By Javier Hasse
Published on Forbes.com, Aug. 12, 2020
Psychedelics-based treatments developer NeuroPharm Inc., a subsidiary of publicly traded Mydecine Innovations Group Inc., recently announced it would be collaborating with the Leiden University Medical Center of The Netherlands (LUMC) on clinical trials for the treatment of posttraumatic stress disorder (PTSD) in veterans.
The project involves the preparation of an IRB-ready protocol that will later be utilized in the LUMC-based clinical trial. The ARQ National Psychotrauma Centre will also be involved in the trial.
The first compound to be studied will be psilocybin, a psychedelic prodrug compound that can be produced by more than 200 species of mushrooms. The initial protocol will involve three doses in a study spread over 12 weeks.
It is believed this is the first tial of its kind.
Dr. Rakesh Jetly, OMM, CD, MD, FRCPC, currently serves as the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario. He is also an associate professor of psychiatry at Dalhousie University (Halifax), and the University of Ottawa, as well as a scientific advisor for NeuroPharm.
When prompted about the trial, Dr. Jetly explained that, while PTSD occurs throughout society, it impacts military and veteran populations at a higher rate.
Currently, PTSD is most commonly treated using a combination of exposure therapies and medication.
“Unfortunately, in a significant proportion of veterans suffering from PTSD these treatments are either ineffective or only partially effective. Hence, efforts continue throughout the world to find safe and effective treatments for PTSD,” he said.
But, where do psychedelics come in?
As Dr. Jetly explained, psychedelic medications have been used for years, most frequently to address issues related with the mind.
“In fact, there are many well-designed and executed studies that have been published in peer-reviewed journals. Prestigious universities and academics are heavily involved in the studies,” he voiced, bringing up examples of studies evaluating 3,4-methylenedioxy-methamphetamine (MDMA) for the treatment of PTSD, and psilocybin, for the treatment of depression.
“These preliminary trials have been so impressive that they have led to the FDA to designate MDMA and psilocybin ‘breakthrough therapies’ for PTSD and treatment-resistant depression, respectively,” he added.
There are, however, no published, peer-reviewed studies looking at psilocybin for the treatment of PTSD in veteran populations so far.
“There is evidence that veterans are particularly hard to treat with conventional evidence-based therapies, which increases the need for novel therapies there are safe and effective,” Dr. Jetly said.
This is what NeuroPharm and LUMC will be doing.
It’s important for readers to understand that these trials are not “drug trials.”
NeuroPharm and LUMC will be administering psilocybin in a safe and controlled environment, facilitating healing through psychotherapy.
“As such, these are ‘medication-assisted psychotherapy’ trials. We are interested in the safety and efficacy of our approach,” the Dr. said.
“Many people are ‘defended’ psychologically. This blocks them from accessing their deepest feelings, such as guilt, shame or fear, and it is felt that the hallucinogens help lower this resistance or defence to allow the individual and therapist access to these core feelings.”
Ultimately, the researchers hope the results of this trial will help veterans suffering from PTSD and struggling with the reincorporation into civilian life.
“My hope is that through a relatively short course of medication assisted psychotherapy we can help lift depression and lessen the acuity of these haunting memories. We can hopefully integrate these traumatic memories and give them a place to rest ‘in the past,’” Dr. Jetly commented, adding the trial will also explore medication-assisted psychotherapy for the treatment of Moral Injury, a type of feeling often experienced by veterans suffering from PTSD.
Responsible clinical research takes time, and NeuroPharm and LUMC intend to do things the right way.
The trials will start in LUMC under the supervision of Prof. Eric Vermetten, and then spread throughout Europe, North America and the Caribbean. Some of these trials are already being prepared.
But, before the first iteration kicks off, a clinical protocol needs to be finalized, submitted to a university Research Ethics Board (REB), and subsequently approved by this REB.
The team anticipates the trial will commence some time this year.
The processing North America also involves approvals from regulatory bodies such as Health Canada and the FDA as well. The company says it’s already working on these.
“I feel that there were likely also some refinement of the compounds perhaps developing a psilocybin with a shorter duration of action (or half-life) or indeed we may identify clinical benefit with a lesser psychedelic experience. In time it is my belief that safe and effective compounds and approaches will make it into mainstream medicine and reduce the overall burden caused by mental illness,” Dr. Jetly concluded.
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