CannabisCHINCT04810858
Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
A study testing Multimodal, multi-parametric MRI, Immune and cytokine profiling and Neuropsychological testing in people with Cannabis and HIV, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, HIV, Inflammation
- What is being tested?
- Multimodal, multi-parametric MRI, Immune and cytokine profiling and Neuropsychological testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biotech Place
Winston-Salem, North Carolina, 27101
Christina S Meade, PhD, 336-716-0695, Christina.Meade@wfusm.edu
Sheri L Towe, PhD, 336-716-4331, Sheri.Towe@wfusm.edu
About this study
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.
- Conditions
- Cannabis, HIV, Inflammation, Cognition, Neuroimaging
- Being tested
- Multimodal, multi-parametric MRI, Immune and cytokine profiling, Neuropsychological testing
- Medical subject headings
- Marijuana Abuse, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal, multi-parametric MRIOther
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 profilingOther
Blood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.
Neuropsychological testingBehavioural
Participants will have neuropsychological testing three times over 2 years.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ marijuana user | Other | Participants with HIV who report marijuana use Receives: Other: Multimodal, multi-parametric MRI; Other: Immune and cytokine profiling; Behavioral: Neuropsychological testing |
| HIV+ non-drug user | Other | Participants with HIV who report no drug use Receives: Other: Multimodal, multi-parametric MRI; Other: Immune and cytokine profiling; Behavioral: Neuropsychological testing |
| HIV- marijuana user | Other | Participants without HIV who report marijuana use Receives: Other: Multimodal, multi-parametric MRI; Other: Immune and cytokine profiling; Behavioral: Neuropsychological testing |
| HIV- non-drug user | Other | Participants without HIV who report no drug use Receives: Other: Multimodal, multi-parametric MRI; Other: Immune and cytokine profiling; Behavioral: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1-year follow-up, and 2-year follow-up
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.
Measured: baseline, 1-year follow-up, and 2-year follow-up
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.
Measured: baseline, 1-year follow-up, and 2-year follow-up
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.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in demyelination or dysmyelination as measured by radial diffusivity (RD)
RD will be measured using diffusion-weighted imaging. Higher radial diffusivity is associated with more demyelination and dysmyelination. The unit of measure for RD is micrometer^2/millisecond.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in overall white matter integrity as measured by fractional anisotropy (FA)
FA will be measured using diffusion-weighted imaging. Higher FA is associated with higher overall white matter integrity. FA is a scalar value between 0 and 1.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in inflammation-related cellularity as measured by restricted fraction (RF)
RF will be measured using diffusion-weighted imaging. Higher restricted fraction is associated with higher inflammation-related cellularity. The unit of measure for RF is micrometer^2/millisecond.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in extracellular tissue edema as measured by non-restricted fraction (NF)
NF will be measured using diffusion-weighted imaging. Lower non-restricted fraction is associated with increased extracellular tissue edema. The unit of measure for NF is micrometer^2/millisecond.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume
Cortical areas and thickness and cortical and subcortical volume will be measured using T1-weighted imaging. Lower gray matter is associated with decreased cognitive function and is a marker of neurodegenerative disease. Cortical area, thickness, and volume units of measure are in millimeter^2. Subcortical volume units of measure are in millimeter^3.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in white matter integrity as measured by white matter tract streamline count
White matter tract streamline count will be measured using diffusion-weighted imaging. Lower white matter tract streamline count is associated with lower white matter integrity. The unit of measure for white matter tract streamline count is the total number of streamlines within a white matter tract.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Change in axonal damage was measured by neurofilament light (NfL) protein
NfL will be measured using blood serum and processed using an ultrasensitive immunoassay. Higher NfL is associated with more axonal damage. NfL protein units of measure are in picogram/milliliter^-1.
