The US Food and Drug Administration (FDA) has given authorisation for a Phase II clinical trial to evaluate psychedelic-assisted psychotherapy for frontline clinicians who are experiencing COVID-related distress.
Biopharmaceutical company, Cynbin Inc., will carry out the Phase II investigator-initiated randomised, placebo-controlled clinical trial evaluating psychedelic-assisted therapy with psilocybin for COVID-19 frontline workers including doctors, nurses and healthcare professionals.
The trial will be conducted at the University of Washington and will aim to treat COVID-19-related distress symptoms including depression, anxiety, burnout and post-traumatic stress disorder (PTSD). The trial will be hosted in Seattle, a city significantly impacted by the COVID-19 pandemic and will be funded by multiple organizations
Primary Investigator, Dr Anthony Back, received an investigational new drug (IND) approval letter from the FDA.
Dr Anthony Back, commented: “This study offers an important opportunity to assess psychedelics-assisted therapy as a new modality for clinicians who have suffered as a result of their frontline work in the pandemic.”
Cybin’s chief clinical officer, Alex Belser, PhD and Bill Brennan, PhD (candidate) have developed EMBARK, a six-domain model of psychedelic-assisted psychotherapy which was designed as a transdiagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations.
In collaboration with Dr Back and Ladybird Morgan, RN, MSW, an adapted version of EMBARK has been co-authored to treat COVID-related burnout and symptoms of depression. This version includes material that specifically addresses cultural inclusion anticipating a diverse population of clinicians.
Dr Alex Belser, Cybin’s chief clinical officer, commented: “Throughout the COVID-19 pandemic, nurses, doctors, and healthcare professionals on the frontlines have worked hard to provide care under extremely difficult circumstances.
“Understandably, under this stress, many frontline healthcare workers have experienced symptoms of depression and burnout. We believe psychedelic medicine, when given with a supportive psychotherapy program like the EMBARK approach, may provide a promising treatment approach to bolster mental health.”
“This clinical trial provides an opportunity to better understand the effectiveness of combining psilocybin and EMBARK. Learnings from this combination Phase II trial will inform the use of EMBARK in Cybin’s upcoming human studies using CYB003, a proprietary deuterated psilocybin analog that has the potential to reduce clinic times and dosing levels in half as well as potentially reduce side effects and adverse events,” added Doug Drysdale, CEO of Cybin.
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