Psychedelics

Changes for Psilocybin and MDMA in Australia

Published

2 years ago

February 15, 2023

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The Therapeutic Goods Administration (TGA) has announced that Psilocybin and MDMA will be able to be prescribed by specially qualified psychiatrists for the treatment of particular mental health issues as of July 1, 2023.

This is a big deal! As Dr Stephen Bright points out, ‘This decision makes Australia the first country in the world to recognise MDMA and Psilocybin as medicines.’ This means people who would benefit from these therapies have a chance at accessing them through legal channels.

Read on to learn the facts of the TGA decision as well as the implications for patients and people who use psilocybin and MDMA in non-clinical settings.

Re-scheduling of psilocybin and MDMA in the Poisons Standard

Psilocybin and MDMA (3,4-methylenedioxy-methamphetamine)-containing medications can now be prescribed by specially qualified psychiatrists for the treatment of particular mental health issues as of July 1, 2023.

The TGA decision means that psilocybin and MDMA will be added to Schedule 8 (S8), permitting their use as Controlled Drugs. Psilocybin will be permitted only for treatment-resistant depression (TRD). MDMA will be permitted only for post-traumatic stress disorder (PTSD).

Psilocybin and MDMA will only be allowed to be prescribed by specialist psychiatrists under the following conditions: they must have approval from a Human Research Ethics Committee (HREC), and they must be authorised by the TGA under the Authorised Prescriber Scheme to prescribe the substances for these conditions.

The substances will also be available for approved clinical trials on treatment-resistant depression and PTSD.

The TGA states that psilocybin and MDMA are generally safe when used in a controlled environment under the supervision of properly qualified healthcare experts and in the dosages that have been studied in clinical trials. However, they also expressed a concern for patient vulnerability during the experience. Due to this, they determined that only psychiatrists who have been authorised under the Authorised Prescriber Scheme and are able to convince a Human Ethics Research Committee as well as the TGA that robust safety measures are in place to ensure patient safety should be eligible to prescribe.

Unauthorised possession of Psilocybin and MDMA as Schedule 8 drugs will remain illegal. Schedule 9 will be updated to keep current restrictions on all other uses of psilocybin and MDMA as prohibited substances. Due to their classification in state and territory legislation as drugs of dependence, dangerous drugs, or prohibited drugs, even though they are included in Schedule 8 of the Poisons Standard, the supply, use, or possession of psilocybin and MDMA may be illegal in some states and territories.

What This Means For Patient Access

Gaining access to psychiatrists is not easy, even for conventional treatments. In Victoria last year, patients were waiting up to six months to see a psychiatrist. Access for rural and regional patients remains difficult.

The Authorised Prescriber Scheme that psychiatrists need to go through to prescribe psilocybin or MDMA involves approval from both a human research ethics committee, and the TGA. We do not know how long this approval might take. But it’s safe to infer that for the next few years at least, very few psychiatrists will have gone through this process. So, there will not be many approved prescribers. Wait times could be much longer than for the average psychiatrist, though we would expect prescribers to prioritise patients with the greatest need.

In all likelihood, this will not be cheap either, particularly as psilocybin and MDMA are not on the PBS and are unlikely to be covered by any form of health insurance. Private psychiatric services are not well-funded by Medicare, and can cost up to $600 per hour.

We also note, as PRISM has expressed, that there are relatively few psychiatrists with specific training in psychedelic or MDMA-assisted therapy.

Finally, as the TGA has pointed out, it may be the case in some states that laws need to change to permit approved prescription of psilocybin or MDMA. This is likely the case in NSW, and we are assessing the impact in other states.

We flagged all of these potential issues when discussing potential rescheduling in May last year, and our expectations have not changed.

What This Means For Non-Clinical Use

In case it wasn’t obvious already, this does not mean that use, possession, growing or selling MDMA or psilocybin (in any form) are any less illegal than they were before. Telling the police that your bag of freshly picked shrooms or those couple of pingas in your pocket at a music festival are prescription medications is not going to get you out of trouble! Breaking the law remains a key risk associated with both of these substances. These changes do nothing to address this risk. The Australian Psychedelic Society remains committed to decriminalisation and related reforms to remove the criminal penalties for possession and use of illicit drugs and working towards safer supply.

We hope that the rescheduling will lead to a reduction in the stigma associated with these substances, and increased recognition of their potential benefits in both the general community and medical profession. But this also comes with the potential pitfall of psychedelics becoming something that psychiatry gets to play gatekeeper with. We do not feel that this would be an acceptable outcome.

Increases in community awareness of psychedelics bring their own complications, particularly when the medicines themselves are so hard to access legally. This decision makes education and harm-reduction work more important than ever before.

