Frequently Asked Questions · Mind Medicine Australia
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Frequently Asked Questions

Mind Medicine Australia is a registered charity (DGR-1 status) working to develop evidence-based and regulated psychedelic-assisted treatments for mental illness in Australia. We act as a nexus between clinicians, academia, government, regulators, philanthropists, and patients, working in close consultation and partnership with relevant experts and organisations. Our focus includes awareness and knowledge building through education, events, webinars and community chapters. We provide a professional development program, including the world-leading Certificate in Psychedelic-Assisted Therapies (CPAT)™ along with other workshops and courses. We support university research, education, funding, and development of clinical trials. We also support patient access, affordable medicine supplies and the development of clinics.

Mind Medicine Australia is focused specifically on the clinical application of psilocybin and MDMA for certain mental illnesses.

Mind Medicine Australia was established to support research into and enhance the effectiveness and safety of, psychedelic-assisted psychotherapies, while reducing unnecessary delays in implementing this approach within Australia. One in four Australians are currently suffering from a mental illness and one in seven are on antidepressants. One in two Australians will be affected by a mental illness in their lifetime. Australia is experiencing a growing mental health crisis that current treatment options are unable to adequately address. While available mental health treatments can be effective, the majority of patients do not go into remission. Therefore, we need to support the most effective and innovative treatments to address these cases.

Over the past decade, psilocybin and MDMA-assisted psychotherapies have demonstrated remarkably promising clinical results in overseas trials. Mind Medicine Australia is leading the way and developing a viable ecosystem in this rapidly emerging field. Through our efforts, the Therapeutic Goods Administration (TGA) rescheduled Psilocybin and MDMA as Controlled Medicines on February 3 2023 [1], making us the first nation in the world to do. Read more about the state of mental health here.

 

[1] TGA. (2022). Notice of final decision to amend or not amend the current poisons standard: June 2022 (ACMS-38). Retrieved from https://www.tga.gov.au/sites/default/files/2023-02/notice-of-final-decision-to-amend-or-not-amend-the-current-poisons-standard-june-2022-acms-38-psilocybine-and-mdma.pdf

Mind Medicine Australia acts as a nexus between clinicians, academia, government, regulators, philanthropists, and patients, working in close consultation and partnership with relevant experts and organisations. Our focus includes awareness and knowledge building through education, events, webinars and community chapters. We provide a professional development program, including the world-leading Certificate in Psychedelic-Assisted Therapies (CPAT)™ along with other workshops and courses. We support university research, education, funding, and development of clinical trials. We also support patient access, affordable medicine supplies and the development of clinics.

Knowledge, training, and certification is essential to ensure best practice for psychedelic-assisted psychotherapies. The Certificate in Psychedelic-Assisted Therapies (CPAT)™ by Mind Medicine Australia (MMA) is a part online and part face-to-face professional training that provides registered healthcare professionals with the knowledge and skills to safely and effectively administer psychedelic-assisted therapies (PAT) in clinical settings. The training is delivered by a world-class Faculty made up of global leaders in the field. It teaches best practice for the delivery of PAT, with a focus on psilocybin, MDMA and ketamine-assisted therapy. These are the three psychedelic medicines with regulatory approval in Australia. Learn more about the CPAT™ and apply here.

Mind Medicine Australia supports research that investigates the benefits, mechanisms, and risks of psychedelic-assisted psychotherapies. We are particularly interested in novel research protocols that expand on research conducted by major universities overseas, and that seek to answer key questions to enhance clinical effectiveness and safety.

We advocate for evidence-based policy that supports research and appropriate service provision for the therapeutic use of psychedelics alongside psychotherapy. Mind Medicine Australia is specifically focused on the clinical application of psilocybin and MDMA for certain mental illnesses. Our primary focus is the support of policies and practices that will result in substantial improvement in mental health treatment outcomes for Australians (remission & response rates). Mind Medicine Australia advocates for policies that ensure that psychedelic-assisted psychotherapies can be accessible and affordable to all Australians in need.

