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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Patricia Reid
314-747-1072
patriciareid@wustl.edu

More Details

NCT ID
NCT05430490
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Linet Lopez
314-747-6453
linetl@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.