Intro speaker— Dr. Sokolowska
FDA does not regulate the practice of medicine.
Esketamine was approved in 2019 as a nasal spray for treatment resistant depression in conjunction with an oral antidepressant, and in 2020, was approved for suicidality.
The FDA has not approved ketamine for other mental health indications, nor pain conditions, and does not approve compounded medicines.
The FDA issued 2 risk alerts on compounded ketamine products.
In spite of this, the FDA recognizes the real-world use and ongoing study of ketamine in a variety of formulations.
Today’s meeting goals - expand knowledge, knowledge gaps, safety issues
Sanacora from Yale (affiliated with Johnson & Johnson and has several financial disclosures / conflict of interests as he profits from people being prescribed Jansen’s esketamine branded Spravato). History of ketamine - lists first study on antidepressant efficacy in 1990. (Inaccurate)
Mechanism of action - neural plasticity & NMDA receptors (circa 1990) - suggested depression was more of a cortical disorder
Found ketamine can have rapid, lasting antidepressant activity (notes small studies with small sample sizes) 2016 studies
Alleges very little clinical evidence, with evidence on neurotoxicity and brain lesions, unaware of the wealth of data at the time, yet was part of the American Psychiatric Association’s position statement on ketamine in psychiatric use in 2017.
Who will do multi-million dollar studies? Someone came up with the idea of using esketamine, half of what’s in normal racemic ketamine.
Esketamine, more potent at NMDA receptor. Jansen pharmaceucticals sponsored the studies required by the FDA, which approved the medicine in 2019. Data over 58,000 patients with 800,000 administrations of esketamine.
Compares to ketamine study of 195 people from 2019, does mention Osmind study, alleging community using higher doses
Rapidly shifting landscape, mentions recent oral and iv ketamine studies, alleging poor scientific rigor.
Make treatment available, but balancing with safety.
A more complete discussion on Sanacora later.
The Reagan-Udall Foundation for the FDA, in collaboration with the FDA, is hosting a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest." Ketamine is a Schedule III controlled substance that is FDA-approved for induction and maintenance of general anesthesia. Although ketamine is not approved for the treatment of conditions such as depression or chronic pain, there has been increased interest in it's use for these types of conditions. This public workshop will explore topics such as the scope of ketamine use, including approved products and compounded products, for these emerging areas of therapeutic interest; potential safety concerns; and online promotion of and access to ketamine.
Speakers will include clinicians, academic researchers, and federal partners. (No psychotherapists or psychedelic therapists are scheduled to speak.)
“After assessing the semantic similarity between 15,000 reports linked to the use of 165 psychoactive substances with 625 NDE {Near Death Experience} narratives, we determined that the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine consistently resulted in reports most similar to those associated with NDEs. Ketamine was followed by Salvia divinorum and a series of serotonergic psychedelics, including the endogenous serotonin 2A receptor agonist N,N-Dimethyltryptamine (DMT). This similarity was driven by semantic concepts related to consciousness of the self and the environment, but also by those associated with the therapeutic, ceremonial and religious aspects of drug use. Our analysis sheds light on the long-standing link between certain drugs and the experience of “dying“, suggests that ketamine could be used as a safe and reversible experimental model for NDE phenomenology, and supports the speculation that endogenous NMDA antagonists with neuroprotective properties may be released in the proximity of death.” (Neurochemical models of near-death experiences: A large-scale study based on the semantic similarity of written reports, Martial, et al, 2019).
Here ketamine, like DMT, is hypothesized to act on similar receptors to form similar brainwaves, with similar subjective experiences related to proximity to death.
More here— https://psychedelic-institute-of-mental-health.ghost.io/does-the-psychedelic-experience-matter/
Experiences of Awe Mediate Ketamine's Antidepressant Effects: Findings From a Randomized Controlled Trial in Treatment-Resistant Depression (Aepfelbacher, et al, 2024) https://pubmed.ncbi.nlm.nih.gov/38726038/
“ Ketamine infusion strongly induced heightened feelings of awe, and these experiences consistently mediated depression outcomes over a 1- to 30-day period, unlike general dissociative side effects. The specific awe-inspiring properties of ketamine may contribute to its antidepressant effects.”
February 2024: **Ketamine-Assisted Psychotherapy & Support Practicum **
Organizing our next round of ketamine therapy training for clinicians and non-clinician guides / trip sitters. Meeting 8 hours per week, this practicum includes 12 experiences with racemic ketamine in various routes of administration, 12 sessions of sitting with someone else under the medicine, 12 hours of didactic training, 12 hours of integration, 12 hours of individual clinical supervision totaling 96 hours of practical experience upon completion of all 12 modules.
Medical clearance by a prescribing clinician licensed in your home state or locality required.
The Psychedelic Institute of Mental Health & Family Therapy is located in Palm Springs, California. Practicum is held online 2 evenings per week, 3.5 hours each evening from 6-9:30pm PST, with an optional in-person retreat weekend.
Practicum Fee: $600 per person per 8 hour weekly module
Thanks for the post! I'm doing the great un-Redditing, and getting my lit review posts over here. Feel free to unsubscribe until it's done.
@PlanetMedicines
@lemmy.world