: Blood Draw · Other: Questionnaires · Procedure: Lumbar Puncture

  • HIV- Cannabis User

    Persons without HIV who identify as using medical or recreational marijuana

    Procedure: MRI · Other: NeuroPsychological Testing · Procedure: Blood Draw · Other: Questionnaires · Procedure: Lumbar Puncture

  • HIV- Cannabis Non-User

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

    Procedure: MRI · Other: NeuroPsychological Testing · Procedure: Blood Draw · Other: Questionnaires · Procedure: Lumbar Puncture

Interventions

  • ProcedureMRI

    Multimodal neuroimaging on 3T Prisma Fit MRI

  • OtherNeuroPsychological 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.

  • ProcedureBlood Draw

    Laboratory reports (CMP, CBC, Lipids)

  • OtherQuestionnaires

    Life history, current behaviors, and substance use surveys

  • ProcedureLumbar Puncture

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

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What researchers measure

Primary outcomes

  1. Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.

    Validated plasma and cerebrospinal fluid (CSF) markers of immune health and inflammation (e.g., CD14, CD16, Neopterin, etc.), as well as novel neuroimaging methods of neuro-inflammation (e.g., DTI \& DBSI, 3T MRI) will be used to evaluate brain inflammation.

    Time frame: Years 1-5

Secondary outcomes

  1. Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.

    Neuropsychological assessment results will be normed and converted into Z scores for comparison with brain volumes calculated from the 3T.

    Time frame: Years 1-5

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Study locations

2 sites
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Rutgers University
    Newark, New Jersey 08901, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 30, 2025
  • Informed consent form · Nov 10, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05430490
Lead sponsor
Washington University School of Medicine
Collaborators
Rutgers University
Responsible party
Sponsor
First posted
Jun 24, 2022
Start date
Mar 23, 2022
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Apr 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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