We are a small organisation doing big things. We rely on support from our partners and the community. Please support MMA and this rapidly emerging field through the following actions:

  1. Spread the word to your friends, colleagues and networks about the potential of Psychedelic-Assisted Therapies.
  2. Share our 2-minute Animation about psychedelic-assisted therapies far and wide!
  3. Download important documents about the state of mental health in Australia and Mind Medicine Australia HERE including our 2-page Mind Medicine Australia fact sheet and our Frequently Asked Questions.
  4. Submit your application for our Certificate in Psychedelic-Assisted Therapies.
  5. Complete the Fundamentals in PAT Online course.
  6. Keep up to date with the latest news about Psychedelic Medicine by accessing information from Mind Medicine’s website and subscribing to our regular newsletter, click HERE and scroll down to subscribe.
  7. See the progress we have made in Mind Medicine Australia’s Annual Reviews.
  8. Register for and attend our Global Webinar Series.
  9. Subscribe and listen to the Mind Medicine Australia Podcast series.
  10. Donate to Mind Medicine Australia to support Patient Access, Psychedelic Research, Public Education and Financial Assistance for Therapist Training
  11. Join our Chapters and advocacy network around Australia and NZ.
  12. Purchase the first Australian book of true healing stories which reinforces the life-changing and life-saving impact of psychedelic-assisted therapies for a range of mental illnesses and addictions.
  13. Purchase our range of unique merchandise and show your support.
  14. Volunteer to work with Mind Medicine Australia. We are a small organisation doing big things. If you feel you have the skills and time to lend us a hand, please get in touch.

Psychedelics are chemical compounds which temporarily create changes in brain function including shifts in perception, thinking, and feeling, producing an ‘altered state of consciousness’. The ‘classical psychedelics’ include substances like psilocybin (found in a variety of mushrooms), ayahuasca, mescaline, lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT). Although not a classical psychedelic, MDMA is often included in this category due to some similarities in its effects and clinical applications. Classical psychedelics appear to produce many of their effects through the activation of a specific Serotonin receptor (5HT2A) in the brain. The word psychedelic, coined by British psychiatrist Humphry Osmond, means ‘mind revealing’.

Psychedelic-assisted therapies involves certain approaches to ‘talk-therapy’ alongside the ingestion of a psychedelic compound such as psilocybin, or MDMA. Researchers and clinicians often describe three distinct therapy phases that take place over several days: preparation, the psychedelic experience, and integration. Importantly, the non-psychedelic elements of this approach are essential for both effectiveness and safety.

Historians and anthropologists have found that psychedelic agents have been utilised for thousands of years and in various contexts, from the medicinal to the ritualistic. The historical use of psychedelics in the West traces back to Ancient Greece’s Eleusinian Mysteries, a ritualised initiation rite involving what anthropologists believe was a psychedelic drink. MDMA was first synthesised in 1912 by the German pharmaceutical company Merck, and LSD was first synthesised in 1938 by the Swiss chemist Albert Hofmann at Sandoz Laboratories. Sandoz also isolated psilocybin for the first time in 1957.

In the 1950s, psychedelic-assisted psychotherapy was regarded by a proportion of psychiatry as the next big breakthrough for treating mental illness, and was used for a range of conditions in tens of thousands of patients. Thousands of research papers were published on psychedelic therapy between 1950-1972. These documented their application as treatments for depression, anxiety, post-traumatic stress disorder (PTSD), and alcohol dependence.

How did they get such a bad name? Psychedelics were scheduled for predominantly political reasons. These centred on former US President Nixon’s ‘War on Drugs’, which was used to suppress the anti-Vietnam war movement. Before the recent rescheduling to Schedule 8, psilocybin and MDMA were Schedule 9 drugs in Australia (Schedule 1 in the USA). This category is reserved for substances considered by regulators to be without medical value, and with high abuse potential. Extensive research has shown that psychedelics do not meet either of these criteria.

In addition to unjustified scheduling that has had a global impact through various international treaties, government funding and ethics committee support for research was completely stopped. Given that psychedelic-assisted psychotherapy was establishing itself through the 1950s and 1960s as the ‘next big thing’ in psychiatry, this censoring of inquiry into such a promising line of research is unprecedented in the modern world. Former US officials within the Nixon administration have since admitted that their scheduling of psychedelics and certain other compounds was an attempt to suppress parts of society that posed a challenge to their worldview and political agenda.

Internationally, there has been a resurgence of research into psychedelics at universities such as Harvard, Johns Hopkins, New York University, Stanford, Imperial College London, and the University of Zurich. Hundreds of well-controlled clinical trials have yielded promising results. The new data confirms that psychedelic-assisted psychotherapies frequently lead to remission from certain mental illnesses within a few doses, when administered with proper psychotherapeutic support before, during and after treatments. The proportion of participants who show positive clinical improvements, and the degree to which they improve, are substantially higher than clinical outcomes associated with currently available treatments. Psilocybin-assisted therapy can lead to remission in 60-80% of cases of anxiety and depression [1,2], whereas current existing treatments lead to remission in a maximum of 30-35% of cases. Read a literature review by our Scientific Officer here.

