Cannabis, HIV and Mental Processing Systems

Recruiting

• Conditions: Cannabis; HIV Infections
• Interventions: Procedure: MRI; Other: NeuroPsychological Testing; Procedure: Blood Draw; Other: Questionnaires; Procedure: Lumbar Puncture

• Registration Number: NCT05430490
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV- Cannabis Non-User	MRI	Persons without HIV who identify as not using medical or recreational marijuana
HIV- Cannabis Non-User	Lumbar Puncture	Persons without HIV who identify as not using medical or recreational marijuana
HIV+ Cannabis User	MRI	Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis User	Lumbar Puncture	Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis Non-User	MRI	Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV+ Cannabis Non-User	Blood Draw	Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV- Cannabis User	Questionnaires	Persons without HIV who identify as using medical or recreational marijuana
HIV- Cannabis Non-User	NeuroPsychological Testing	Persons without HIV who identify as not using medical or recreational marijuana
HIV+ Cannabis User	NeuroPsychological Testing	Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis User	Blood Draw	Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis Non-User	NeuroPsychological Testing	Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV+ Cannabis Non-User	Lumbar Puncture	Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV- Cannabis Non-User	Blood Draw	Persons without HIV who identify as not using medical or recreational marijuana
HIV+ Cannabis User	Questionnaires	Persons diagnosed with HIV who identify as using medical or recreational marijuana
HIV+ Cannabis Non-User	Questionnaires	Persons diagnosed with HIV who identify as not using medical or recreational marijuana
HIV- Cannabis User	NeuroPsychological Testing	Persons without HIV who identify as using medical or recreational marijuana
HIV- Cannabis User	Lumbar Puncture	Persons without HIV who identify as using medical or recreational marijuana
HIV- Cannabis Non-User	Questionnaires	Persons without HIV who identify as not using medical or recreational marijuana
HIV- Cannabis User	MRI	Persons without HIV who identify as using medical or recreational marijuana
HIV- Cannabis User	Blood Draw	Persons without HIV who identify as using medical or recreational marijuana

Primary Outcome Measures

Name	Time	Method
Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.	Years 1-5	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.

Secondary Outcome Measures

Name	Time	Method
Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.	Years 1-5	Neuropsychological assessment results will be normed and converted into Z scores for comparison with brain volumes calculated from the 3T.

Trial Locations

Locations (2)

Rutgers University; 🇺🇸 Newark, New Jersey, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States