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Psychedelics industrial complex could put psychedelic religions in jeopardy

The Oregon Psilocybin Committee is considering special protections for the religious use of psilocybin after warnings that the industry could endanger psychedelic religions.



Psychedelics industrial complex could put psychedelic religions in jeopardy

A subcommittee of the Oregon Psilocybin Advisory Board (OPAB) is considering whether to provide special protections for religious practises involving the use of psilocybin.

The OPAB has been warned that the rise of a new psychedelics industrial complex could put psychedelic religions in jeopardy if Oregon fails to act quickly.

Attorney Jon Dennis of Sagebrush Law, warned the board that the industry has already begun engaging in aggressive tactics to prevent newcomers from entering into the industry, despite psychedelics not yet being legal at a state or federal level.

Although the US Supreme Court has already approved of granting religious liberties to churches that use psychedelic plants as sacraments, Oregon is the first state to decide the scope of freedoms for psychedelic religions through administrative regulation.

Measure 109

Oregon has one of the highest prevalences of mental illness in the nation, affecting one in every five adults. With the rise in promising results regarding the efficacy of psilocybin for mental health conditions, Oregon became the first state in the US to approve of legalised psilocybin under Oregon’s Psilocybin Services Act – “Measure 109” – in November 2020.

Measure 109 aims to develop a “long-term strategic plan for ensuring that psilocybin services will become and remain a safe, accessible and affordable therapeutic option for all persons 21 years of age…” and “establish a comprehensive regulatory framework concerning psilocybin products and psilocybin services under state law…” among other actions.

In a meeting with the OPAB, Dennis presented a set of draft regulations that would grant religious protections under Oregon’s new psilocybin law.

See also  Global coalition launches to push for psilocybin rescheduling 

Addressing the board, Dennis cited the words of medicine woman Maria Sabina, whose sacred ceremonies in Mexico were based on the use of psilocybin. When the news of her ceremonies broke in The Times, Westerners flocked to Mexico in order to experience the mushrooms. This led to restrictions from the Mexican Government on their ritual use.

“Never, as far as I remember, were the saint children [the mushrooms] eaten with such lack of respect,” Sabina had commented – saying that foreign visitors ruined the purity of the mushrooms.

Dennis commented: “When we think about what Oregon is doing right now with this new psychedelic programme, we have to consider this history – part of this history is the emergence of the psychedelics industrial complex. This is the list of companies that are publicly traded.

“Keep in mind – with about $4.8bn in market cap – non of this is really legal yet. I don’t suppose that all of these companies are engaging in aggressive tactics – but we are already starting to see the intellectual property grabs and the land grabs, to corner out other types of access to psychedelic healing modalities that exist. 

“If we as a society are to protect religious use the best way to do that is to do it now. Because as these companies get bigger and bigger and become more aggressive, and try to corner out other types of psychedelic healing and psychedelic use, it is not going to get easier as this psychedelic complex gets more entrenched.”

Concerns were also raised regarding lobbyists meddling in Oregon’s psilocybin programme.

Protections for entheogenic practitioners

Many people across the world use entheogens – psychoactive plants or substances that are used in a sacred or spiritual manner.

To reflect this use of psychoactive plants, within Dennis’ draft framework, the word “entheogenic” is used rather than “religious” to ensure that those who use these plants as part of any practice related to their sincere beliefs have their rights maintained. 

See also  Could Italy decriminalise psychotropic substance cultivation? 

Dennis proposed a partnership between the Oregon Health Authority and entheogenic practitioners that he believes would be beneficial to all parties, by bringing entheogenic practice out of the underground to “above ground”. This would provide oversight and accountability, ensuring that people are going through a screening process and safeguards are in place. It will also ensure practitioners will not have to face the risk of jail for practices related to their beliefs.

“This also helps with the tension inherent in Measure 109 around accessibility and affordability,” said Dennis. “I believe, particularly with the peer support model and homegrown mushroom model, that we can drive the price point down to something that is actually affordable.

“This cause is too important for it to be another vehicle to reinforce or deepen inequalities that exist along racial, health or financial mechanisms – it is going to be such a tragic thing as we enter into this new era where we re-establish relationships with plant medicines – it is critical we give small community-led organisations their own means of production and do something to protect that.”

Click here to read the draft framework

Community-based healing

Bob Otis Stanley, pastor and chief garden steward of Oakland-based church, the Sacred Garden Community, which uses psychedelic plants as part of their religious ritual, also highlighted the importance of community-based healing.

Stanley commented: “We have a common faith in our church that the sacraments of our church are approached with care, respect and trust and can connect us with experience of divine presence within this lifetime. 

