Healthy persons trial to investigate the brain activity effects of psychedelics

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.

Mind Medicine Australia psychotherapy research

According to the Productivity Commission one in five Australians have experienced a mental health issue even before the beginning of the global COVID-19 pandemic.

1 in 8 Australians 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.

The study will involve exposure to a single dose of 3,4 methylenedioxymethamphetamine (MDMA) and another 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 with 100 participants for each of the study arms. The trial is 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 must complete training in the administration of psychedelic therapy, primarily through the Mind Medicine Institute’s Certificate in Psychedelic-Assisted Therapies course.

They will receive 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 following exposure to either medical grade MDMA or medical grade psilocybin.

Another 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.

Comments on Mind Medicine Australia’s research

“The results will inform us of how these substances have an effect on brain activity related to cognitive and emotional processes which continues after the medicine session.”

“It will help in facilitating us to provide information that can help explain how these substances have their clinical effects,” Prof. Fitzgerald said.

The lead therapist and psychologist of the project, Mr Nigel Denning is buoyant.

“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.”

“Strong ethical and scientific emphasis shown in the study will provide hope for many and provide a 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 follow 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 and in the United States.

The Chairman of MMA, Mr Peter Hunt AM said, “We are delighted to support this 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 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.”