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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Page 1 of 1 (2 locations)

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

2

Rutgers University

Newark, New Jersey, United States, 08901