 

[1] Griffiths, R. R. et al. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of psychopharmacology, 30(12), 1181-1197.
[2] Ross et al. (2016). Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Journal of Psychopharmacology, 30-12:1165-1180.

A number of theories have been put forward to account for the therapeutic effects of psychedelics. The most prominent theories are based on recent brain imaging data. One way in which classical psychedelics may help with issues like depressive, addictive, and obsessive disorders is by allowing the brain and mind to ‘break out’ of repetitive and rigid styles of thinking, feeling, and behaving. Psychedelics temporarily alter activity and increase connectivity between novel neural networks within the brain, potentially breaking patients out of pathological patterns of thought and habit.

In a therapeutic setting, psychedelics frequently produce profound personal or existential insights, feelings of empathy and self-compassion, and a sense of connection or unity with other people, things, and the world in general. Research shows that these characteristics are correlated to therapeutic outcomes and that patients regard these experiences among the most meaningful of their lives [1]. In clinical settings, psychedelic-assisted-psychotherapy creates a fertile ground for change and for restoring patient agency.

 

[1] Kajonius, P., Sjöström, D., & Claesdotter-Knutsson, E. (2023). Reproducing the Psychedelic Experience:“One of the 5 Most Meaningful Experiences in Life”?.

Brain imaging studies have opened a window into the mechanisms of psychedelic-assisted therapies and the study of consciousness itself. Psychedelics reduce the activity of a ‘hub’ structure in the brain called the Default Mode Network (DMN) [1]. The DMN is associated with rumination about the past, daydreaming and autobiography – our ‘self-story’, which can become distorted and overactive in mental illness. By temporarily decreasing the activity of the DMN, psychedelics appear to enable communication among more diverse brain regions, and possibly facilitate an opportunity to break free from dysfunctional beliefs and mental ‘ruts’.

 

[1] Gattuso, J. J., Perkins, D., Ruffell, S., Lawrence, A. J., Hoyer, D., Jacobson, L. H., … & Sarris, J. (2023). Default mode network modulation by psychedelics: a systematic review. International Journal of Neuropsychopharmacology, 26(3), 155-188.

MDMA is known for increasing feelings of trust and compassion whilst decreasing fear and defensiveness, which makes it easier for patients to be able to revisit their traumatic memories without debilitating anxiety, and to address them in various ways. MDMA-assisted therapy increases a sense of safety and self-compassion, whilst decreasing avoidance and defensiveness, allowing patients to revisit traumatic memories without triggering and experiencing re-traumatisation. MDMA has also been shown to decrease the reactivity of the amygdala, reducing the experience of fear (fight and flight) associated with traumatic memory, allowing the processing of adverse events in psychotherapy.

MDMA is not the same as “Ecstasy”. Substances sold on the street may contain MDMA, but frequently also contain unknown adulterants. In clinical studies, pure MDMA has been shown to be safe for human consumption when taken at therapeutic doses under professional supervision.

While psychedelics are powerful substances, and can produce challenging experiences without appropriate support, there is no evidence that psychedelic use is linked to either mental illness or negative health outcomes. A meta-analysis published in the premier journal Nature found no link between psychedelic use (not within a clinical context) and psychosis across a cohort of 135,000 people [1]. The researchers found that individuals who had taken psychedelics were not at increased risk of developing 11 indicators of mental-health problems, including: schizophrenia, psychosis, depression, anxiety disorders and suicide attempts. In addition, it was found that lifetime psychedelic use was associated with decreased suicide risk and improved wellbeing.

For patients with psychosis risk or other unstable personality issues, psychedelic-assisted psychotherapy may be ineffective or involve complications, and is not recommended – although further research is needed to determine the degree to which safety concerns are warranted. As a matter of caution, patients with these conditions are typically excluded from clinical trials of psychedelic-assisted psychotherapy.

 

[1] Johansen P-Ø, Krebs TS. Psychedelics not linked to mental health problems or suicidal behavior: A population study. Journal of Psychopharmacology. 2015;29(3):270-279. doi:10.1177/0269881114568039

So far, psilocybin-assisted psychotherapy has shown great promise in the treatment of depression, anxiety, end-of-life stress and addictions in well-controlled Phase 2 and 3 clinical trials, with some evidence for successfully treating Obsessive Compulsive Disorder and Eating Disorders. New trials are also underway for Dementia. MDMA-assisted psychotherapy has been successfully used to treat PTSD and addictions. Early clinical data also suggests an application for social anxiety in autistic adults.