What Now?

The War on Drugs in Australia is not over. At best, it will be possible for those who would benefit from psilocybin or MDMA-assisted therapy to be able to access it without breaking the law. But this access will initially be slow and expensive.

Nonetheless, it’s a significant milestone to see our notoriously conservative national regulator recognise the therapeutic potential of these substances. It’s also noteworthy that the TGA is aware of the vulnerability of people during psychedelic experiences.

Even with this tiny step towards therapeutic access, many risks and much work remains. Maybe it’s too soon to be optimistic. But it feels like the right time to keep pushing hard for change that goes beyond the psychiatric profession, and gives us back a little more choice about what we put in our bodies and which experiences we have. If you’re interested in contributing to this, all you have to do is reach out – we need all the help we can get!

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colorado

First Psychedelic Church for Magic Mushrooms

Published

5 days ago

September 3, 2024

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Colorado Springs has recently become home to Colorado’s first psychedelic church dedicated to the use of magic mushrooms. The church, officially named the Sacred Tribe, represents a significant milestone in the broader acceptance and exploration of psychedelics within spiritual and religious practices. This development follows the state’s progressive stance on psychedelics, particularly after the passing of Proposition 122, which decriminalized the possession and use of certain natural psychedelics, including psilocybin, the active compound in magic mushrooms.

The Sacred Tribe: A New Frontier in Spiritual Practice

The Sacred Tribe was founded with the belief that psychedelics, particularly psilocybin, can play a vital role in spiritual awakening and personal growth. The church aims to provide a safe and supportive environment where members can use magic mushrooms as a sacrament in their spiritual practices. The founders of the Sacred Tribe believe that these substances can help individuals achieve a deeper connection with themselves, others, and the universe, facilitating profound spiritual experiences and healing.

Legal and Ethical Considerations

The opening of the Sacred Tribe raises important legal and ethical questions, particularly in the context of the United States’ complex relationship with psychedelics. While Proposition 122 decriminalized the personal use of psilocybin in Colorado, the establishment of a church centered around its use pushes the boundaries of current legal frameworks. The church operates under the protection of religious freedom, but it remains to be seen how this will be interpreted and enforced by state and federal authorities.

The Role of Psilocybin in Religious and Spiritual Contexts

Psilocybin, the psychoactive compound in magic mushrooms, has been used for centuries in various indigenous cultures for religious and spiritual purposes. The Sacred Tribe seeks to integrate these ancient practices into modern spiritual life, offering ceremonies and rituals designed to guide members through their psychedelic experiences. These practices are intended to help individuals explore their consciousness, heal from past traumas, and find meaning and purpose in their lives.

Community and Education at the Sacred Tribe

In addition to its religious ceremonies, the Sacred Tribe places a strong emphasis on community building and education. The church offers workshops, seminars, and group discussions on the safe and effective use of psychedelics, the history of their use in various cultures, and the potential benefits and risks associated with their consumption. By fostering a community of like-minded individuals, the Sacred Tribe hopes to reduce the stigma surrounding psychedelics and promote their responsible use.

Implications for the Future of Psychedelics in Colorado

The establishment of the Sacred Tribe is a significant development in the ongoing conversation about psychedelics in the United States. As the first psychedelic church in Colorado, it could set a precedent for similar organizations across the state and potentially the country. The church’s success or challenges could influence future legislation and public opinion on the use of psychedelics in both religious and therapeutic contexts.

Conclusion

The opening of Colorado’s first psychedelic church, the Sacred Tribe, marks a new chapter in the relationship between psychedelics and spirituality. As the church begins its journey, it stands as a testament to the growing acceptance of psychedelics as tools for spiritual and personal growth. How this development will shape the future of psychedelic use in Colorado and beyond remains to be seen, but it undoubtedly represents a significant step forward in the broader psychedelic movement.

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Environmental Conservation

Who Wants Free LSD Island Goats?

Published

6 days ago

September 2, 2024

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Gorgona, an Italian island known for its historical connection to LSD research, is currently facing an unusual problem: an overpopulation of goats. In a bid to manage the growing number of goats, local authorities have decided to offer them for free to anyone willing to take them. This initiative, while solving a practical issue, also highlights Gorgona’s unique LSD history and the environmental challenges it now faces. As a result, this is your once in a life time opportunity, to get a free LSD Islad goat, whatever that means…

The Historical Connection to LSD

Gorgona, often referred to as “Italy’s LSD Island,” earned its nickname due to its association with Albert Hofmann, the Swiss chemist who first synthesized LSD. Hofmann’s early experiments with ergot alkaloids, which led to the discovery of LSD, were conducted on Gorgona. Though the island’s connection to LSD is more of historical interest today, it adds a layer of intrigue to the current situation involving the goats.

