PTSDCNSNCT07222306
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
An observational study of PTSD and Suicidal Thoughts and Behaviors, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- PTSD, Suicidal Thoughts and Behaviors, PTSD Symptoms
- What is being tested?
- 1-(2-[+F]fluoroethyl)-L-tryptophan
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Aug 2030
- Phase
- Observational
- 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 19 to 69 years
- All sexes
- Adult, Older adult
Study population: Military veterans with PTSD
Who may be able to join
- Eligible for, and provided written informed consent 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):
- Contraindications 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 BMI (<18.5 or > 35kg/m2), autoimmune 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.
Who cannot join
None listed.
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
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
Official title: Investigating the Therapeutic Impact of Cannabinoids on Neuroinflammation and Neurobiological Underpinnings of Suicide Ideation in Veterans With PTSD
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.
- Being tested
- 1-(2-[+F]fluoroethyl)-L-tryptophan
- Keywords
- PTSD, Suicidal Thoughts, Cannabis, Brain Imaging, MRI, PET, Veterans, Depression, Cannabidiol, THC
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicidal Ideation, Behavior, Depression, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-(2-[+F]fluoroethyl)-L-tryptophanDrug
1-(2-[+F]fluoroethyl)-L-tryptophan tracer will be used during PET imaging
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: 1-(2-[+F]fluoroethyl)-L-tryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: Baseline and follow-up (at least 12 weeks after baseline)
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.
Measured: Baseline and follow-up (at least 12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start1 Jan 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Barbara Ann Karmanos Cancer Institute
- Responsible party
- Principal investigator, Hilary Marusak, Wayne State University
- Investigators
- Eric Woodcock, Principal investigator, Wayne State UniversityHilary Marusak, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222306
- Sponsor's protocol ID
- IRB-24-09-7226
- Other IDs
- VMR2022-02
- Acronym
- CNS
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 20123913Fonzo 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Therapeutic Impact of Cannabinoids on Neuroinflammation and Neurobiological Underpinnings of Suicide Ideation in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT07222306
- Acronym / sponsor ID
- CNS / IRB-24-09-7226
- Keywords
- PTSD, Suicidal Thoughts, Cannabis, Brain Imaging, MRI, PET, Veterans, Depression
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Barbara Ann Karmanos Cancer Institute
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 29 Oct 2025 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET and/or MRI | – | Drug: 1-(2-[+F]fluoroethyl)-L-tryptophanPositron emission tomography (PET) imaging with the radiotracer, 1-(2-[+F]fluoroethyl)-L-tryptophan or [18F]FETrp and/or magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Military veterans with PTSD
Key inclusion criteria (5 listed)
- Eligible for, and provided written informed consent 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.
- Contraindications 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 BMI (<18.5 or > 35kg/m2), autoimmune 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 1-(2-[+F]fluoroethyl)-L-tryptophan1-(2-[+F]fluoroethyl)-L-tryptophan tracer will be used during PET imaging | Drug | PET and/or MRI |
Primary outcome
[18F]FETrp K-complex
Time frame: Baseline and follow-up (at least 12 weeks after baseline)
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.
BOLD fMRI response
Time frame: Baseline and follow-up (at least 12 weeks after baseline)
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.
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 21 Oct 2026.
- Background: PubMed 20123913Etkin 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.
- Background: PubMed 31548678Fonzo 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.
- Individual participant dataSharing planned: No
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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.
Eric Woodcock principal investigator
Wayne State University
Hilary Marusak, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Suicidal Thoughts and Behaviors, run by Wayne State University 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 5 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]FETrp K-complex (time frame: Baseline and follow-up (at least 12 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07222306, which also lists 2 linked publications.
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 21 Oct 2026.