Read more academic journals about psychedelic research here.

It has been suggested that psychedelics are most helpful in conditions characterised by rigid thoughts and behaviours such as depression, anxiety, addiction, OCD and eating disorders. They may also prove to be helpful with pain relief, immune function, cognitive function, cluster headaches, autism and learning disorders. Recently, the Psychedelic Research Centre at Imperial College has suggested investigating psychedelics for use in ‘disorders of consciousness’ including acquired brain injury, vegetative states, and minimally conscious states. MDMA was originally used in couples’ therapy and for conflict resolution, for which it offers great promise.

This is a hugely exciting field, with research to date showing very encouraging outcomes for patients, especially for those suffering with post-traumatic stress disorder, depression and anxiety and treatment resistant depression, end-of-life stress and addictions. The safety profile and strong effect sizes to date suggest that this could become an extremely important addition to our options for the treatment of severe and enduring maladies of the mind.

In February 2023 the TGA approved Mind Medicine Australia’s applications to reschedule psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard. With this rescheduling, psychiatrists who are given approval from the TGA are now able to prescribe psilocybin for treatment-resistant depression and MDMA for PTSD. These changes came into effect July 1st, 2023.

You can find out more about this exciting news in the TGA’s announcement and MMA’s media release here.

Psychiatrists who have undergone specialist training in psychedelic-assisted therapies can apply to become an Authorised Prescriber of psilocybin for treatment-resistant depression and MDMA for PTSD. To do so, they are required to make a submission to a Human Research Ethics Committee (HREC) that outlines details of their proposed approach including protocols, clinical rationale, training and more. Once approved by an Ethics Committee, they will then apply to the TGA for Authorised Prescriber status, which will allow them to prescribe and administer MDMA and psilocybin under the restrictions outlined above.

In February 2023 the TGA  approved Mind Medicine Australia’s application to reschedule psilocybin and MDMA from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines) of the Poisons Standard. With this rescheduling, psychiatrists who are given approval from the TGA are now be able to prescribe psilocybin for treatment-resistant depression and MDMA for PTSD. These changes came into effect July 1st, 2023.

You can find out more about it in the TGA’s announcement and MMA’s media release here.

Psychiatrists who have undergone specialist training in psychedelic-assisted therapies can apply to become an Authorised Prescriber of psilocybin for treatment-resistant depression and MDMA for PTSD. To do so, they’ll be required to make a submission to a Human Research Ethics Committee (HREC) that outlines details of their proposed approach including protocols, clinical rationale, training and more. Once approved by an ethics committee, they will then apply with the TGA for Authorised Prescriber status, which will allow them to prescribe and administer MDMA and psilocybin under the restrictions outlined above.

The TGA rescheduled MDMA and psilocybin in response the MMA’s rescheduling applications, submitted in March 2022.

This decision was a reversal from the TGA’s interim decision in September 2022, which opposed rescheduling.

The final decision noted the large number of public submissions, showing the incredible need for new treatment options, and a presentation made to the TGA in November by Professor David Nutt.

Watch the presentation from Professor Nutt with MMA founders Tania de Jong AM and Peter Hunt AM below for details of how it happened.

If you have a diagnosis of treatment-resistant depression or PTSD and you are interested in learning more about your options for treatment with psychedelic-assisted therapies, please speak to your treating physician. If you would like to be sent information regarding updates on accessibility, please fill out our EOI form.

You can direct your doctor to contact Mind Medicine Australia. We will provide them with further information so they understand the current landscape in Australia and can help you effectively.

If you are interested in being involved in clinical trials, we have listed all upcoming trials in Australia and New Zealand here. If you meet the eligibility requirements for any of these, follow the directions on the page to contact the group running the specific trial you are interested in for further information on participating.

If you, or someone you know, is in need of additional support, please call 000 or any of the crisis support helplines listed below:

SANE Australia (for people living with a mental illness) – call 1800 187 263.
beyondblue (for anyone feeling depressed or anxious) – call 1300 22 4636 or chat online.
Lifeline (for anyone having a personal crisis) – call 13 11 14 or chat online.
Suicide Call Back Service (for anyone thinking about suicide) – call 1300 659 467.
Australian Government/Department of Health ‘Head to Health’ webpage is a central platform for digital mental health resources.

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