Measured: baseline, 1-year follow-up, and 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start18 Aug 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of 4 study groups: HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana users, and HIV- non-drug user
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christina S Meade, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810858
- Sponsor's protocol ID
- IRB00098474
- Other IDs
- R01DA052827
- Acronym
- CHI
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any guidelines, protocols, and operating procedures generated will be made freely available. The investigators will make the data and associated documentation available to users under a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury
- ClinicalTrials.gov ID
- NCT04810858
- Acronym / sponsor ID
- CHI / IRB00098474
- Conditions
- Cannabis, HIV, Inflammation, Cognition, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to one of 4 study groups: HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana users, and HIV- non-drug user
| Arm | Type | Receives |
|---|---|---|
| HIV+ marijuana user | Other | Other: Multimodal, multi-parametric MRI, Other: Immune and cytokine profiling, Behavioral: Neuropsychological testingParticipants with HIV who report marijuana use |
| HIV+ non-drug user | Other | Other: Multimodal, multi-parametric MRI, Other: Immune and cytokine profiling, Behavioral: Neuropsychological testingParticipants with HIV who report no drug use |
| HIV- marijuana user | Other | Other: Multimodal, multi-parametric MRI, Other: Immune and cytokine profiling, Behavioral: Neuropsychological testingParticipants without HIV who report marijuana use |
| HIV- non-drug user | Other | Other: Multimodal, multi-parametric MRI, Other: Immune and cytokine profiling, Behavioral: Neuropsychological testingParticipants without HIV who report no drug use |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal, multi-parametric MRIThe investigators will use multimodal, multi-parametric sequences to investigate neuroinflammatory and neurodegenerative processes in vivo. Participants will be assessed three times over 2 years. | Other | HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana user, HIV- non-drug user |
| Immune and cytokine profilingBlood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years. | Other | HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana user, HIV- non-drug user |
| Neuropsychological testingParticipants will have neuropsychological testing three times over 2 years. | Behavioural | HIV+ marijuana user, HIV+ non-drug user, HIV- marijuana user, HIV- non-drug user |
Primary outcome
Change in neurocognitive function as measured by neuropsychological battery
Time frame: baseline, 1-year follow-up, and 2-year follow-up
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.
Change in neuronal integrity as measured by N-acetyl aspartate (NAA)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
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.
Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
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.
Change in axonal loss and injury as measured by axonal diffusivity (AD)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
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.
Change in demyelination or dysmyelination as measured by radial diffusivity (RD)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
RD will be measured using diffusion-weighted imaging. Higher radial diffusivity is associated with more demyelination and dysmyelination. The unit of measure for RD is micrometer^2/millisecond.
Change in overall white matter integrity as measured by fractional anisotropy (FA)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
FA will be measured using diffusion-weighted imaging. Higher FA is associated with higher overall white matter integrity. FA is a scalar value between 0 and 1.
Change in inflammation-related cellularity as measured by restricted fraction (RF)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
RF will be measured using diffusion-weighted imaging. Higher restricted fraction is associated with higher inflammation-related cellularity. The unit of measure for RF is micrometer^2/millisecond.
Change in extracellular tissue edema as measured by non-restricted fraction (NF)
Time frame: baseline, 1-year follow-up, and 2-year follow-up
NF will be measured using diffusion-weighted imaging. Lower non-restricted fraction is associated with increased extracellular tissue edema. The unit of measure for NF is micrometer^2/millisecond.
Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume
Time frame: baseline, 1-year follow-up, and 2-year follow-up
Cortical areas and thickness and cortical and subcortical volume will be measured using T1-weighted imaging. Lower gray matter is associated with decreased cognitive function and is a marker of neurodegenerative disease. Cortical area, thickness, and volume units of measure are in millimeter^2. Subcortical volume units of measure are in millimeter^3.
Change in white matter integrity as measured by white matter tract streamline count
Time frame: baseline, 1-year follow-up, and 2-year follow-up
White matter tract streamline count will be measured using diffusion-weighted imaging. Lower white matter tract streamline count is associated with lower white matter integrity. The unit of measure for white matter tract streamline count is the total number of streamlines within a white matter tract.
Change in axonal damage was measured by neurofilament light (NfL) protein
Time frame: baseline, 1-year follow-up, and 2-year follow-up
NfL will be measured using blood serum and processed using an ultrasensitive immunoassay. Higher NfL is associated with more axonal damage. NfL protein units of measure are in picogram/milliliter^-1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. Any guidelines, protocols, and operating procedures generated will be made freely available. The investigators will make the data and associated documentation available to users under a data-sharing agreement.
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina S Meade, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal, multi-parametric MRI, Immune and cytokine profiling and Neuropsychological testing in people with Cannabis and HIV, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina S Meade, PhD (336-716-0695, Christina.Meade@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurocognitive function as measured by neuropsychological battery (time frame: baseline, 1-year follow-up, and 2-year follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.