Psilocybin Assisted Psychotherapy for TRD and SUD Trial

Bottom line: A Phase 1/2 trial is evaluating the effects of three psilocybin doses combined with psychotherapy on veterans and first responders with treatment-resistant depression and substance use disorder, but results are not yet available.

A small group of veterans and first responders with treatment-resistant depression and substance use disorder is being studied in a new trial that explores whether a single dose of psilocybin, when combined with psychotherapy, might help reduce symptoms.

What’s being tested

The trial is evaluating three different psilocybin doses—5mg, 10mg, and 25mg—administered in combination with psychotherapy. It’s aimed at people with treatment-resistant depression and co-occurring substance use disorder. Both conditions are common among veterans and first responders, who often deal with high levels of stress and trauma. The researchers are measuring changes in depression symptoms and substance use severity, and also looking at how psilocybin might affect brain activity.

The design at a glance

This is a Phase 1/2 clinical trial, currently in the “NOT_YET_RECRUITING” status, sponsored by Indiana University. Phase 1 trials typically examine safety and dosage, while Phase 2 looks at effectiveness and side effects in a larger group. The trial is comparing the effects of the three different psilocybin doses over six weeks. Participants will be monitored for changes in depression symptoms and substance use, and researchers will also look at the biological processes involved.

Why it matters

If this trial shows positive results, it could offer a new treatment approach for people who haven’t responded to other therapies for depression and substance use. These two conditions often go hand in hand, making them harder to treat. Veterans and first responders may face extra challenges, including stress and limited access to mental health care, so an intervention that addresses both issues at once could be valuable. The study could also help scientists understand how psychedelics affect the brain, possibly opening the door for more research.

What this does NOT mean yet

This trial is still in the early stages and has not yet enrolled participants. There are no results to report. Registration on ClinicalTrials.gov doesn’t mean the treatment is safe, effective, or approved by any regulatory body. Many trials don’t move past the early stages, and the outcomes of this one are still unknown. This registration should not be taken as a sign that the treatment is beneficial or a recommendation to seek it out.

How to follow it

For the latest updates, visit the trial’s page on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07499583. If results become available, they will be posted there. Tracking the trial’s progress can offer a glimpse into how psychedelic research is evolving and how it might be used in mental health care in the future.

Sources

https://clinicaltrials.gov/study/NCT07499583 | NCT07499583

Educational Disclaimer

This article is for informational and educational purposes only. It is not medical advice, mental health advice, diagnosis, treatment guidance, or a recommendation to use any substance, supplement, therapy, or protocol.

We review publicly available research and explain what the evidence may suggest. Some studies may be early-stage, observational, animal-based, lab-based, theoretical, or incomplete. Always consult a qualified professional before making health-related decisions.

Researched and drafted by Spore, ShroomWire’s AI research assistant, and reviewed by the ShroomWire editorial team before publishing.

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