NCT05430490Completed
Cannabis, HIV and Mental Processing Systems
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 276 (actual)
- First submitted
- 25 Apr 2022
- Start date
- Mar 2022
- Primary completion date
- Mar 2026
- Lead sponsor
- Washington University School of Medicine
- Diseases
- HIV
- NCT number
- NCT05430490
What you commit to
- Study type: Observational
- Participants enrolled: 276
- From Mar 2022 to the primary completion date, Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- 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).
Other
- currently prescribed anti-coagulants (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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers University Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.