Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-59
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
verified HIV status
Current marijuana use (MJ+ groups only)
No current marijuana use (MJ- groups only)
current engagement in HIV care (HIV+ participants only)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal, multi-parametric MRI
Other interventionThe 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
Other interventionBlood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.
Neuropsychological testing
BehavioralParticipants will have neuropsychological testing three times over 2 years.
Treatment groups
220 Participants
are divided into 4 treatment groupsGroup A: HIV+ marijuana userOther 3 interventions
Group B: HIV+ non-drug userOther 3 interventions
Group C: HIV- marijuana userOther 3 interventions
Group D: HIV- non-drug userOther 3 interventions
Trial outcomes
Primary outcomes
1
Change in neurocognitive function as measured by neuropsychological battery
The neuropsychological testing battery assesses 7 cognitive domains with 3-4 tests per domain. Raw scores from each test will be converted to demographically adjusted standard scores, called T-scores using up-to-date US normative data. A T-score of 50 is considered the normative mean, and each 10-point deviation is equivalent to 1 standard deviation. The minimum possible T-score is 0 and the maximum is 100, with higher scores meaning better neurocognitive function. The average T-score for all tests in a domain will be the domain T-score, and the average of all domain T-scores will be the global T-score. T-scores will serve as the primary continuous measure because they capture the full range of cognitive function.
Time frame
baseline, 1-year follow-up, and 2-year follow-up2
Change in neuronal integrity as measured by N-acetyl aspartate (NAA)
NAA will be measured using Echo-planar spectroscopic imaging. Lower NAA is associated with less neuronal integrity. NAA units of measure is parts per million.
Time frame
baseline, 1-year follow-up, and 2-year follow-up3
Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)
GLX will be measured using Echo-planar spectroscopic imaging. Lower GLX is indicative of less neuronal-glial interactions. GLX units of measure is parts per million.
Time frame
baseline, 1-year follow-up, and 2-year follow-up4
Change in axonal loss and injury as measured by axonal diffusivity (AD)
AD will be measured using diffusion-weighted imaging. Lower axonal diffusivity is associated with more axonal loss and injury. The unit of measure for AD is micrometer\^2/millisecond.
Time frame
baseline, 1-year follow-up, and 2-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov