Tryp Therapeutics has partnered with Fluence on the psychotherapy design for upcoming Phase 2a clinical trials. Having recently completed the initial training for a Tryp-sponsored study at the University of Florida for overeating disorders, Dr. Elizabeth Nielson, Co-Founder and Lead Trainer of Fluence, recently sat down with us to discuss the role of psychotherapy in treating patients with psychedelic drug products.
What interests you about the use of psychedelics as a therapeutic treatment?
Psychedelic-assisted therapy, a clinical practice where patients take a psychedelic in the context of treatment and a relationship with a trained therapist, have the potential to harness some of the most powerful and moving types of experiences humans can have in the service of healing from specific mental health problems. In addition, the conversation about integrating psychedelic experiences into healthcare requires reconsidering prohibitive drug policies and the exclusion of conversation about the potential benefit of such experiences, regardless of their setting or context. Furthermore, the early success of these transdiagnostic therapies in research settings begs a reexamining of some of our basic conceptualizations of mental suffering. At Fluence, we think the use of psychedelics as therapeutic treatments is interesting on all of these levels and welcome the continued conversation they evoke in our field.
Can you tell us a little more about Fluence and the approach you are taking to the psychedelic space?
Fluence is a training program that offers services to individual therapists seeking training, to groups of therapists working together, and to drug companies looking to design and deliver training to research therapists. Part of our mission is to expand access to training, make the expertise our team has developed in research trials more broadly available, and offer larger scale solutions that reflect that expertise and cross-pollination of knowledge. We formed Fluence to be a solution to the field’s training needs, and in doing so set the standard for high quality, thoughtful, thorough, and ethical training and clinical practice.
Can you share how you think about psychedelic assisted therapies and the potential they have to help patients?
Psychedelic-assisted therapies have the potential to build on the strengths of the existing mental healthcare system, while also helping it evolve and generate entirely new solutions. For instance, psychedelic-assisted treatments require interdisciplinary teamwork between professionals, and largely ask the treatment providers to step out of the traditional psychotherapeutic role and trust the patient’s mind and natural wisdom in their own healing process. That kind of trust can require a real paradigm shift from traditional approaches where the provider is seen as the expert and expected to assess symptoms, offer solutions, ultimately provide a cure. Psychedelic-assisted therapies, on the other hand, ask the patient to be an active participant in the process, to generate their own insights and directions, and develop autonomy, all in the setting of the psychotherapist’s support.
Can you explain the integral role psychotherapy plays in psilocybin assisted therapies?
Psilocybin is one of a family of “classic psychedelics” which are known for their ability to invoke deeply insightful, meaningful, spiritual, creative, and/or autobiographical experiences. When incorporated in to psychotherapy the therapist creates a container that is both physically and emotionally safe, where patients can fully let go into their experience without fear for their relationship with the therapist or any need to feel self-conscious. In this way, the therapeutic relationship should align with the effects of psilocybin, facilitate the patient’s full immersion in the psilocybin experience, and their potential for drawing insights out of the experience.
You’ve previously talked about using a therapeutic approach called Psychedelic Harm Reduction and Integration. Can you share what this means to Fluence?
Over several years of clinical practice both Dr. Gorman and I found ourselves blending the principles of Integrative Harm Reduction Psychotherapy with our knowledge of psychedelic-assisted therapy and several key principles from psychodynamic and mindfulness-based therapies in order to help people who were coming to us with questions about psychedelic experiences. We developed the Psychedelic Harm Reduction and Integration (PHRI) approach out of this work. It is a theoretically grounded and practical way of incorporating conversations about psychedelic experiences (or the desire to have psychedelic experiences) that patients may bring to therapy, and can be blended into a variety of other psychotherapy modalities, such as ACT or psychodynamic therapies. In general, most psychotherapies don’t have a specific framework or set of guidelines for incorporating with psychedelic experiences, and most therapists haven’t been taught anything about how to talk about them in psychotherapy, so we see this as a broadly compatible add-on approach that therapists can use.
What made you excited about working with Tryp Therapeutics?
When we first spoke with the Tryp Therapeutics team I was really heartened by the idea of working with diagnostic categories for which there are no treatments, or no treatments that can potentially help in the holistic way psychedelic-assisted therapy might. They are also paying attention to diagnostic categories that are stigmatized, poorly understood, and not receiving as much attention and research funding as others. The field of psychedelic medicine’s focus has been nearly exclusively on mental health, but those who suffer in other ways, such as with the diagnoses that Tryp Therapeutics is researching, are every bit as deserving of care and help as anyone else, and we are proud to contribute what we’ve learned in mental health care to these efforts.
Can you explain Fluence’s partnership with Tryp Therapeutics? How will Fluence assist Tryp in their clinical trials?
Fluence has consulted with Tryp Therapeutics on the development of the therapy manual for their Phase 2 study of psilocybin for overeating, developed materials for training therapists in this modality, and delivered the initial training for a cohort of therapists that will carry out the study. Throughout the study we plan to continue providing consultation and support, as well as ongoing support for therapists who work on the study to ensure they are able to conduct the therapy as intended. In the future we’ll be collaborating on other projects for other indications, including providing scalable training for larger trials and any approved indications to the larger market.
Fluence conducted the training of psychotherapists for Tryp’s upcoming Phase 2a clinical trials for overeating disorders. Can you share more details about the importance of that work and how it will relate to the patient experience in the clinical trials?
Training for therapeutic work on a clinical trial is specific to the trial, the diagnosis, the actual psychedelic offered, and the treatment approach taken. As such, it is always necessary to have specific training for a clinical trial to ensure clinicians are acting in ways that are consistent with the manual and with each other. If that consistency can be achieved we can attribute the outcomes to the actual treatment and/or condition, as opposed to different therapists acting in different ways. We also know that we are testing what we intended to test, as opposed to a therapist’s regular therapeutic approach, which might be helpful, but not what was intended to be measured in the trial.
How do you see psychedelic medicines making an impact on healthcare as a whole in the future?
At Fluence we’re hopeful that training in psychedelic therapies, including integration therapy, will help the mental healthcare field think differently about mental health, and about human suffering and therapy more broadly. Trainees already tell us that the psychedelic therapy concepts they learn at Fluence are easily integrated into their regular work with patients, engendering for instance more embodied presence, more development of the patients’ insights and autonomy, and a more open approach to the patient’s experiences of themselves. I envision a world where the key concepts of psychedelic therapy have broad influence on the way therapists see the role of the therapeutic relationship in empowering their patients’ own process of insight and recovery.
What obstacles need to be overcome to bring psychedelic therapies to patients? What do you think fundamentally needs to change in order for there to be broader medical accessibility?
Although early results are promising, research in this field is really in its beginnings. We need additional research studies; philanthropic, public, and private funding; and expertise to be shared across the field such that we can find the safest and most effective ways of bringing psychedelic therapies to a wide range of diagnostic categories. At this time the biggest need is for collaboration and shared knowledge, which includes the publication of research results, sharing of training program protocols, and publication of treatment manuals and standards. Fluence offers training in a variety of modalities and consultation to a variety of industry partners such that our expertise can be shared and widely available. Our trainers have experience on multiple research studies with multiple psychedelic therapies so we can cross-pollinate ideas and bring the best possible expertise to each project.