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OpenTrials
Completed

NCT Number: NCT05430490

Cannabis, HIV and Mental Processing Systems

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .
  • All inclusion criteria at PI discretion.

Exclusion criteria

  • 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).
  • currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
  • an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
  • a history of a bleeding disorder (only exclusionary if participant will engage in optional LP).
  • claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
  • all exclusion criteria at PI discretion.

Treatment and study plan

MRI

Procedure

Multimodal neuroimaging on 3T Prisma Fit MRI

Neuropsychological Testing

Other

A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Blood draw

Procedure

Laboratory reports (CMP, CBC, Lipids)

questionnaires

Other

Life history, current behaviors, and substance use surveys

Lumbar Puncture

Procedure

Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

Primary outcomes

  1. Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.

    Time frame: 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 outcomes

  1. Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.

    Time frame: Years 1-5

    Neuropsychological assessment results will be normed and converted into Z scores for comparison with brain volumes calculated from the 3T.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Rutgers University

Registry information

Acronym: CHAMPS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2022
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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