Dr. Benjamin Brody, an inpatient psychiatrist who built and now directs one of the earliest hospital-based ketamine treatment programs, joins Dr. Ben Everett to unpack the regulatory maze surrounding ketamine and the psychedelics now approaching FDA approval. Dr. Brody traces how he moved generic racemic ketamine from an overlooked anesthetic sitting on the hospital pharmacy shelf to a formally sanctioned inpatient treatment, and explains why esketamine's REMS-regulated pathway looks nothing like the largely unregulated market for take-home ketamine.As synthetic psilocybin nears a possible FDA decision and the field debates what role psychotherapy should play alongside these treatments, clinicians face fast-moving questions about safety monitoring, staffing, informed consent, and reimbursement. Drawing on his direct experience administering ketamine on the inpatient unit, Dr. Brody discusses self-escalation risk, the paradox reaction his team termed dysphoric dissociation, and what health systems should weigh before building a program of their own.🎯 KEY EPISODE HIGHLIGHTS:⚠️ THE NARROW LINE BETWEEN NEUROTROPHIC AND NEUROTOXIC [18:30]“But at higher doses, it actually becomes neurotoxic and, you know, there's histopathological changes that can be seen.”At therapeutic doses ketamine is safe and neurotrophic, but Dr. Brody warns that self-escalating doses can quickly cross into neurotoxic and bladder-damaging territory.🧠 DEFINING DYSPHORIC DISSOCIATION [24:00]“This is a dysphoric piece or a dysphoric reaction that is layered on top of the dissociative experience for this small minority of patients.”Dr. Brody explains why his team coined a new clinical term to distinguish ketamine's rare, frightening paradox reaction from a psychedelic “bad trip,” and why naming it matters for informed consent.🚫 THE CASE AGAINST TAKE-HOME KETAMINE [25:00]“The unambiguous answer is no, I do not think this is a good idea.”Citing self-escalation risk, a narrow therapeutic index, and a growing number of ketamine-associated deaths, Dr. Brody explains why he opposes direct-to-consumer telehealth ketamine prescribing.CHAPTERS:00:00 – From Creative Writing to the Inpatient Unit02:30 – A Day in the Life of an Inpatient Psychiatrist05:30 – How Dr. Brody Came to Believe in Ketamine12:00 – Ketamine vs. Classical Psychedelics: A Different Mechanism14:00 – Two Regulatory Worlds: Racemic Ketamine and REMS-Regulated Esketamine17:30 – Safety Signals: Self-Escalation and Dysphoric Dissociation24:30 – The Case Against Take-Home Ketamine29:30 – Psychedelics Enter the Medical Mainstream33:30 – What to Expect When Psilocybin Gets FDA Approval39:00 – Staffing and Consent for Hours-Long Sessions43:00 – Set and Setting: Lessons from Building a Ketamine Program48:00 – Is This Psychotherapy? Defining the Clinician's Role54:00 – What Surprised Dr. Brody About Implementation57:00 – Advice for Health Systems and Reasons for OptimismLINKS:Full transcript and show notes:https://www.psychiatrist.com/jcp/ep22-regulatory-maze-ketamine-psychedelics-benjamin-brody/ Journal of Clinical Psychiatryhttps://www.psychiatrist.com/jcp/ Publisher of peer-reviewed research discussed in this episode.How Do We Get Ketamine Safety Right? Three Questions From a Clinical Servicehttps://www.psychiatrist.com/jcp/how-do-we-get-ketamine-safety-right-3-questions-from-clinical-service/ Dr. Brody's 2025 JCP commentary on self-escalation, paradox reactions, and the regulatory gap between racemic ketamine and esketamine, discussed at length in this episode.COMPASS Pathways – COMP360 Psilocybin for Treatment-Resistant Depressionhttps://compasspathways.com/our-work/comp360-psilocybin-treatment-in-trd/ The investigational psilocybin program discussed throughout the episode, including its phase 3 timeline and proposed psychological support model.Dr. Benjamin Brody – LinkedInhttps://www.linkedin.com/in/benjamin-brody-md-3576bb4/ #Ketamine #Psychedelics #TreatmentResistantDepression #Psychopharmacology #REMS

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