“But we can accept many incoming faiths – atheism, Christian, Jewish, Islam, Pagan. So, we are trying to create a strong container for the diversity that we find here in Oakland, but also who have a sincerely shared faith. 

“By trying to create this community framework that has deliberate harm reduction built-in we are recreating some of the benefits in long term culture that I have experienced in the many years visiting the Sierra Mazateca region. Each little village and valley that will have one or two, or several, curanderos [healers] will have culture integrated with that healing process – we are lacking here in the United States. 

“So to have an intentionally created community that can provide some of that support for the frameworks you may find in other traditional cultures is part of our goal.”

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Mapping the effects of ketamine on the brain



Mapping the effects of ketamine on the brain

A new study has mapped the effects of ketamine on the brain, finding that repeated use over extended periods creates widespread structural changes in the brain’s dopamine system.

The study found that repeated ketamine exposure leads to a decrease in dopamine neurons in midbrain regions linked to regulating mood. They also revealed an increase in dopamine neurons in the hypothalamus, which regulates the body’s basic functions like metabolism and homeostasis.

A former finding that ketamine decreases dopamine in the midbrain, may indicate why long-term abuse of ketamine could cause users to exhibit similar symptoms to people with schizophrenia. 

The researchers suggest that their new finding that ketamine increases dopamine in the parts of the brain that regulate metabolism, published in Cell Reports, may help explain why it shows promise in treating eating disorders.

They suggest this strengthens the case for developing ketamine therapies that target specific areas of the brain, rather than administering doses that wash the entire brain in ketamine.

Raju Tomer, the senior author of the paper, stated: “Instead of bathing the entire brain in ketamine, as most therapies now do, our whole-brain mapping data indicates that a safer approach would be to target specific parts of the brain with it, so as to minimise unintended effects on other dopamine regions of the brain.”

Tracking detailed data

The researchers tracked highly detailed data that enabled them to track how ketamine affects dopamine networks across the brain. 

The insight revealed that ketamine reduced the density of dopamine axons (nerve fibers) in the areas of the brain responsible for hearing and vision, while increasing dopamine axons in the brain’s cognitive centers, which may help explain the dissociative behavioral effects observed in individuals exposed to ketamine.

Malika Datta, a co-author of the paper, added: “The restructuring of the brain’s dopamine system that we see after repeated ketamine use may be linked to cognitive behavioral changes over time.”

Most studies of ketamine’s effects on the brain to-date have looked at the effects of acute exposure – how one dose affects the brain in the immediate term. 

For this study, researchers examined repeated daily exposure over the course of up to ten days. Statistically significant alterations to the brain’s dopamine makeup were only measurably detectable after ten days of daily ketamine use. 

The researchers also assessed the effects of repeated exposure to the drug at two doses, one dose analogous to the dose used to model depression treatment in mice, and another closer to the dose that induces anesthesia. The drug’s effects on dopamine system were visible at both doses.

“The study is charting a new technological frontier in how to conduct high-resolution studies of the entire brain,” said Yannan Chen, paper co-author. 

It is the first successful attempt to map changes induced by chronic ketamine exposure at what is known as “sub-cellular resolution,” in other words, down to the level of seeing ketamine’s effects on parts of individual cells.

Most sub-cellular studies of ketamine’s effects conducted to date have been hypothesis-driven investigations of one area of the brain that researchers have targeted because they believed that it might play an important role in how the brain metabolises the drug. 

This study is the first sub-cellular study to examine the entire brain without first forming such a hypothesis.

Bradley Miller, a Columbia psychiatrist and neuroscientist who focuses on depression, said: “Ketamine rapidly resolves depression in many patients with treatment-resistant depression, and it is being investigated for longer-term use to prevent the relapse of depression. 

“This study reveals how ketamine rewires the brain with repeated use. This is an essential step for developing targeted treatments that effectively treat depression without some of the unwanted side effects of ketamine.”

“This study gives us a deeper brain-wide perspective of how ketamine functions that we hope will contribute to improved uses of this highly promising drug in various clinical settings as well as help minimise its recreational abuse. More broadly, the study demonstrates that the same type of neurons located in different brain regions can be affected differently by the same drug,” added Tomer.

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Psychedelic therapy programmes launch to address heartbreak, burnout and more



Psychedelic therapy programmes launch to address heartbreak, burnout and more

Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges. 

Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.

All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.

See also  Psychedelics for frontline workers, palliative care and eating disorders

The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.

Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.

Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.

“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”

“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.

“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”

Additional Mastermind programmes will be released in the coming months, including: Getting Unstuck, by Dr Elizabeth Lombardo; Beating Burnout, by Dr Shauna Shapiro; and Coping with Cravings, by Dr Jud Brewer

“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.

“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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