COMPASS Pathways has named Fluence one of its official training providers for COMP360, their psilocybin treatment for treatment-resistant depression. This partnership is a major step toward making evidence-based psilocybin therapy training available the moment COMP360 reaches clinics. Our Co-Founder and CEO, Elizabeth Nielson, digs into what this partnership means for practitioners and for the field in this month's Founders' Corner.
Founder’s Corner: What the FDA's 2026 Final Psychedelic Drug Guidance Means for Clinical Trial Training
Pre-register for the Post-Approval COMP360 Psilocybin Certificate Program Now
Join our Webinar, Getting Ready for Psychedelic Therapy: A Therapist's Guide to What's Next
Read our Press Release
Learn More About Compass Pathways and COMP360
Happy reading!
In 2019 as I sat with participants in Compass Pathways' Phase 2b study of psilocybin (COMP360) for treatment-resistant depression I knew something pivotal was happening. Everything about that work, the dosing procedures, the therapist manual, even the language we used to describe what was happening in the room, was part of what was being studied for continued refinement and improvement, all with an intense focus on how the treatment could eventually be made available to patients broadly through the healthcare system. There was still a great amount of uncertainty as to the future of the treatment, but what we did know was that the people in front of us were suffering, and that the small, careful steps we were taking mattered enormously to whether and how this treatment would ever reach people beyond that room.
I've been thinking about that early work today, because Fluence is announcing something I have been anticipating for years. We are partnering directly with Compass Pathways to build a training program for post-approval work with COMP360, in the event it does receive FDA approval and becomes a prescription medication available to patients. I am deeply grateful for this opportunity, and genuinely excited about what it represents, both for Fluence and for the clinicians we have trained who have been waiting for a moment like this one.
A grant, and a responsibility
Longtime readers may remember that back in the spring, Compass opened a training partnership grant program to identify organizations equipped to build provider training for COMP360 ahead of potential approval. As a recipient of that grant, Fluence will work closely with Compass Pathways to make sure the program we build aligns with their expectations and with the standard of quality treatment established across their clinical research trials. The program has to reflect years of accumulated knowledge about how COMP360 is actually administered, monitored, and supported, translated faithfully into a format that clinicians outside the trial environment can learn from.
As an organization, we bring two things to this work: a history of training clinicians for work with psychedelics within their professional scope of practice, and an established flow of research partnerships through which we have designed and implemented psychedelic therapist training that is repeatable, scalable, and rigorous enough to meet the demands of the regulated clinical trials environment. For me personally, this program is an exciting opportunity to bring those two streams of our work together. For the first time, we can anticipate offering training in the specific use of an FDA-approved psychedelic for a clinical mental health indication in the marketplace, beyond clinical trials.
Two streams, finally brought together
It's worth pausing to look at how we got here, because the path was not obvious when we started walking it.
Fluence began as a series of workshops to educate clinicians on how psychedelic therapy worked, what kind of research was being conducted with psychedelics, and how to build a basic framework for talking with clients who showed interest in taking psychedelics themselves. In those early days, it was nearly impossible for a licensed mental health care provider to get any real education about psychedelic therapy unless they were working on a research trial, and those opportunities were few and far between. Over the years that work grew into an established continuing education program that has seen thousands of therapists. However, with the most promising psychedelic treatments still confined to the research environment, licensed clinicians working in community practice environments are limited in what they can get trained to work with and offer to their patients.
Specifically, that means very few licensed psychotherapists have had the opportunity to work directly with psychedelics themselves: to provide the sessions, and to see clients all the way through the process, from preparation, through dosing, to integration. Closing that particular gap for at least for one specific FDA-approved treatment is exactly what this new program is designed to do.
A long time in the making
The effort to build the case for psychedelic therapy has been years in the making. Depending on where you start counting, it is easily measured in decades rather than years: it has been close to a century since Kurt Beringer conducted some of the earliest systematic medical research on mescaline in 1927, and nearly 90 years since Albert Hofmann synthesized LSD in 1938. For some, it may seem that it's already taken way too long to arrive at this juncture. I recognize that fully. People are suffering from debilitating mental health conditions right now, and may stand to benefit from this treatment.
