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Utah Ketamine Clinic Update | Cannabis Law Report

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Last summer, my colleague, Ethan Minkin, published a post entitled “Utah Ketamine Clinics Face New Patient Monitoring Law.” The law in question applied a host of new requirements on anesthesia or sedation providers, which created a series of hurdles for ketamine clinics. A few weeks ago, a Utah state legislator submitted a bill that would add to this law new requirements for Utah ketamine clinics specifically. Even though the amendment would only affect Utah providers, it may have broader implications for ketamine clinics elsewhere. The amendment is relatively short and straightforward, and I’ll explain it below.

Utah’s current anesthesia and sedation law

Before explaining the proposed legislation, I recommend that readers go back and carefully read Ethan’s prior post if they want to understand the specifics of Utah’s anesthesia and sedation law. In a nutshell, it imposes requirements based on the level of sedation (e.g., minimal sedation, moderate sedation, deep sedation, or general anesthesia). The law imposes different requirements on different types of sedation, including specialized informed consent requirements, training requirements, supervision requirements, and more.

Notably, “minimal sedation” providers are exempt from a series of provisions in the law. One such exemption is the requirement that applies for other forms of sedation to have “at least one individual in the procedure room who has advanced airway training and the knowledge and skills to recognize and treat airway complications and rescue a patient who entered a deeper than intended level of sedation.” In other words, minimal sedation providers – under the law – are not required to have such a person on site.

Utah’s proposed “anesthesia amendments”

That brings us to the new piece of proposed legislation. The bill in question is numbered SB 197 and is referred to as “Anesthesia Amendments.” All it does is add the following language to the law:

“if the anesthesia or sedation provider is administering ketamine for a non-anesthetic purpose, having at least one individual on site and available who has advanced airway training and the knowledge and skills to recognize and treat airway complications and rescue a patient who entered a deeper than intended level of sedation.”

In other words, if the bill passes, ketamine clinics – even ones using ketamine for non-sedative purposes – will now need to have one or more individuals with advanced airway training and specialized knowledge and skills available.

The bill was just introduced in early February and there’s no guaranty it will become law, or that it won’t be heavily modified along the way. If it does become law, ketamine clinics will need to ensure that they follow the law, or they could risk a gamut of potential penalties.

Implications for ketamine clinics nationwide

I mentioned above that I think the law could have broader implications outside of Utah. In our experience, most states don’t have healthcare laws on the books that specifically apply to ketamine clinics. Healthcare providers in these states are guided by whatever state or federal general healthcare laws apply, such as restrictions on administering controlled substances, informed consent requirements, and so on. To us, it seemed inevitable that states would eventually realize that there is a growing market for ketamine clinic services, where ketamine is often administered in an off-label manner. And once states realize this, it’s only a matter of time until they start legislating and regulating.

So while Utah’s law may seem insignificant or (in other states) entirely irrelevant, I’d say to actually watch the state closely. It could be that more and more states start to follow suit and go even further with ketamine clinic regulations in the coming years. Stay tuned to the Psychedelics Law Blog for more details.

Author information & source

See https://harrisbricken.com/psychlawblog/utah-ketamine-clinic-update/



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Lykos In Patent Mode On MDMA

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We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

We don’t believe in taking out IP on MDMA

oh actually we do

 

 

Double Blind

In a shocking move that contradicts its previous stance on intellectual property, Lykos Therapeutics (formerly known as MAPS PBC) — the organization leading the movement to legalize MDMAassisted therapy — has filed multiple patent applications for specific forms and formulations of MDMA. Prior to this revelation, which was first reported on by Psychedelic Alpha, Lykos had long been praised in the psychedelic community and media for its “altruistic stance” in not seeking patent protections as part of its strategy, instead choosing to publish its research findings in scientific literature.

MAPS’s anti-patent stance, which intended to prevent MDMA from being monopolized, stood in stark contrast to the aggressive patent strategies of competitors like Compass Pathways and Atai Life Sciences. Rick Doblins, the founder of MAPS, had been analyzing the non-patentable status of MDMA since the late ‘80s, and in an article titled “MDMA Patentability and Orphan Drug Designation,” published in 1992, he wrote:

“It could be a major setback if MAPS funded MDMA research and secured approval for its medical use only to have someone else control it through an inexpensively obtained use patent.”

Read more

Lykos Therapeutics Quietly Moves to Patent MDMA

 



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Press Release: PsychedelicNewsWire Named Official Media Sponsor of the 4th Annual Psychedelic Therapeutics and Drug Development Conference

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LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024



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individualized treatment

Risks of Psychedelics for People with Personality Disorders

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While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.

Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders

Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.

The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.

Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.

This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.

Why It Matters

The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.

Potential Implications

The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.

The Bigger Picture

The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.

Source: Science Alert



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