Psychedelic: Exclusive talk with mental healthcare company Numinus

In this edition of “Psychedelic”, The Fly conducted an exclusive interview with Amanda Giesler, Director of Training at Numinus Wellness (NUMIF), a company advancing traditional and innovative behavioral health treatments. Here are some highlights:

TRANSFORMATIVE HEALING: Numinus aims to help people heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The company’s clinical trial research and comprehensive practitioner training programs are at the forefront of its strategy to integrate these therapies into mainstream clinical practice and build the foundation for a healthier society.

“When we were founded in 2018, the key goal leading us to our strategy was bringing transformative healing to humanity,” Giesler said. “Our three core pillars were our clinical services, providing real client care with various psychedelic medicines, our clinical research, gathering data on new medicine formulations to hopefully expand the psychedelic treatment options in our mental health toolkit, and then lastly but certainly not least, our practitioner training,  providing good quality evidence-based certification training so folks feel like they have the tools that they need to provide this safe and effective care.”

Those pillars were complementary and cyclical, she said, as clinical research provided evidence and learning that was then brought into clinical service delivery, which provided experience through the company’s clinics allowing Numinus to share that knowledge with other practitioners looking to do the work in a safe and effective way.

“The cyclical balance between those three served each other really well,” the director said. “And of course, once we had that robust practitioner training that then fed back into our clinics, because that became what we use to train all our new practitioners. Obviously, the clinic piece is not a core component of our business anymore as we shifted priorities, but the strategy when we were founded was that those three would feed well into each other and we would learn along the way as the field evolved and shifted through time.”

COMPETITIVE EDGE: When asked about competition in the psychedelic-assisted therapy space, Giesler said Numinus has developed very credible training programs through the expertise of its clinical research center.

“Then afterwards, we thought that it was incredibly important in both Canada and the U.S., to be accredited under numerous regulatory bodies,” she said. “Our plan is to continue making sure we are an approved program, wherever in the states or Canada they release new legislation or program requirements. We will follow suit, and we constantly watch the evolving legislation around that to make sure that when you think of Numinus training, you think of the most credible training program that practitioners can get.”

The director added that Numinus offers experiential learning components in its programs to allow learners the opportunity to get first-hand experience with psychedelic medicines. “Where permitted, we offer optional experiential components through sanctioned and carefully facilitated programs, so practitioners can better understand the therapeutic container and support clients more empathically. These components are never required and always comply with local laws and ethics standards,” she said. “This can help practitioners dig deeper and have that bond with clients. We also have heard from clients that they feel a little bit safer and more comfortable knowing that their facilitator has had that experience and understands what they are going through.”

Numinus includes experiential learning in a couple of places in its training and offers the opportunity for a cacao ritual at the very top of its certification pathway in its ‘Fundamentals of Psychedelic-Assisted Therapy’  course, Giesler said. “We are honored to collaborate with an Indigenous Knowledge Keeper from Mexico, who offers teachings in a culturally respectful and consent-based format for this ritual,” she said. “Folks learn how to prepare together and there’s some ritual and ceremony as part of that. Not only are they getting experience with a gentle medicine with their classmates, but they’re also starting to develop those group competencies. How do we keep each other safe? How do we hold respect for each other? Not only that, but it is also such a heart opener. Something I hear consistently in our classes is that they have built strong friendships, even in this short 10-week course.”

At the end of the certification pathway, Numinus offers practicums but also experiential learning opportunities where the practitioners, where permitted by law and under licensed facilitation, may have the opportunity to observe or participate in sanctioned sessions with psychedelic medicines to deepen their understanding of therapeutic protocols and the client experience, the director said.

“Also practitioners that come to our program are usually really busy humans that have lots going on in their lives,” she said. “When we were building our curriculum, we tried to think about the most flexible way for practitioners to come through a certification program. For us, we have structured our curriculum in a cohort-based format allowing people to come through course requirements as they have time in their schedules. That’s been really effective.”

Giesler added that the alumni network is also important to the company’s training program to ensure practitioners are supported beyond the certification they receive.

“They have done all this work with us and we want to make sure that they still feel really connected and supported when they actually go into doing this practice,” she said. “We have our alumni network, which includes a group chat to stay connected with each other and ask questions, but we also host bi-weekly supervision and mentorship groups. That allows folks to drop in whenever they want to come forward with a case or a question and there’s no cost to that. It’s just our way of making sure that they feel really supported when they start implementing this into their own practice.”

The director also noted instructors in the training program are actively practicing psychedelic-assisted therapy in real time when they’re not teaching. “They are actively seeing clients, they can answer questions diligently and they understand how the changing landscape and political climate around us affects psychedelics,” she said. “When you’re looking at a Numinus training program or any kind of psychedelic-assisted therapy program, you should make sure that those instructors assigned there are actively practicing psychedelic-assisted therapists.”

COLORADO CERTIFICATION: In March, Numinus announced that its Psychedelic-Assisted Therapy Training Program had been approved by the state of Colorado as part of Colorado’s Natural Medicine Health Act, which establishes a legal framework for the facilitation of psilocybin services by trained and licensed professionals.

“First off, I’ll just say kudos to Colorado, but also to Oregon,” Giesler said. “It takes so much work to provide good legislation and very clear program guidance for getting approved in those states and that is a key step to making sure you have a really good system of care and accessible psychedelic-assisted therapy. We knew Colorado has been a champion for psychedelic-assisted therapy for a long time and so we were pleased to see that they were considering opening up to more programs.”

As Numinus designed its training program in cohort-based learning formats, it made it flexible and easy to add additional curriculum requirements to ensure the company met what Colorado needed in their program, she said.

