Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
320 participants
OBSERVATIONAL
2022-03-23
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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HIV+ Cannabis User
Persons diagnosed with HIV who identify as using medical or recreational marijuana
MRI
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological Testing
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
Laboratory reports (CMP, CBC, Lipids)
Questionnaires
Life history, current behaviors, and substance use surveys
Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
HIV+ Cannabis Non-User
Persons diagnosed with HIV who identify as not using medical or recreational marijuana
MRI
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological Testing
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
Laboratory reports (CMP, CBC, Lipids)
Questionnaires
Life history, current behaviors, and substance use surveys
Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
HIV- Cannabis User
Persons without HIV who identify as using medical or recreational marijuana
MRI
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological Testing
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
Laboratory reports (CMP, CBC, Lipids)
Questionnaires
Life history, current behaviors, and substance use surveys
Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
HIV- Cannabis Non-User
Persons without HIV who identify as not using medical or recreational marijuana
MRI
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological Testing
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
Laboratory reports (CMP, CBC, Lipids)
Questionnaires
Life history, current behaviors, and substance use surveys
Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
Interventions
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MRI
Multimodal neuroimaging on 3T Prisma Fit MRI
NeuroPsychological Testing
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
Laboratory reports (CMP, CBC, Lipids)
Questionnaires
Life history, current behaviors, and substance use surveys
Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back
Eligibility Criteria
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Inclusion Criteria
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 .
Exclusion Criteria
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Rutgers University
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Rutgers University
Newark, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202107149
Identifier Type: -
Identifier Source: org_study_id
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