ClinicalTrials.gg
Enrolling by invitationNCT07222306CNSUpdated Oct 21, 2026

Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study

An observational study in PTSD, Suicidal Thoughts and Behaviors and PTSD Symptoms, sponsored by Wayne State University. Enrolling by invitation at 1 site in United States. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Wayne State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
19 Years to 69 Years
Sex
All
01

Study summary

This study will be the first to use brain imaging to explore how cannabis affects the brain and inflammation in U.S. military veterans with PTSD. It builds on an ongoing study testing different combinations of THC and CBD in 200 veterans. In this project, up to 100 veterans will complete brain scans before and after 12 weeks of cannabis administration to see how the brain changes over time. The scans will measure a marker sensitive to neuroinflammatory state, brain communication, and activity during thinking and emotion tasks. By linking these brain changes to improvements in PTSD symptoms, suicidal thoughts, and quality of life, this study may help identify which veterans benefit most from cannabis-based treatments and support more personalized care for PTSD.

Read the detailed description

This study, referred to here as the 'Neuroimaging Study,' is a supplement (add-on) to our ongoing VMR study (Wayne State Warriors Marijuana Clinical Research Program: Investigating the Impact of Cannabinoids on Veterans' Behavioral Health", PIs: Lundahl and Ledgerwood), which will be referred to as the 'Parent Study'. The Neuroimaging Study will be the first-ever neuroimaging study of cannabis treatment in US armed forces veterans with PTSD, or in any population. The Parent Study involves randomizing 200 veterans with PTSD into one of four different THC (∆9-tetrahydrocannabinol) : CBD (cannabidiol) dose conditions (High THC:High CBD; HighTHC:Low CBD; Low THC:High CBD, and Low THC:Low CBD) for a 12-week treatment phase. For the Neuroimaging Study, half of the 200 participants from the Parent Study (up to N=100; i.e., roughly 25 of the 50 participants in each dose condition) will additionally complete two brain imaging assessments: one before (i.e., 'baseline' scan) and one after the 12-week treatment period (i.e., 'post-treatment' scan). Primary outcomes include: A) neuroinflammatory state as measured via positron emission tomography (PET) imaging with the radiotracer, 1-(2-[+F]fluoroethyl)-L-tryptophan or [18F]FETrp; B) resting or 'basal' neural network communication as measured via functional magnetic resonance imaging (fMRI); and C) brain activation during well-validated inhibitory control (Go/No-Go), emotion regulation (Emotional Stroop), and reward processing (Duke Card Guessing) tasks as measured via fMRI. We will focus on brain regions that are consistently linked to both PTSD symptom severity and suicidal ideation, and that are densely populated with cannabinoid receptors (which are modulated by acute cannabis/cannabinoid administration). Further, the collection of whole-brain, multi-modal neuroimaging data (structural MRI, functional MRI, and PET imaging data) during the same session will allow us to explore the impact of cannabis/cannabinoid administration on the relationship between neuroinflammatory state and neural network activation and interactions throughout the brain, and link these brain metrics to clinical outcomes (e.g., reduction in suicidal ideation or PTSD/depression symptoms over time). This highly innovative approach will provide unprecedented insight into the neurobiological underpinnings of PTSD and suicidal ideation and the potential therapeutic effects of cannabis (and associated brain mechanisms) on these and other critical outcomes (e.g., quality of life, depressive symptoms). Findings from this Neuroimaging Study may also identify veterans who will benefit most from cannabinoid therapeutics and specific THC:CBD dose combinations therein, and thus, may inform a personalized medicine approach for veterans with PTSD in the future.

02

Conditions studied

  • PTSD
  • Suicidal Thoughts and Behaviors
  • PTSD Symptoms
  • Depressive Symptoms

Keywords

  • PTSD
  • Suicidal Thoughts
  • Cannabis
  • Brain Imaging
  • MRI
  • PET
  • Veterans
  • Depression
  • Cannabidiol
  • THC
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 371 observational studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Military veterans with PTSD

Eligibility criteria

Inclusion Criteria:

  • Eligible for, and provided written to participate in, the Parent Study (NCT06381180) and to be contacted regarding 'future research studies.'
  • Able/willing to provide written informed consent to participate in the Neuroimaging Study.

