NCT07222306

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
53mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Nov 2025Aug 2030

First Submitted

Initial submission to the registry

October 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

4.8 years

First QC Date

October 24, 2025

Last Update Submit

October 28, 2025

Conditions

Keywords

PTSDSuicidal ThoughtsCannabisBrain ImagingMRIPETVeteransDepressionCannabidiolTHC

Outcome Measures

Primary Outcomes (2)

  • [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.

    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.

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

Study Arms (1)

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

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

PET and/or MRI

Eligibility Criteria

Age19 Years - 69 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemales must not be pregnant
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Military veterans with PTSD

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

  • 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.

    PMID: 20123913BACKGROUND
  • 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.

    PMID: 31548678BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSuicidal IdeationBehaviorDepressionMarijuana Abuse

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Eric Woodcock

    Wayne State University

    PRINCIPAL INVESTIGATOR
  • Hilary Marusak, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2025

First Posted

October 29, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2030

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations