Natalie Lyla Ginsberg (MAPS): The FDA, MDMA, and the Future of Psychedelic Therapy

Today, I’m joined by Juan Pablo Capello, co-founder and former CEO of New Life Health, a telehealth ketamine therapy service launched in 2021. Juan Pablo has raised concerns about low standards of care in telehealth ketamine, making this a timely conversation about the opportunities and challenges in this growing industry. In our discussion, Juan Pablo shares how his early experiences with Wachuma inspired his interest in psychedelics for mental health. We address key topics, including the potential for ketamine addiction, the impact of Matthew Perry’s death on the psychedelic community, and the surprising role of insurance companies in shaping telehealth standards. We also explore the Religious Freedom Restoration Act, Juan Pablo’s work with the Eagle Condor Church, and how integration is best approached as a community effort. Juan Pablo is a seasoned entrepreneur who co-founded a leading Latin American crowdfunding platform and a creative campus in Miami’s Wynwood Arts District. As the former CEO of New Life Health, now part of Beckley Waves, he continues to engage in work that bridges innovation, care, and community in the psychedelic space. Timestamps (06:00) Juan Pablo’s background in Chile and his experience with Wachuma (11:30) Why ketamine is used in mental health treatment (21:00) Is ketamine addictive? (25:00) Matthew Perry’s death as a wake-up call for the ketamine community (36:00) The surprising regulatory influence of insurance companies (41:00) The Religious Freedom Restoration Act and the Eagle Condor Church (53:00) The lack of integration in traditional psychedelic therapy contexts (57:00) Integration as a community-driven process Links Juan Pablo Cappello - PAG Law PLLC Matthew Perry's Death Shows Ketamine Industry Needs a Wakeup Call Nue Life | At Home Ketamine Therapy

Today, we’re exploring a critical issue facing the field of psychedelic medicine: the recent FDA rejection of MAPS’ clinical trials to reschedule MDMA for therapeutic use. This setback affects many of us committed to healing and transforming society through psychedelics.  To help us understand the impact and the path forward, I’m joined by Natalie Lila Ginsberg, a leading voice in the psychedelic field and MAPS’ Global Impact Officer. In this episode, Natalie and I discuss the importance of psychedelic therapy and her personal passion for this work. We cover the history of MDMA’s criminalization, the complexities of the FDA’s decision, and the split between MAPS and its public benefit corporation, Lycos. Natalie sheds light on why the FDA remains cautious and how psychedelic therapy may or may not fit into the Western medical model. Finally, she offers guidance for aspiring psychedelic therapists on the most valuable trainings and credentials to pursue. Natalie has led MAPS’ Policy and Advocacy Department, co-developed their Health Equity Program, and now champions the ethical integration of psychedelics into mainstream culture. Before MAPS, she was instrumental in legalizing medical cannabis in New York, and she co-founded the Jewish Psychedelic Summit. TIMESTAMPS (10:20) — What is psychedelic therapy and why is it important (17:00) — Natalie’s WHY (24:00) — Why MDMA is illegal (31:30) — Why the advisory board recommended the FDA not to deschedule  (34:00) — Why there was a split between the nonprofit MAPS and public benefit corp Lycos (41:45) — Why is the FDA so cautious (48:00) — Can psychedelic therapy ever truly fit into the Western medical model? (56:00) — Natalie’s recommendations for trainings and credentials that are worth investing in for psychedelic therapists LINKS Debunking FDA Advisory Meeting with Lauren Taus Multidisciplinary Association for Psychedelic Studies – MAPS Natalie Lyla Ginsberg, M.S.W. Global Impact Officer Natalie Lyla Ginsberg (@natalielyla)

Today we’re doing something a little different. I’m re-releasing an episode from my personal podcast, Life is a Festival, because it remains one of my favorite interviews ever. This conversation, originally recorded a few years ago, is with Tricia Eastman and Joseph Barsuglia, two pioneers in the world of psychedelic medicine. We dive deep into Iboga, the Bwiti people of Gabon, and the powerful pharmacology of this unique plant medicine. I wanted to share it with you as it remains highly relevant and educational. In this episode, we explore Iboga and its cultural and spiritual significance. We discuss the Bwiti people, their rituals and music, and how these elements interweave with Iboga's healing properties. Tricia and Joseph share their journeys as healers, their work with Iboga, and its connection to other psychedelics like 5-MeO-DMT. We also touch on the subject of microdosing Iboga and its suitability for this practice. Joseph and Tricia both worked at Crossroads ibogaine treatment center in Mexico. Joseph has co-led psychedelic retreats around the world since 2015 and serves as an advisor to numerous psychedelic medicine companies. Tricia Eastman is a renowned speaker and healer, with her book Seeding Consciousness: Plant Medicine, Ancestral Wisdom, and Psychedelic Initiation launching November 12, 2024. Together, they bring a wealth of wisdom to today’s discussion. Timestamps: (08:00) - Who are the Bwiti (17:00) - The Pharmacology of Iboga (29:00) - The meaning of Bwiti music and rituals (38:30) - Tricia and Joseph’s journeys to iboga  (46:30) - 5MeoDmt  (52:00) - Overcoming spiritual ego and supporting conservation (1:04:30) - Microdosing iboga  Links: Seeding Consciousness - Simon & Schuster Dr. Joseph Peter Barsuglia psychedelicjourneys - Tricia Eastman

