FDA approves clinical trials of a new psychotherapy model to treat COVID related anxiety and depression in frontline healthcare workers.
The U.S. Food and Drugs Administration (FDA) has approved biotech company Cybin’s Phase 2 clinical trials evaluating the efficacy of psychedelic-assisted therapy in treating frontline clinicians experiencing COVID-related distress, Benzinga reports.
As part of the trials, therapists participating in the clinical study will be trained using the EMBARK program. This is a psychotherapy model that strives to deliver supportive healing alongside psychedelic therapeutics.
The program is designed as a transdiagnostic psychotherapy model that can be adapted and used to treat a wide variety of conditions including depression, alcohol use disorder and anxiety.
EMBARK’s six clinical domains are:
- Body Aware
- Keeping Momentum
These key areas represent the spectrum of ways in which therapeutic benefits may arise in psychedelic treatment. Therapists must receive equally broad training to prepare them with the tools required to offer strong patient support.
Dr. Alex Belser, EMBARK’s co-author and Chief Clinical Officer at Cybin explains that EMBARK was developed to provide an architecture to support the huge scope of psychedelic experiences within a comprehensive therapeutic framework.
This new program addresses less studied aspects in current psychedelic therapeutic models. Areas such as a patient’s spiritual experiences, somatic experiences and human relationships will be brought into focus to reflect the central role these can play in the healing process.
Psychedelic therapies are increasingly being used to treat PTSD experienced by people in occupations that navigate the trauma of others on a daily basis, such as firefighters, police, healthcare workers and military personnel.
FDA: Psilocybin is a ‘Breakthrough Therapy’
Dr. Anthony Back, palliative care specialist and the trial’s primary investigator, received an investigational new drug (IND) approval letter from the FDA, granting the company authority to proceed with the study.
The FDA states that IND’s may be employed for “experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.”
The FDA’s designation of psilocybin as a ‘breakthrough therapy’ in 2018 was designed to accelerate the development and review of new treatments for serious or life-threatening conditions. Cybin’s psilocybin trials to address pandemic-related distress in frontline workers are a prime example of this.
Dr. Besler emphasizes the huge impact that the Covid-19 pandemic has had on frontline workers who have worked hard in extremely difficult conditions. Many nurses, doctors and healthcare professionals are now experiencing symptoms of depression and burnout as a result of these circumstances.
Set to be conducted at the University of Washington, the Phase 2 clinical trials will enlist 30 frontline clinicians. This participant set will include physicians, nurse practitioners, physician assistants and nurses suffering from clinically significant symptoms of depression and anxiety following work exposure during the pandemic.
Cybin hopes this trial will generate clinical evidence which validates the efficacy of EMBARK and allows for the application of the findings to future psychedelic treatments.
To explore additional psychedelic content, click here.