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An Open Label Study to Treat Post-Traumatic Stress in COVID-19 Healthcare Workers Using MDMA-Assisted Therapy

The COVID-19 Pandemic

Healthcare workers were traumatized by the COVID-19 pandemic in New York City. 

In the Spring of 2020, we were all witness to the heroic efforts of our medical workers as they showed up to work, day after day, at grave risk to themselves and their families. As an unprecedented flood of patients suffering from a deadly and previously unknown illness crashed through the doors of emergency departments and intensive care units across the city, these workers discovered that the hospital infrastructures they had relied on for their entire careers were insufficient to mount an adequate response. For many, personal protective equipment shortages made the prospect of going to work feel much more dangerous than before. Ventilator shortages forced some to decide, on a daily basis for months on end, which suffocating patient would receive the life-saving benefit of mechanical breath, and which would have to be denied. Colleagues fell sick; some died; many returned to work before they were fully recovered - often because it was intolerable for them to imagine their co-workers facing the crisis without them. 

For doctors and nurses, the patient care they provided no longer included 1:1 attention and human touch. With no family members present to provide company and support to those who were sick and dying, it fell on healthcare workers to bear witness to excessive amounts of suffering and death, often helplessly and at a distance. Their experiences are heart wrenching:

"I watched my patient suffocate through the window. We accused ourselves, while admitting it was true. … In the minutes it took to put our PPE on, we had watched our patients die.  In a quiet side reaction, we felt the good things leave our body, and grief come to stay. … We leaned forward and bowed our heads in order to redirect the flow of tears. We couldn’t risk touching our faces and we needed them to fall onto our scrubs. We couldn’t ruin our masks."

The horrors of the pandemic, and its aftermath, have highlighted the critical need to focus on the mental health of medical workers involved in the response to this emergency. Studies over the past decade have consistently found that this population of workers were already experiencing some of the highest rates of burn-out, PTSD, and suicide of any profession anywhere. The United Nations noted the impact of the pandemic on healthcare workers in its May 2020 Policy Brief, calling attention to the “historic underinvestment in mental health” that needs to be “redressed without delay to reduce immense suffering …and mitigate long-term social and economic costs to society.”

MDMA-assisted therapy for COVID-19 Frontline Healthcare Workers

Nautilus Sanctuary is one of a handful of clinics in the world set up and trained to do this drug-assisted therapy. We are boots on the ground ready to deliver this treatment to a population in need. Not only is this a highly effective treatment to help people heal after the fall-out from recent traumatic events, the advent and rise of MDMA-assisted therapy is a response to a growing awareness of and need among mental health professionals for more powerful treatments to help their clients who are suffering from an array of trauma-borne difficulties, often beginning in childhood. Our study serves several purposes:

• To provide relief and healing for healthcare workers who are suffering from symptoms of depression, anxiety, insomnia, substance abuse, and burn-out because of their experiences working during the COVID-19 pandemic. 

• To provide training opportunities for new therapists. An important and final requirement for newly trained therapists who wish to receive certification in MDMA-assisted therapy is to team up with an experienced clinician and have a hands-on experience in providing the treatment under expert guidance. MAPS has identified the training of new therapists as the single most important barrier that must be overcome in order to provide this treatment at a large-scale post-FDA approval, which is anticipated to be granted in late 2024. We are happy to support MAPS in their mission to train the next generation of therapists so that this treatment can be widely available in the years to come.

• To gather data on the effectiveness and safety of this treatment to help people return to baseline functioning after a traumatic experience. In particular, we are interested in understanding the factors that potentially facilitate or complicate the course of treatment; i.e., level of social support, prior history of trauma in the participants; style and personality of the therapist.

• To expand the clinical applications for MDMA-assisted therapy. Our study seeks to treat more iterations of Stress- and Trauma- Related Disorders (recent onset post-traumatic stress versus chronic, treatment-resistant, moderate to severe PTSD now being studied in the MAPS clinical trials). 

Project Budget

As an Investigator-Initiated Trial approved by MAPS, we have MAPS’ permission to use their pharmaceutical grade MDMA under their FDA investigational drug permit, but the responsibility for funding falls completely to Nautilus Sanctuary.

The cost to conduct the project over two years is approximately $1,000,000. This will allow us to bring this treatment free of charge to 20 COVID-affected frontline NYC healthcare workers and allow 20 new MDMA therapists-in-training to complete their certification, so they can go on to establish their own practices around the city and the country and deliver this groundbreaking new treatment to populations in dire need of it.

A more detailed budget is available upon request. 

Contact:

Willa Hall, Ph.D. 

willa@nautilussanctuary.org

917-509-1497

or

Casey Paleos, MD

casey@nautilussanctuary.org

631-637-1953