Why Free LSD Island Goats?

The goat population on Gorgona has surged dramatically following the closure of the island’s prison, which once managed the livestock as part of inmate rehabilitation programs (point to think about – LSD and prison…). With no active management, the goats have overgrazed the island, threatening its delicate ecosystem. This environmental degradation prompted local authorities to offer the goats for free, aiming to reduce their numbers and restore ecological balance.

A Creative Solution to a Growing Problem

The decision to give away goats for free is an innovative response to the overpopulation crisis. This initiative not only helps control the goat population but also involves the public in wildlife management efforts. Those who adopt the goats will play a role in preserving Gorgona’s environment, which is critical for maintaining the island’s biodiversity .

Implications for Conservation and Wildlife Management

The goat giveaway is part of broader conservation efforts on Gorgona. By reducing the goat population, authorities hope to prevent further damage to the island’s vegetation and support the regeneration of native plant species. Conservationists are closely monitoring the situation to ensure that the island’s unique ecosystem is protected while addressing the practical needs of managing its wildlife.

Conclusion

Gorgona’s initiative to offer free goats reflects a practical solution to an environmental challenge, intertwined with the island’s rich LSD history. As the goats find new homes, the island will have a better chance of restoring its natural balance, preserving both its environment and its historical significance.

But focus on the impartance stuff: when was the last time you were offered free LSD? Even if it is only a goat…

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DEA Hearing

DEA Schedules 10-Day Hearing on Proposed Psychedelics Ban

Published

1 week ago

August 28, 2024

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The Drug Enforcement Administration (DEA) has scheduled a 10-day hearing to discuss the potential Psychedelics Ban of two psychedelic substances, 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC). This decision comes after increasing pressure from scientists, researchers, and advocates who argue that these compounds hold significant potential in treating mental health conditions and advancing scientific research. The hearing is set to begin on November 12, 2024, and will be crucial in determining whether these substances will be placed under Schedule I of the Controlled Substances Act.

What Are DOI and DOC?

DOI and DOC are psychedelic amphetamines known for their hallucinogenic properties. Both compounds are known to interact with serotonin receptors in the brain, particularly 5-HT2A, which is crucial for mood regulation. These psychedelics have been used in research settings to study their potential impact on conditions like depression, anxiety, and PTSD.

Despite their psychoactive properties, researchers argue that there is limited evidence of significant harm or high abuse potential associated with DOI and DOC. In fact, many scientists claim that these substances could be beneficial for advancing psychedelic therapy and exploring new treatments for mental health conditions. One report noted that while DOI and DOC do have hallucinogenic effects, there is little data to support claims of dependence or severe adverse health outcomes.

DEA’s Concerns and the Push for a Psychedelics Ban

The DEA initially proposed a ban on DOI and DOC in 2022, arguing that these substances pose a potential threat to public safety. The agency maintained that there is no recognized medical use for these psychedelics and cited concerns over high abuse potential. However, following significant pushback from the scientific community, the DEA postponed the decision and agreed to the upcoming 10-day hearing.

The DEA’s concerns primarily stem from anecdotal reports of hallucinogenic effects and one reported case where DOC was used in combination with other drugs, resulting in a death. However, critics point out that there is no strong scientific evidence directly linking these substances to widespread harm. Researchers have emphasized that placing DOI and DOC under Schedule I could severely hinder medical research on these compounds.

Why the Hearing Matters

This hearing represents a significant opportunity for researchers and advocates to present evidence supporting the continued legal use of DOI and DOC for scientific and medical purposes. Advocates argue that placing these substances under Schedule I would dramatically slow progress in the growing field of psychedelic-assisted therapy, which has already shown promising results in treating conditions like treatment-resistant depression, PTSD, and substance use disorders.

For many in the research community, the upcoming hearing offers a chance to underscore the importance of keeping DOI and DOC accessible for further scientific study. This is particularly relevant as the mental health crisis continues to grow globally, with millions suffering from conditions that current treatments fail to adequately address.

Conclusion: A Critical Moment for Psychedelic Research

The DEA’s decision to hold a 10-day hearing on the proposed ban of DOI and DOC is a critical step in the ongoing debate over how psychedelics should be regulated in the United States. While the agency remains cautious about the potential risks, the research community sees this as an opportunity to demonstrate the therapeutic potential of these substances. The outcome of this hearing could have far-reaching consequences, not only for psychedelic research but also for the future of mental health treatment.

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