“We just want to make sure that regardless of which state comes through and provides these clear pathways for providers to get certification, that we’ll be right there behind them all,” the director said. “I anticipate that Colorado was one of the first two of hopefully many that will open up and we’ll be getting state certification more broadly in the U.S.  But for us, this just allows us to be really tailored to Colorado-specific needs and concerns.”

Numinus also partners with Center Origin in Denver, Colorado, she said, to provide experiential and practicum components of the company’s certification pathway. “As I think about the Colorado practitioners getting that experience in their own state, with mentors that have all this experience from their local geographic area, I just think that is so incredible and amazing,” Giesler said. “I am just proud that that is a key component of our certification pathway and again, its fundamental to being able to provide practitioners this solid training so they can go ahead and provide safe and effective care to clients in the state.”

SCHEDULING: Several psychedelics are listed as Schedule I drugs under the Controlled Substances Act, and the director said she believes the restrictive status limits research opportunities for medical professionals to explore the therapeutic potential of these drugs.

“Obviously there are ways around this and as you see, psychedelics are starting to open up a little bit more and we have been growing the evidence,” she said. “But ultimately, as soon as you put Schedule I on a drug, there is this public and political stigma. Hopefully that will shift through time. I do think things like the breakthrough therapy designations that have been happening have made really huge strides in opening the public eye in realizing that this is just another tool in our toolkit for mental healthcare in North America.”

Giesler said she hopes these medicines reach a point of normalization, where when a person thinks about these options, they think about how great they can be for people who have various mental health conditions. “I’m hoping that because of all this great research and these breakthrough therapy designations, we’ll see shifts of that over time as well as more and more legislative change and increased access to psychedelics,” she said.

ELECTION RESULTS: In this year’s U.S. election, Massachusetts voters rejected a ballot measure that proposed decriminalization of psychedelic use for people older than 21 and the director said she believes research around psychedelics was not well-articulated for Massachusetts’ public.

“I also heard things like the ballot was a little bit confusing and it seemed like there were multiple components within the same ballot question,” she said. “It seemed like a lot of people were pro-potential medicinal benefits but then there were also pieces to it that enabled the for-profit facilities and unregulated practices to emerge, which may have contributed to voter hesitation. I think that’s where people got nervous.”

Giesler said she expects the state to revisit the issue eventually following more public education and with a more clearly defined ballot. “I empathize with folks wanting to make sure that we get this right and not take any backwards steps in this space,” she said. “Everybody wants to be really careful and we are seeing a shift in society where mental health is a key priority as part of our total health package. So when we think about adding tools into treating severe mental health conditions and disorders, we want to make sure that people stay safe and have those transformative experiences with really robust training for practitioners.”

Also, in this year’s election, Donald Trump was elected president, and the director said it has been surprising to watch several of Trump’s nominees be publicly pro-psychedelic.

“The recent one I’ve heard is Dr. Marty Makary, Trump’s FDA commissioner pick, and now it’s on national television that they think the development of psychedelic treatments is one of their top priorities at the FDA,” she said. ‘That signals to me good signs for psychedelics in the U.S. There are several U.S. political figures that have also expressed support for psychedelic research, signaling bipartisan interest in the space. If Makary makes it through confirmation, I think there is potential to see the five breakthrough therapy designations being pushed forward.”

CHALLENGES: When asked about the largest hurdles facing the psychedelic space, Giesler noted that the FDA rejection of MDMA for Post-Traumatic Stress Disorder in August was a ‘bit of a gut punch’.

“Truthfully I thought we would see MDMA-assisted therapy for PTSD, especially accessible to veterans,” she said. “While that decision was disappointing, we respect the need for robust data and remain committed to contributing to the evidence base. The challenge is put onto the drug development companies to really figure out what it will take to get that approved and the research we need.Once they get that approval, we are excited to support rolling this out to the public safely.”

To do that, practitioners need to be trained and following a specific protocol to ensure these therapies are rolled out in a safe and effective way, the director said.

“Programs need to be time-effective, because we can’t cause huge delays for people to then get access, but they also do need to offer quality education and training,” she said. “Additionally, we need to think about accessibility and insurance coverage. We cannot leave behind the folks who are struggling the most. It’s counterintuitive when some of the most vulnerable clients in our society really need psychedelic-assisted therapy but they just can’t afford to even get to the facility, and then further than that, actually pay for the therapy.”

Constant public education and awareness also needs to take place, Giesler said, and the industry needs to ensure it is publicizing good psychedelic research so people can come to their own conclusions.

“People really need to look to the science and literature to make an informed decision on their own opinions about psychedelic-assisted therapy, which will reduce the stigma attached to psychedelics,” she said. “Psychedelic-assisted therapy is another tool in our mental health toolkit that we need to have available for folks to access should they want it or need it.”

OPPORTUNITIES: As the psychedelic industry develops and matures, the director said while Numinus has moved away from clinic operations, the company is excited for those who are finding new models to make this medicine more accessible.

“For us specifically, we are very excited about research and training,” she said. “I am so excited about the research studies that our team is participating in in the U.S. and I hope that their hard work will help contribute to opening different psychedelic-assisted therapy options.”

Giesler also mentioned she is personally excited about the opportunity for LSD in Generalized Anxiety Disorder. “MindMed (MNMD) is really leading the way, and I am excited for their results of their Phase 3,” she said. “I have got my fingers crossed that we might see them as one of the first drug development companies that get FDA approval. I’m just excited for commercialization and the opening up of different options so people can feel a better sense of hope that there are more options in their toolbelt.”

PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Clearmind (CMND), Compass Pathways (CMPS), Cybin (CYBN), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH research (GHRS), Incannex Healthcare (IXHL), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), NRx Pharmaceuticals (NRXP), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla Biotech (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX).