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

October 28, 2025 updated by: Hilary Marusak, Wayne State University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Tolan Park Medical Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Military veterans with PTSD

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
1-(2-[+F]fluoroethyl)-L-tryptophan tracer will be used during PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[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.
Baseline and follow-up (at least 12 weeks after baseline)
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.
Baseline and follow-up (at least 12 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Barbara Ann Karmanos Cancer Institute

Investigators

  • Principal Investigator: Hilary Marusak, PhD, Wayne State University
  • Principal Investigator: Eric Woodcock, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2030

Study Registration Dates

First Submitted

October 24, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Actual)

October 29, 2025

Study Record Updates

Last Update Posted (Actual)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-24-09-7226
  • VMR2022-02 (Other Grant/Funding Number: State of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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