New center established at NYU Langone Health to expand psychedelic research and training

Philanthropic support from several donors totaling over $10 million will allow NYU Langone Health to advance its already world-renowned reputation in the field of psychedelic medicine through the establishment of a one-of-a-kind center dedicated to expanding research and professional medical training in this resurging field.

When fully developed, the NYU Langone Center for Psychedelic Medicine, under the auspices of NYU Langone's Department of Psychiatry, will support health-focused research across the translational spectrum, from basic science to Phase III clinical trials. Principally, it will have three transdisciplinary areas of focus: psychiatry, medicine and preclinical research.

In addition, a robust training program, the Psychedelic Medicine Research Training Program — which differentiates this center from others – will support the development of early career faculty members and post-doctoral fellows to become independent investigators in the field of psychedelic medicine.

In addition, the Psychedelic Medicine Research Training Program aims to work with members of the psychedelic medicine industry to develop treatment models and training programs to help to scale psychedelic medicines into mainstream adoption by psychiatrists and therapists in America.

"These initiatives will provide an environment in which scientists, clinicians, trainees and other staff contribute in meaningful ways to ensure that the momentum created by the modern psychedelic renaissance is sustained and continues to yield medical breakthroughs backed by sound science," says Michael P. Bogenschutz, MD, Professor of Psychiatry at NYU Grossman School of Medicine, and an acknowledged leader in the field of psychedelic medicine who will serve as the Center's director.

Another unique aspect of the NYU Langone Center for Psychedelic Medicine is its commitment to move beyond the confines of psychiatry, expanding its focus into clinical applications across other health disciplines.

"Our broad focus on discovery for medical applications of psychedelics places NYU Langone at the vanguard of research on many difficult-to-treat psychiatric and medical disorders," says Stephen Ross, MD, associate professor of Psychiatry at NYU Grossman School of Medicine, and a fellow leader in the field who will serve as the Center's associate director. "Moreover, we plan to utilize this health-focused structure to provide important training opportunities to sustain high-quality psychedelic research."

Philanthropy key to expanding psychedelic research and training

Principal funding for the Center comes from a consortium of individuals and organizations, all sharing a singular mission to advance the already groundbreaking work achieved in psychedelic medicine since its resurgence as a sub-specialty over the past 25 years.

Leading the way is funding support of $5 million from MindMed, a neuro-pharmaceutical company pioneering new ways to treat mental health disorders through the advancement of both non-hallucinogenic and hallucinogenic compounds. Specifically, it will help to establish a psychedelic-based training program for clinical investigators skilled in the study of psychedelic-inspired treatments for serious mental health needs. This gift will provide salary support, training and pilot research funds for four positions (two junior faculty and two post-doctoral fellows) over the course of five years.

We are honored and excited to help establish this first-of-its-kind training program at NYU Langone, which we believe will yield benefits to the overall advancement of psychedelic-inspired medicines in solving some of the most prevalent issues in mental health for patients. Few clinicians and institutions like NYU Langone Health and NYU Grossman School of Medicine are capable of conducting clinical research with psychedelic-inspired medicines. The need to train the next generation of investigators, and ultimately the entire psychiatry community in America, is critical to MindMed's mission of alleviating mental health with the use of psychedelics in the American mental healthcare system."

JR Rahn, Co-Founder and Chief Executive Officer, MindMed

The remainder of support to establish the Center will come from a $1 million gift from business leader and philanthropist Carey Turnbull, as well as from several seven-figure gifts that he galvanized from his network. He is president of the Heffter Research Institute, one of the country's leading non-profit organizations dedicated to supporting studies on hallucinogens like psilocybin for treatment of mental health and other disorders. NYU Langone and the Heffter Institute, through Turnbull's support, enjoy a long and successful partnership in psychedelic research.

"It is my pleasure to join with others in supporting NYU Langone Health's extraordinary efforts in the field of psychedelic medicine," said Turnbull. "Our organization truly believes that there are significant advancements that will come out of further examination and clinical trial work in this field, and are excited to direct our support behind it."

Other major gifts to support the NYU Langone Center for Psychedelic Medicine include:

• $2 million from Alan Fournier, a private investor and founder of Pennant Investors, LLC, with a history of support for psychedelic research and clinical trial activity
• $1 million from Bill Linton, board member and president of the Usona Institute, a non-profit medical research organization dedicated to supporting and conducting pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines
• Other significant donors include the George Sarlo Foundation, Cody Swift of the Riverstyx Foundation and Dr. Bronner's Soaps

Building on a legacy of groundbreaking work

The NYU Langone Center for Psychedelic Medicine will serve as the hub for NYU Langone's continuing efforts in psychedelics – work that already has garnered international acclaim, and which has been a major force in the field's successful resurgence. Past and current research focuses principally on the treatment of advanced cancer-related psychiatric and existential distress, addiction, major depression and posttraumatic stress disorder (PTSD). Among the initiatives underway in psychedelic medicine at NYU Langone:

• Dr. Bogenschutz is nearing completion as lead investigator of a Phase II clinical trial, sponsored by the Heffter Research Institute, examining the use of psilocybin to treat alcohol use disorder (AUD), and is developing a Phase II/III trial, sponsored by B.More (a philanthropic foundation led by Turnbull) with input from the US Food & Drug Administration.
• Dr. Ross was the lead investigator on a landmark 2016, double-blind, placebo-controlled Phase II study suggesting a role for psilocybin-assisted psychotherapy to treat anxiety and depression in cancer patients. A follow-up, multisite Phase III study is in development and a funding proposal to support additional research in this area is under review with the National Cancer Institute.
• Recruitment is currently underway for a Phase II study to evaluate the efficacy of a single dose of psilocybin in the context of brief supportive "set and setting" therapy for individuals with major depressive disorder (MDD). If the results of this study provide evidence of safety and efficacy, a Phase III study will be conducted under the "breakthrough therapy" designation supported by the FDA.
• NYU Langone recently completed a Phase III study on the safety and efficacy of psychotherapy utilizing methylenedioxy-methamphetamine (MDMA) for the treatment of severe PTSD, and has begun recruitment for a second Phase III study.

Other studies are examining and/or plan to examine the use of psychedelics/hallucinogens for disorders including chronic pain management, end-of-life psychotherapy, opioid use disorder and smoking cessation, to name a few.

"Drs. Bogenschutz and Ross have assembled outstanding scientific and clinical teams to carry out completed, ongoing and proposed psychedelic-focused studies at NYU Langone Health," says Charles R. Marmar, MD, the Lucius Littauer Professor and Chair of the Department of Psychiatry. "The infrastructure, support and training opportunities under the auspices of this new Center will springboard our psychedelic researcher efforts to new heights. We are very excited about what the future holds."