I also recognize that, especially in the last five to seven years, a large network of researchers, biotech companies, academic institutes, training programs, and thousands of professionals is working diligently and as quickly as can be done safely to bring psychedelic therapies to the people who need them through the regulated health care system. What may seem like an interminable wait to those in need can also feel like an overwhelming rush to those of us designing projects, seeking approvals, organizing funding, building infrastructure, and gathering, analyzing, and submitting data.
To the clinicians who have been waiting for this moment for years: I sincerely appreciate your patience. We hear from many of you periodically, and we know a good number of you are anxiously awaiting the availability of this kind of therapy, so that you will have better tools in your toolbox to help the patients you most care about and have dedicated your careers to helping.
What comes next
Now that this partnership has been announced, I will be providing updates regularly, here in the Founder's Corner and on our social media accounts, to help guide your decision making and prepare you for the next steps. This is one part of a much larger effort toward building a professional field with evidence based treatments and rigorous training programs. COMP360 is still moving through the FDA approval process, and there is real work ahead before any of this reaches a clinician's office. But I wanted you to hear directly from me, on the day this is announced, why this moment matters to me and to Fluence, and why I believe it is worth your attention too.
Thanks for reading,
Co-Founder & CEO
Pre-registration for Fluence's Post-Approval COMP360 Psilocybin Certificate Program is open today, so you can secure your spot before the program launches. Reserving your seat means you'll be first in line for enrollment, certification, and every update as the curriculum comes together.
Two tracks are in development: one for licensed clinicians of all license types who will deliver COMP360 sessions directly, and one for non-licensed team members who support treatment delivery, including front desk staff, clinic owners, and other operational roles.
Pre-registration requires a $500 deposit per person to hold your seat.
Fluence helps clinics and group practices build and maintain a consistently trained clinical team as your services evolve, without coordinating it alone. Bulk enrollment support pairs with Fluence Sync, our proprietary platform for tracking trainee progress, readiness, and audit-ready reporting. It's how we help you inform your protocols and build consistent clinical competency across your team with high-quality, practitioner-led training. For detailed information on how Fluence can support your clinic or group practice as you integrate COMP360 into your business, schedule a consultation here.
Free Webinar | Tuesday, September 30 | 12:00 PM ET
As psychedelic therapies move closer to FDA approval, clinicians across the country are asking the same questions: what comes next, and how do I prepare? Join Fluence and the Trauma Therapist Network for a practical session on the post-approval training landscape, covering:
What clinical training will look like once psychedelic therapies gain approval
How credentialing is likely to work for clinicians entering the field
Key decisions to weigh for your own practice as the field develops
We'll also explore why a background in trauma therapy translates so naturally into psychedelic therapy work, and what that means for clinicians considering this path. Whether you're just starting to explore the field or actively planning your next professional steps, this session will give you a clear and grounded sense of where things stand and where they're headed.
Fluence co-founder and CEO Elizabeth Nielson, PhD will co-host the conversation with Laura Reagan, LCSW-C, host of the Therapy Chat Podcast and founder of the Trauma Therapist Network.
New certificate program will prepare clinicians to support patients receiving COMP360 psilocybin treatment, if approved by the FDA.
COMP360 is COMPASS Pathways' investigational, synthetic formulation of psilocybin, being developed for treatment-resistant depression (TRD). Two Phase 3 trials have now met their primary endpoint, COMP360 holds FDA Breakthrough Therapy Designation, and COMPASS Pathways expects to complete its New Drug Application submission to the FDA in Q4 2026.
As COMP360 moves toward potential approval, COMPASS Pathways launched a grant program to fund the development of high-quality provider training for the treatment's eventual rollout, and Fluence is proud to be one of the organizations selected. To learn more about COMP360 and COMPASS Pathways' research, visit compasspathways.com.
