ClinicalTrials.Veeva

Menu

Cannabis, HIV and Mental Processing Systems (CHAMPS)

The Washington University logo

The Washington University

Status

Enrolling

Conditions

Cannabis
HIV Infections

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05430490
202107149

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

320 participants in 4 patient groups

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

Trial contacts and locations

2

Loading...

Central trial contact

Elizabeth Westerhaus, MA; Linet Lopez

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems