What this study is
This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.
What's being tested
- Multimodal, multi-parametric MRI
Intervention · OTHER
The investigators will use multimodal, multi-parametric sequences to investigate neuroinflammatory and neurodegenerative processes in vivo. Participants will be assessed three times over 2 years.
- Immune and cytokine profiling
Intervention · OTHER
Blood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.
- Neuropsychological testing
Intervention · BEHAVIORAL
Participants will have neuropsychological testing three times over 2 years.
Study details
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Cannabis · HIV · Inflammation · Cognition · Neuroimaging
- Enrolling
- 220 people
- Starts
- 2021-08-18
- Est. completion
- 2027-05-31
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 59 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Verified HIV status
- Current marijuana use (MJ+ groups only)
- No current marijuana use (MJ- groups only)
- Current engagement in HIV care (HIV+ participants only)
- Receipt of cART as first-line of treatment (HIV+ participants only)
- Stable cART regimen (HIV+ participants only)
- Undetectable HIV RNA viral load for >1 year (HIV+ participants only)
You can't join if
- Lifetime abuse for any illicit drug other than marijuana
- <9th grade education; illiteracy or lack of fluency in English
- History of moderate or severe head trauma
- Unstable or serious neurological disorders
- Severe mental illness
- Systemic autoimmune diseases
- Immunotherapy
- MRI contraindications
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBiotech Place
Winston-Salem, North Carolina, United States
- Christina S Meade, PhD · Contact336-716-0695Christina.Meade@wfusm.edu
- Sheri L Towe, PhD · Contact336-716-4331Sheri.Towe@wfusm.edu
- Christina S Meade, PhD · Principal investigator
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00098474
Principal investigator
Christina S Meade, PhD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.