Announcing a Major Healthy Persons Trial to Investigate the Brain Activity Effects of Psychedelic Medicines

There is strong evidence to support the safety and clinical effectiveness of psilocybin assisted psychotherapy for depression and MDMA assisted psychotherapy for post-traumatic stress disorder (PTSD) when used in medically controlled environments. Innovation in the mental health sector is critical because current treatments are not working for a large number of patients and can cause adverse side effects for many patients.

According to the Productivity Commission 1 in 5 Australians had a mental illness before the current COVID pandemic. 1 in 8 Australians (including 1 in 4 older people) were on antidepressants (an increase of 95 % over 15 years). As a result of the pandemic these numbers are now expected to be significantly worse. There is an urgent need for treatment innovation to reduce suffering.

Mind Medicine Australia (MMA) is therefore delighted to announce that it is part-funding a clinical trial which has just received Human Research Ethics approval and is designed to study the brain activity of participants after taking psychedelic medicines. One arm of the study will involve exposure to a single medical dose of 3,4 methylenedioxymethamphetamine (MDMA) and the other arm will involve exposure to a single medical dose of psilocybin. The clinical trial is expected to commence later this year with up to 200 participants (involving 100 participants for each of the study arms).

The clinical trial is being sponsored by Monarch Mental Health. The Principal Investigators for the trial are Dr Neil Bailey and Professor Paul Fitzgerald. The lead therapists for the trial will be Counselling Psychologist Mr Nigel Denning and psychotherapist Dr Tra-ill Dowie from the Mind Medicine Institute.

Participants in the trial must have successfully completed training in the administration of psychedelic assisted therapy, primarily through the Mind Medicine Institute’s Certificate in Psychedelic-Assisted Therapies course (see https://cpat.mindmedicineaustralia.org/). Participants will experience the medicines in small groups supported by therapists and a medical practitioner.

The primary purpose of the project is to determine whether there are any changes in brain activity (as measured by electroencephalography – EEG) following exposure to either medical grade MDMA or medical grade psilocybin. A secondary aim of the trial is to assess potential changes in mood, personality, beliefs and social engagement following exposure to these substances that might relate to neural changes.

According to Professor Paul Fitzgerald, “The results of this study will inform us as to whether these substances have an effect on brain activity related to cognitive and emotional processes which continues after the medicine session and may also provide information that can help explain how these substances have their clinical effects”.

According to lead therapist and psychologist, Mr Nigel Denning, “The initiative for a healthy persons trial supported by Mind Medicine Australia provides an incredible opportunity to ultimately bring a completely new form of psychotherapeutic treatment to people in need and open up a new paradigm in mental wellness. Given the strong ethical and scientific emphasis shown in the study it will provide hope for many people and provide a whole new opening in scientific exploration of the mind, brain and mental health. It is with great pride that Dr. Tra-ill Dowie and I have the privilege of both participating in this study and supporting the development of therapists through the Mind Medicine Institute and our Certificate in Psychedelic-Assisted Therapy, a world leading training program.”

All participants will be extensively screened to ensure that they have no contraindications or risk factors that could prevent their participation in the trial. The project will be carried out according to the National Statement on Ethical Conduct in Human Research (2018), produced by the National Health and Medical Research Council (NHMRC) of Australia. Similar projects have received approval in Canada (https://psilocybinalpha.com/news/17-canadian-healthcare-professionals-approved-to-use-psilocybin-for-professional-training) and in the United States (https://maps.org/news/media/maps-wins-appeal-and-authorization-to-study-mdma-in-healthy-volunteer-therapists/).

The Chairman of MMA, Mr Peter Hunt AM, saId: “We are delighted to support this innovative trial that seeks to expand our knowledge of how medical grade MDMA and medical grade psilocybin work in the brain in a controlled environment when used as part of clinical treatment.”

The Executive Director of MMA, Ms Tania de Jong AM, said: “There is a desperate need for innovation in the mental health sector and these treatments have achieved outstanding results in overseas trials after just two to three sessions in combination with a short course of psychotherapy. We now have the potential to help people suffering from major classes of mental illness such as depression, post- traumatic stress disorder and potentially anorexia and other eating disorders, OCD, dementia and a range of addictions.”