Cannabis, HIV and Mental Processing Systems (CHAMPS)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cannabis
• Intervention / Treatment: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture

• Study Type: Observational
• Enrollment (Actual): 276

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Newark, New Jersey, United States, 08901
      • Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• 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.

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV+ Cannabis User; Persons diagnosed with HIV who identify as using medical or recreational marijuana	Procedure: MRI; Multimodal neuroimaging on 3T Prisma Fit MRI; Other: 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.; Procedure: Blood Draw; Laboratory reports (CMP, CBC, Lipids); Other: Questionnaires; Life history, current behaviors, and substance use surveys; Procedure: Lumbar Puncture; 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	Procedure: MRI; Multimodal neuroimaging on 3T Prisma Fit MRI; Other: 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.; Procedure: Blood Draw; Laboratory reports (CMP, CBC, Lipids); Other: Questionnaires; Life history, current behaviors, and substance use surveys; Procedure: Lumbar Puncture; 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	Procedure: MRI; Multimodal neuroimaging on 3T Prisma Fit MRI; Other: 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.; Procedure: Blood Draw; Laboratory reports (CMP, CBC, Lipids); Other: Questionnaires; Life history, current behaviors, and substance use surveys; Procedure: Lumbar Puncture; 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	Procedure: MRI; Multimodal neuroimaging on 3T Prisma Fit MRI; Other: 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.; Procedure: Blood Draw; Laboratory reports (CMP, CBC, Lipids); Other: Questionnaires; Life history, current behaviors, and substance use surveys; Procedure: Lumbar Puncture; Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Years 1-5

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; HIV Infections; Marijuana Abuse; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Biopsy; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavioral Disciplines and Activities; Psychological Tests; Diagnostic Techniques, Neurological; Surveys and Questionnaires; Neuropsychological Tests; Spinal Puncture; Blood Specimen Collection
• Other Study ID Numbers: 202107149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No