Summary: Australia may be the next country to conduct research into treating PTSD with MDMA-assisted psychotherapy, according to Isolated Nation’s interview with Dr. Stephen Bright of Psychedelic Research in Science and Medicine (PRISM). “If we can demonstrate that we have the people and infrastructure then they have suggested that we might be able to be one of the sites in this international multi-site Phase 3 trial,” explains Dr. Bright.
Originally appearing here.
Curious about how mental health issues may be treated in the future?
Dr. Stephen Bright, a West Australia-based Alcohol and Other Drugs researcher and Vice President of Psychedelic Research in Science and Medicine (PRISM) has received funding from Edith Cowan University for a feasibility trial of MDMA-assisted psychotherapy for people with treatment-resistant post-traumatic stress disorder (PTSD). PTSD is a serious, long-lasting, and life-threatening condition when not adequately treated, highlighting the need for new therapies.
If Dr. Bright can show that Perth has the people and infrastructure, Western Australia could be one of the international sites in a Multidisciplinary Association for Psychedelic Studies (MAPS) Phase 3 trial. This is the last trial stage before a drug or medicine can be prescribed to patients.
The following short podcast was made with the assistance of Australian Science Communicators (ASC) WA branch as a part of National Science Week 2018.
Approximately two-thirds of people will experience a potentially traumatic event in their lifetime, and currently 1.4 million Australians are living with post-traumatic stress disorder, a debilitating mental illness. Soon, people with PTSD may be treated using a pre-existing drug with an unconventional history.
Originally synthesised in 1912, MDMA became popular in the 1980s dance scene, inducing feelings of euphoria and emotional openness in its users. Under Ronald Reagan, MDMA was classified as a Schedule 1 drug in the US and it’s only now, three decades later, that research into MDMA-assisted psychotherapy as a treatment for PTSD is being slowly revisited with Phase 2 clinical trials conducted in the US, Switzerland and Israel.
In Australia, regulators are still uneasy, but researchers are working hard to ensure future Australians will have access to effective PTSD treatment. Today, we’re speaking to one of those researchers:
Dr. Stephen Bright: Hi, my name’s Dr. Stephen Bright I am a Senior Lecturer in Addiction at Edith Cowan University and I am also Vice President of Psychedelic Research in Science and Medicine (PRISM), Australia’s first not-for-profit organisation which aims to initiate and fund research into the beneficial effects of psychedelic drugs.
Isolated Nation: So, when MDMA was defined as a Schedule 1 drug in the US, were researchers already aware of its potential medical uses?
Dr. Bright: Absolutely, when MDMA was scheduled in 1986 there a was a trial that was conducted to assess whether it had medical utility and indeed the judge ruled that it did have medical utility, but unfortunately the Drug Enforcement Agency was concerned about the recreational use of it and placed it in Schedule 1, meaning it has no medical utility and it has high abuse potential.
Tell us about this upcoming feasibility trial.
Would phase 2 trials have to be conducted in Australia before we can participate in these Phase 3 trials?
Dr. Bright: No, so MAPS have already conducted Phase 2 clinical trials, they’ve conducted 6 trials to date that have demonstrated the efficacy of MDMA-assisted psychotherapy for treatment-refractory (treatment-resistant) PTSD. In fact, 66% of people that were given MDMA no longer met criteria for PTSD at 12-month follow-up. This has allowed the FDA, the Food and Drug Administration in the US, to grant MAPS with permission to go ahead with Phase 3 trials. They have given it ‘Breakthrough’ designation because the effect size was so strong that they only need a small number of participants, unlike a normal clinical trial of a medicinal drug. In addition to that, they have a Compassionate Access Scheme because the FDA believed this is such a good therapy that people should be able to access it, even if they can’t be involved in the research, but you do need to be a US citizen.
Dr. Stephen Bright, thank you so much for your time today. We look forward to the results and the implications of your upcoming feasibility trials, thank you again for your time.
Dr. Bright : No worries mate, good luck! Bye!