Cannabis, HIV and Mental Processing Systems
CHAMPS
1 other identifier
observational
320
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2022
CompletedFirst Submitted
Initial submission to the registry
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 3, 2025
March 1, 2025
4.3 years
April 25, 2022
March 31, 2025
Conditions
Outcome Measures
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.
Years 1-5
Secondary Outcomes (1)
Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.
Years 1-5
Study Arms (4)
HIV+ Cannabis User
Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis Non-User
Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV- Cannabis User
Persons without HIV who identify as using medical or recreational marijuana
HIV- Cannabis Non-User
Persons without HIV who identify as not using medical or recreational marijuana
Interventions
Multimodal neuroimaging on 3T Prisma Fit MRI
A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.
Laboratory reports (CMP, CBC, Lipids)
Life history, current behaviors, and substance use surveys
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
Eligibility Criteria
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.
You may qualify if:
- Participants must be 18-70 years old.
- 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).
- HIV- controls must have confirmed HIV- serostatus.
- Participants must complete at least 9 years of education.
- Participants must be able to provide informed consent.
- Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding.
- Participants should have no contraindications to an MRI scan.
- Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis .
You may not qualify if:
- History of neurological disorder (e.g., stroke, head injury with loss of consciousness for \>5 minutes, developmental learning disability, etc.).
- 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.
- 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).
- claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Rutgers Universitycollaborator
Study Sites (2)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Rutgers University
Newark, New Jersey, 08901, United States
Biospecimen
Blood and CSF
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2022
First Posted
June 24, 2022
Study Start
March 23, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share