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Oregon Issues First Psilocybin Licenses. Now What?

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Last week, the Oregon Health Authority (OHA) awarded a pair of psilocybin manufacturer licenses. First two!

Congrats to Tori Arbrust of Satori Farms PDX, and Andres Met of Satya Therapeutics, known to many of us from the Oregon cannabis program. We should also congratulate OHA, which had aimed to issue manufacturing licenses by the end of Q1. The Authority continues to meet externally and internally generated program deadlines.

Following issuance of these licenses, OHA also mentioned that “we expect to be licensing a laboratory, service center, and facilitators in the coming weeks.” Getting a lab online (at least one!) and a couple of service centers would be good: psilocybin mushrooms grow quickly, and these new licensees will be turning out batches in six weeks or so. All of that said, I continue to expect the program to be constrained for a while, and choppy.

Sometime after my write-up back on January 26 analyzing the slow start of Oregon’s psilocybin program, OHA began to publish weekly statistics on the amount of applications received and processed. Various people have complained that the data is awkwardly presented; I agree with them. Nevertheless, here’s what the report showed on March 22.

Application Type            Submitted Apps             Incomplete Apps               Approved Apps         
Manufacturer 15 11 2
Service Center 9 5 0
Laboratory 2 1 0
Facilitator 21 0 0
Worker Permit 177 94 48

Too many psilocybin facilitators

Yes, OHA data shows only 21 submitted applications. However, the data doesn’t include a large number of training program students and graduates, many of whom will pile into the licensing portal shortly. To wit, over 100 would-be facilitators graduated from the InnerTrek program a few weeks ago. And InnerTrek is just one of 22 certified training programs (Synthesis is still on that list somehow).

How will these hundreds of facilitators find placements at licensed service centers? Friends, they won’t; the ratio is out of whack. Of those who make it through, what sort of pay can they expect? I’m guessing it won’t be much, and that they’ll have insufficient leverage to dodge the outsized tax bite that could be taken by IRC 280E.

I expect the number of facilitators to outpace service centers at least through the end of 2023. Hopefully, many of these people have other employment to see them through, especially after shelling out $8,000 for training fees and another $2,000 for licensing. This will be a pain point.

Not enough testing labs

Opposite problem with labs. Only two laboratories have bothered to apply, and one of them hasn’t completed its application. Anyone who was around for the cannabis labs bottleneck, back in the day, will tell you that these bottlenecks are a bear. Here’s what I wrote about psilocybin testing labs in February of 2022:

It is an open question whether OHA licensed, ORELAP certified cannabis labs will bulk up and “pivot” to the psilocybin space. It would be challenging to make cannabis testing equipment work for psilocybin in most cases. Psilocybin is water soluble (see, “mushroom tea”) whereas cannabis is fat soluble (see, “CBD gummy”). The labs that currently test cannabis in Oregon typically extract through CO2, hydrocarbon, butane or ethanol.

Because of this fundamental incompatibility, we may instead see new labs come online. Or, we may see legacy labs move over from traditional fields like water testing. An issue for many there would be fear of expansion into a controlled substances space, due to federal funding and liability issues.

It doesn’t appear that new labs are coming online, and it doesn’t appear that legacy labs are “moving over from traditional fields like water testing.” Often, legacy labs have no desire or ability to move into a controlled substances space due to government grants and contract status alluded to above.

Problems may surface for Oregon psilocybin due to lab scarcity. These include testing delays; geographic access hardship; price inflation; and testing integrity issues. Watch this space.

Big picture

I’m not here to bury the psilocybin program. I’m impressed by several of our clients moving into the space, including the handful of potential manufacturer and service center licensees we’ve been lucky to represent. Many of these people aren’t even in it to make money, necessarily; they are mission driven.

As we’ve been saying from the outset, though, we want people moving into the space with eyes wide open. The OHA program will be slow and clunky for a while– an airplane being built after launch. There will also be access issues on the user side (socioeconomic primarily, and geographic), which are outside the purview of this particular post.

In all, I expect the distribution, sale and consumption of psilocybin to occur mostly outside of the regulated space in Oregon– not just while the airplane is built, but at least for a couple of years. It will be nothing if not interesting. Stay tuned.

Source:  https://harrisbricken.com/psychlawblog/oregon-issues-first-psilocybin-licenses-now-what/



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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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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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Treating Depression: Psychedelics vs. Antidepressants

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Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches. Psychedelics vs. Antidepressants: What are the key differences?

Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants

The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.

A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.

Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.

Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.

Psychedelics vs. Antidepressants: Why It Matters?

Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.

Potential Implications

This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.

What Next?

While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.

Source: Neuroscience News



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