Psychedelics have a storied history in health care. However, societal and regulatory shifts in the 1960s and 1970s led to their classification as Schedule I substances. In recent decades, the narrative has shifted, with a resurgence of interest in the therapeutic potential of psychedelics for conditions like depression, post-traumatic stress disorder (PTSD) and addiction.
Recently, there has been a surge in clinical trials on psychedelics, accumulating data rapidly. Notably, the Multidisciplinary Association for Psychedelic Studies (MAPS) submitted an application to the Food and Drug Administration (FDA) for psychedelic-assisted psychotherapy using 3,4 methylenedioxymethamphetamine (MDMA) for PTSD, marking a significant step toward potential clinical availability. This submission reflects the evolving landscape of psychedelics in health care, with ongoing research exploring their therapeutic potential beyond end-of-life care to address mood disorders and PTSD. The field is poised for advancements as regulatory agencies consider approving psychedelic-assisted therapies for broader clinical use.
Ohio State is engaged in a wide array of research into psychedelic drugs and their uses to treat mental illness at both The Center for Psychedelic Drug Research and Education (CPDRE) and the Psychiatry and Behavioral Health Department at The Ohio State University Wexner Medical Center.
The primary focus of an ongoing phase III clinical trial is a psilocybin compound developed by the company COMPASS as a potential option for treatment-resistant depression. Subhdeep Virk, MD, MBBS, director of the Treatment-Resistant Depression Program at Ohio State and the principal investigator of this trial, hopes that this research can help develop a novel class of rapidly acting antidepressants for patients who have not responded to multiple trials of conventional antidepressants.
“What excites me the most in the area of rapidly acting antidepressants is studying their mechanism of action, robust response and, in combination with psychotherapy, getting better outcomes,” Dr. Virk says. “Ketamine was a trailblazer in the field, and I think psilocybin has the potential to follow closely. We are looking at treatments that are quick acting and have sustained effects, and that gives hope to both patients and their providers.”
K. Luan Phan, MD, chair of Ohio State’s Department of Psychiatry and Behavioral Health, is a therapist for the trial. He emphasizes the importance of understanding the psychological and biological mechanisms of change induced by psychedelics supported by psychotherapy. Dr. Phan explains, “Understanding the mechanism of change is fundamental to the eventual success of this strategy. It matters, of course, in a scientific way, to better understand how psychedelics exert their therapeutic effects, but it also matters in a pragmatic way because it is unknown how the medication interacts with the psychotherapy, which requires additional clinical resources.” Plans are underway to conduct research to delineate the role of each component and how the treatment may restore brain health in patients and for whom.
Understanding the resources necessary to deliver these treatments in a clinical setting is critical because resource drain is a significant challenge to overcome should psychedelic-assisted psychotherapy move forward to mainstream clinical practice. Of note, a session during which a psychedelic is administered lasts 6-8 hours and involves a prescribing physician and two therapists. Not only is this type of therapy contextually different for the provider, but the current infrastructure around licensure could make certification a lengthy and resource-intensive process for providers. And it could put access out of reach for many populations that could benefit from the treatment.
Depression is a pervasive and debilitating condition affecting millions worldwide. Traditional treatments, while effective for some, leave a significant portion of patients with unresolved symptoms or no improvement at all. This gap in treatment efficacy underscores the urgent need for innovative approaches. The CPDRE at The Ohio State University is at the forefront of such innovation, exploring the therapeutic potential of psychedelics for mental health disorders.
Housed in the College of Social Work, the CPDRE is a hub for clinical trials, public health research, and education for both providers and the public about psychedelic drugs. As the center’s director, Alan Davis, PhD, explains, “We believe that not only will clinicians need to understand these treatments, but families will need to understand what these experiences are, as well.”
Dr. Davis’ work at the CPDRE is critical to bridging the resource gap and proactively addressing some of these challenges through education for both the provider and the public. This interdisciplinary approach and collaboration between the center and the department of psychiatry combines expertise — in areas such as PTSD, depression and addiction — and a mechanistic outlook that is essential for advancing the field and expediting the translation of discoveries into clinical applications.
“The clinical trial serves as the point of foundation for us to advance the science, but it is just the foundation. It allows the other work that needs to happen,” Dr. Davis says. “We can’t assume that these treatments are going to work the same in every community, and we have to have a better knowledge base of doing studies in all of these populations so that we can best understand the nuances of how these treatments unfold for people.”
An essential part of this research that often gets overlooked is creating a shared context of understanding these therapies and how they are experienced. “When psychedelics were used in indigenous settings, they were built into a culture that had similar values and a shared understanding of what these experiences were. We don’t have any of that,” Dr. Davis explains. “One way we need to think about how this treatment should be embedded in our culture is through connection to families, communities and systems, just like they did when these medicines were used in indigenous cultures.”
The potential impact of psychedelic medications on mental health treatment is vast. Ohio State’s research and training programs could lead to revolutionary changes in treating depression, anxiety, addiction and comorbid conditions. Future directions include more mechanistic research, clinical trials and the possibility of FDA approval for certain psychedelic therapies.
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Psilocybin-assisted psychotherapy for treatment of major depression | Ohio State Medical Center – Wexner Medical Center – The Ohio State University
