Status:
RECRUITING
Cannabis, HIV and Mental Processing Systems
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Rutgers University
Conditions:
HIV Infections
Cannabis
Eligibility:
All Genders
18-70 years
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05430490
Start Date
March 23 2022
End Date
June 30 2026
Last Update
April 3 2025
Active Locations (2)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Rutgers University
Newark, New Jersey, United States, 08901