Exclusion Criteria (eligible if the subject does not meet both criteria):

  • for MRI scanning include, but are not limited to: as braces, pacemaker, implanted metal (self-report MR screening form and ferromagnetic detectors) or medical conditions that prevent comfortable MRI scanning procedures, e.g., inability to lay supine for 60 minutes, claustrophobia, or body weight > 275lbs.
  • Contraindications for PET [18F]FETrp imaging include, but are not limited to: chronic medical conditions that alter radiotracer pharmacokinetic properties, e.g, Diabetes I/II (or uncontrolled glucose levels [>200mg/dl non-fasting]), abnormal (\<18.5 or > 35kg/m2), diseases, or other chronic inflammatory conditions, or take medications (3+ days/week) that will alter radiotracer binding, e.g., glucose stabilizing medications, proton-pump inhibitors, or anti-inflammatory agents, or have medical conditions that prevent comfortable PET scanning procedures, e.g., inability to lay supine for \~75 minutes, tolerate a radial vein catheter and up to 35ml of whole blood drawn, or body weight > 275lbs.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • PET and/or MRI

    Positron emission tomography (PET) imaging with the radiotracer, 1-(2-\[+F\]fluoroethyl)-L-tryptophan or \[18F\]FETrp and/or magnetic resonance imaging (MRI)

    Drug: 1-(2-[+F]fluoroethyl)-L-tryptophan

Interventions

  • Drug1-(2-[+F]fluoroethyl)-L-tryptophan

    1-(2-\[+F\]fluoroethyl)-L-tryptophan tracer will be used during PET imaging

06

What researchers measure

Primary outcomes

  1. [18F]FETrp K-complex

    To quantify kynurenine uptake rate, a Patlak graphical analysis will be performed using the image-derived input function and the dynamic brain emission data. This method yields the unidirectional uptake rate constant, K-complex, in each brain region of interest. Outcome analyses will investigate associations with clinical symptoms and cognitive function at baseline, as longitudinal changes from baseline to follow-up with inter-group differences between dose conditions of particular interest.

    Time frame: Baseline and follow-up (at least 12 weeks after baseline)

  2. BOLD fMRI response

    BOLD fMRI response will be isolated by contrasting activation to the contrast Go/No-Go \> Rest for the inhibitory control task, iI \> cI for the emotion regulation task, and reward \> loss for the reward task.

    Time frame: Baseline and follow-up (at least 12 weeks after baseline)

07

Study locations

1 site
08

References and documents

Publications

  • Etkin A, Prater KE, Hoeft F, Menon V, Schatzberg AF. Failure of anterior cingulate activation and connectivity with the amygdala during implicit regulation of emotional processing in generalized anxiety disorder. Am J Psychiatry. 2010 May;167(5):545-54. doi: 10.1176/appi.ajp.2009.09070931. Epub 2010 Feb 1. PubMed 20123913 ↗
  • Fonzo GA, Etkin A, Zhang Y, Wu W, Cooper C, Chin-Fatt C, Jha MK, Trombello J, Deckersbach T, Adams P, McInnis M, McGrath PJ, Weissman MM, Fava M, Trivedi MH. Brain regulation of emotional conflict predicts antidepressant treatment response for depression. Nat Hum Behav. 2019 Dec;3(12):1319-1331. doi: 10.1038/s41562-019-0732-1. Epub 2019 Sep 23. PubMed 31548678 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Aug 2030, 55 months after the start.

Of 142 non-industry observational studies under Stress Disorders, Post-Traumatic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 59. This study's planned 55 months is above that.

Counting every sponsor, half of 149 studies reached it within 34 months; a quarter within 14 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2025
First posted
Oct 29, 2025
StartActual
Jan 1, 2026
Primary completionEst.
Aug 31, 2030
CompletionEst.
Aug 31, 2030
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07222306
Responsible party
Hilary Marusak (Associate Professor, Wayne State University) — Principal investigator
First posted
Oct 29, 2025
Start date
Jan 1, 2026
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Oct 21, 2026

Study contacts

Eric Woodcock
principal investigator · Wayne State University
Hilary Marusak, PhD
principal investigator · Wayne State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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