After the shocking decision of an advisory committee recommendation that the FDA reject MDMA as a treatment for post-traumatic stress disorder, I wanted to speak to someone who understands the difference between clinical trials and private practice. Dr. Jennifer Tippett is a licensed clinical psychologist and Director of Psychotherapeutic Development at atai Life Sciences, where she creates therapeutic protocols and provides facilitator training for psychedelic clinical trials. On the show, we start with Jennifer’s experience in forensic psychology. Then we discuss the difference between industry trials, academic trials, and private practice. We talk about making novel psychedelics, and if it is possible, or desired, to make a psychedelic that doesn’t have the trip. We also discussed equity and access, including both cultural and financial barriers to psychedelic healing. Jennifer has spent a lot of time considering how one might create a sustainable business model for psychedelic therapy, especially looking at what has been going on in Oregon. As an employee of atai Life Sciences, which is a publicly traded company, Jennifer responds to some criticisms of for-profit psychedelic companies. And finally, we end with her response to the recent FDA advisory finding against using MDMA for post-traumatic stress disorder. Jennifer previously directed the Substance Use Disorder Specialty Program at the University of Denver, focusing on addiction and the neurobiology of trauma. Her early career involved working with incarcerated individuals and those with severe mental illness, inspiring her to explore innovative mental health care, including psychedelic medicine. Dr. Tippett studied psychedelics through shamanistic traditions and obtained certifications from Fluence, Polaris, MAPS, and the Integrated Psychiatry Institute. She is also a Level 1 Internal Family Systems provider, dedicated to integrating psychedelics with evidence-based therapies. In her private practice she supports clients with psychedelic integration.  The views and opinions expressed by Jennifer in this episode are her own and do not necessarily represent those of atai Life Sciences.  Links Integration | Jennifer Tippett psychologist Jennifer Tippett, Ph.D. atai Life Sciences Timestamps (07:00) - Could psychedelic therapy help treat psychopathy?  (15:30) - The difference between industry trials, academic trials, and private practice (20:30) - Should we make new psychedelics? (25:00) - Equity and access, culturally and financially (30:30) - Creating sustainable business models for psychedelics therapists (35:30) - Could we have healing without the trip? (39:30) - Responding to criticism of for profit psychedelic companies (42:30) - Responding to FDA advisory board’s decision on MDMA

A year and a half ago, I went on an antidepressant medication, Wellbutrin, which is a dopamine and norepinephrine reuptake inhibitor. After 20 years of plant medicine, meditation, therapy, and other healing modalities, which I still use, I was still experiencing persistent challenges. With the support of my advisors and my doctor, I decided to an antidepressant while maintaining my alternative healing practices. Today on the show I discuss the intersection of psychopharmacology and psychedelics with a psychiatric pharmacist, Ben Malcolm. On the show, we talk about how Ben became a psychedelic pharmacist and how he created his website, Spirit Pharmacist. We discuss the origins of mental health treatment, the use of psychedelics and psychotropics together, and important contraindications for LSD, psilocybin, MDMA, ketamine, and ayahuasca. We cover the process of tapering off antidepressants, the reasons behind it, how it works, and the period needed for tapering. Ben also speaks directly to psychedelic practitioners. This is offered for informational purposes only, and I would direct you to Ben Malcolm's website for more specific answers. Ben Malcolm is a psychopharmacologist and professor of pharmacy with experience in plant medicine and psychedelics. He helps people get off psychiatric meds for journeys and is available to help you or your clients if you are in the healing arts. Ben Malcolm is a board-certified psychiatric pharmacist with a passion for psychedelic drugs, antipsychotics, antidepressants, and alternative medicines. He offers psychopharmacology consulting, educational courses, and a membership program at his website Spirit Pharmacist. Links Psychedelic Psychopharmacology Consulting and Education Spirit Pharmacist (@spiritpharmacist) Timestamps (09:30) - How Ben became a psychedelic pharmacist (14:30) - The origins of mental health treatment (21:30) - Using psychedelics with psychotropics (29:00) - Contraindications for LSD, psilocybin, MDMA, ketamine, and ayahuasca (45:00) - Tapering off antidepressants (59:00) - Ben speaks to psychedelic practitioners

