A company exploring the efficacy of psychedelic treatments for PTSD in veterans has announced the international expansion of its Phase 2A clinical trials.
The Mydecine trials are exploring psilocybin-assisted psychotherapy to treat chronic post-traumatic stress disorder (PTSD) in veterans and Emergency Medical Services (EMS) personnel. The purpose of the trials is to explore how the brain responds to psychedelics and to develop a better understanding of the biological underpinnings created by the psychedelic experience.
The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia.
Mydecine hopes the trials will help to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting.
Chief Medical Officer, Dr Jetly, a prominent voice in the fight against PTSD and other mental health issues facing vulnerable populations like veterans and first responders, said: “The choice of working with veterans as our first subjects in our clinical trials was made for a variety of reasons. Along with my experience, and that of our Scientific Advisory Board, we have devoted our professional lives to the treatment of soldiers and veterans suffering from a variety of mental health conditions including PTSD.
“Those who have treated veterans and connected research in the same group have come to the realisation that, although many evidence-based treatments exist for PTSD, they are built largely on the ‘fear-based model,’ and sadly a significant proportion of those suffering do not respond positively. In fact, veterans tend to respond less often to the evidence-based therapies compared to other types of trauma.”
Psychedelic-assisted psychotherapy also allows for exploration of an important growing concept that appears to be particularly relevant in military populations known as ‘Moral Injury’.
Moral Injury describes persistent psychological difficulties that include guilt, shame, and anger that may become amplified when one perceives moral transgression of highly held values. It is hoped that after the psychedelic experience the internal reflection may allow therapists to influence these difficult-to-treat emotions.
Jetly added: “When we review the literature, we see psychedelics and psychotherapy being used effectively to treat a variety of conditions from depression and PTSD to chronic pain and addictions. When a treatment works in such varied conditions, we must wonder about a common underlying mechanism. We hope to study the brain and body via neuroimaging, electrophysiology and blood-based biomarkers in order to identify the key characteristics that lead to patients fundamentally changing to accept psychotherapy that they would not otherwise be receptive to.”
In addition to the sites in the Netherlands, Ontario, and Alberta, Mydecine is exploring additional trial sites across North America including Ottawa, Los Angeles, New York, and Boston.