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Changes for Psilocybin and MDMA in Australia



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




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




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




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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