Welcome back to the Psychedelic Therapy Podcast. I'm your host, Eamon Armstrong. Today on the show, we're welcoming back Tony Moss. Tony is an artist, producer, and member of the Bird Tribe Music Collective. He is also an ayahuasca facilitator with 30 years of experience and has just released a new album, Joy. In today's conversation, we discuss the magic and science of medicine music. We talk about the state of medicine work in 2024, why psychedelics change the way we hear music, and the difference between an Icaro, a medicine song, and other genres. We also explore the hymns of Santa Daime, Tony's gospel-inspired music, and his new album, Joy, which turns unexpected genres into medicine music. Tony is a recording artist, producer, and creative director. Born into a musical family of R&B gospel singers, he was raised in California's psychedelic and spiritual cultures. Inspired by over 25 years of working with plant medicines, Tony combines science, shamanism, and multiple music genres to create music dubbed "Soulful Ceremonial." Timestamps (05:00) - The state of medicine work in 2024 (10:30) - Why do psychedelics change how we hear music (18:30) - The difference between an icaro and a medicine song (29:00) - Some songs are medicine but not medicine music (35:00) - The Hymns of Santo Daime and Tony’s own Gospel inspired song Grateful   (42:30) - Does speaking without song work? (50:00) - Tony’s album Joy and making medicine music out of unexpected genres Links Tony Moss: Medicine Music Tony Moss (@mosstony) JOY | Tony Moss, Bird Tribe Previous Podcasts Tony Moss (I.AM.LIFE): So You Want to Be a Shaman? From Activist to Ayahuasca Advocate | Tony Moss (Bird Tribe) Ayahuasca for Healing Ancestral Racial Trauma | Tony Moss

Welcome back to the Psychedelic Therapy Podcast. After a hiatus of a year and a half, we're excited to announce our return, thanks to our new sponsors, Hurricane Lotus (formerly Maya, the original sponsor of this show) and Holos Global, we are now back and releasing regular episodes. On today's show, I’m speaking with Alexander Beiner, author of "The Bigger Picture: How Psychedelics Can Help Us Make Sense of the World." We discuss the roots of the mental health crisis, the role of psychedelics in healing, and what healing actually means according to Beiner. We also explore understanding existential risks and how this relates to psychedelic healing, as well as the ethical dilemmas in psychedelic healing. We conclude our conversation with Alexander's account of his extended state DMT experience at Imperial College London and his belief in the power of the teaching presence. Alexander Beiner is a writer, cultural commentator, and podcaster. He's one of the founders of Rebel Wisdom, a media and events organization with a quarter of a million subscribers and a focus on making sense of culture and complexity. He's also an executive director of Breaking Convention, Europe's longest-running conference on psychedelic science and culture. He is a leading critical and countercultural voice in the "psychedelic renaissance" and has produced a number of films, articles, and events at the leading edge of the conversation about the potential of psychedelics. Timestamps: (07:00) - The Roots of the Mental Health Crisis (13:00) - The Role of Psychedelics in Healing (23:00) - Understanding Existential Risks and Psychedelic Healing (33:30) - Ethical Dilemmas in Psychedelic Healing (42:30) - Alexander’s Extended State DMT Experience and the Teaching Presence Links: Alexander Beiner: Sensemaking The Bigger Picture The Bigger Picture | Alexander Beiner | Substack Alexander Beiner (@alexander_beiner) Breaking Convention

