Examining the effects of cannabis use on HIV and mental processing

Cannabis, HIV and Mental Processing Systems

This study looks at how regular cannabis use affects the immune system and brain function in people living with HIV and those without HIV.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Drugs / interventions: cART
• Locations: 2 sites (Saint Louis, Missouri and 1 other locations)
• Trial ID: NCT05430490 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between HIV infection and regular cannabis use by collecting extensive phenotype data from individuals living with HIV who are on combination anti-retroviral therapy, as well as HIV-negative controls. The study will assess immune activation, brain structure, and neuropsychological performance through various methods including MRI, blood draws, and psychological testing. By comparing data from regular cannabis users and non-users, the study aims to uncover critical insights into how cannabis affects immune function and cognitive performance in both HIV-positive and HIV-negative individuals.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 who are either living with HIV and on effective treatment or HIV-negative individuals, with a history of cannabis use.

Not a fit: Patients with a history of neurological disorders or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights that inform treatment strategies for individuals living with HIV, particularly regarding the impact of cannabis use.

How similar studies have performed: While there is ongoing research into the effects of cannabis on various health conditions, this specific approach examining the intersection of HIV and cannabis use is relatively novel.

Eligibility criteria

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.

Where this trial is running

Saint Louis, Missouri and 1 other locations

• Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
• Rutgers University — Newark, New Jersey, United States (Active_not_recruiting)

Study contacts

• Study coordinator: Linet Lopez

Conditions HIV Infections; Cannabis