Today on the show we are discussing the state of psychedelic legislation in the wake of Colorado’s Proposition 22 passing in November. Sharing the most relevant implications for psychedelic therapists and healers we have the best person for the job, MAPS Director of Policy and Advocacy Ismail Lourido Ali. On the show we discuss legalization vs decriminalization. We look at the different tracks for psychedelic legalization from medicalization to religious exception to regulated adult use. We discuss Oregon’s Bills 109 and 110 exploring “scope of practice,” residency laws, and training reciprocity. We look at Colorado’s Proposition 22 and the two big differences between that and what was passed in Oregon two years ago. We discuss equity initiatives. Ismail shares what legalization efforts look like on the federal level and to close our conversation, he speaks directly to psychedelic healers. As MAPS’ Director of Policy and Advocacy, Ismail advocates to eliminate barriers to psychedelic therapy and research, develops and implements legal and policy strategy, and supports MAPS’ governance, non-profit, and ethics work. Ismail earned his J.D. at the University of California, Berkeley School of Law in 2016, after receiving his bachelor’s in philosophy from California State University, Fresno. Ismail has previously worked for the ACLU of Northern California’s Criminal Justice & Drug Policy Project, and Berkeley Law’s International Human Rights Law Clinic. Ismail is licensed to practice law in the state of California, and is a founding board member of the Psychedelic Bar Association. Ismail is passionate about setting sustainable groundwork for a just, equitable, and generative post-prohibition world. Timestamps :06 - Izzy’s role as Director of Policy and Advocacy for MAPS :10 - Legalization vs decriminalization :16 - Religious exception vs medicalization :22 - Oregon’ regulated adult use system (Bill 109) :28 “Scope of practice” and psilocybin facilitation licenses in Oregon. :34 - Information for practitioners hoping to offer services in Oregon or Colorado including residency laws and training reciprocity :40 - Two big differences in the recently passed Colorado’s Prop 22 :47 - Equity initiatives in Oregon and Colorado :54 - What can we anticipate around federal legislation in psychedelics Links Izzy’s Instagram Izzy Twitter Multidisciplinary Association for Psychedelic Studies - MAPS MAPS Twitter MAPS Instagram Psychedelic Bar Association Guide to RFRA and Best Practices for Psychedelic Plant Medicine Churches Oregon Health Authority MAPS analysis regarding Oregon’s Measures 109 and 110 passed in Nov 2020 MAPS analysis regarding Colorado Proposition 122 MAPS analysis regarding our work on SB519 in CA to decriminalize the personal use of all psychedelics

Could enhancing creativity be the key to healing mental illness? Laura Dawn of Grow Medicine, makes a compelling case for the value of psychedelics for enhancing flow. Our conversation begins with an exploration of eldership and indigenous concepts of reciprocity based on Laura Dawn’s recent trip to Columbia. Laura Dawn gives us practical tools for enhancing creativity and makes the case for psychedelic healing through optimizing flow states. We conclude with how to prevent burnout amongst healers, facilitators, and other leaders in the psychedelic space. Laura Dawn hosts The Psychedelic Leadership Podcast and is the founder & director of Grow Medicine. She has a Masters in Science specializing in Creativity Studies & Change Leadership and is at the forefront of exploring the intersection between psychedelics and creative cognition for leadership development. Timestamps :05 - Laura’s trip to Colombia to learn from the Kogi and Mamos indigenous elders :19 - How to best innervate psychedelics into the mainstream :24 - Focusing on the intersection between psychedelics and creative cognition :34 - Healing mental illness through creativity tools for accessing creative cognition :49 - How to prevent burnout amongst healers, facilitators, and people in the psychedelic space Links Grow Medicine Website Laura Dawn Website Instagram

Can sound help us disconnect from unhealthy habitual patterns? Today’s guest Alexandre Tannous, creator of the Sound Meditation protocol, shows how we can use harmonic frequencies to release trauma, enhance self-awareness and live happier, healthier lives. Our conversation begins with Alexandre’s explanation of harmonic frequencies and the problem with the quantization of the 12-tone scale. We discuss the value of sound in the context of psychedelic experiences, as well as sound meditation protocols (set and setting). We conclude with issues that need to be addressed when working with these powerful tools. Alexandre Tannous is an ethnomusicologist, sound therapist, and sound researcher. He is also the Principal Founder of ResonantMind Collective. For the past 22 years Alexandre has been researching the therapeutic and esoteric properties of sound from three different perspectives – Western scientific, Eastern philosophical, and shamanic societal beliefs – to gain a deeper understanding of how sound has been used to affect human consciousness. This search has led him to where art, science, philosophy, and spirituality intersect. He continues to do research on sound, currently works as a sound therapist, teaches the method he has created, and lectures about sound throughout the world. Timestamps :08 - An overview of sound and the 12 tone scale :20 - The problem with calling supplements “plant medicine” Ability to experience the transformational quality of sound in the context of a psychedelic experience :28 - Default mode network :37 - Alexandre’s specific protocol for Sound Meditation :44 - The impact of the Sound Meditation Protocol :54 - The pitfalls of powerful tools and the parasitic force Links Alexandre Tannous Website Resonant Mind Collective