Researchers receive funding to launch USC’s first clinical study of psilocybin for mental health
The goal of USC’s first-ever study of psychedelic therapy is to conduct a clinical trial to determine whether mindfulness meditation training can augment the potential benefits of psilocybin therapy for mental well-being and cognitive function
Researchers at the Keck School of Medicine of USC, the Brain and Creativity Institute at the USC Dornsife College of Letters, Arts and Sciences, and the USC Norris Comprehensive Cancer Center have launched the University of Southern California’s first study of psychedelic therapy. This clinical trial focuses on psilocybin, a psychedelic chemical found in certain types of mushrooms throughout the world, which has shown promise for treating substance abuse and other mental health disorders. Recruiting healthy community-based volunteers, the research team hopes to determine if structured mindfulness meditation training can augment psilocybin-assisted therapy, using a comprehensive battery of physiological, biological, cognitive, and psychosocial measures.
The research is being funded by an award from the Advanced Research Projects Agency for Health (ARPA-H) through its Evidence-Based Validation & Innovation for Rapid-Acting Treatments (EVIDENT) initiative. The initiative is designed to help spur the development of more effective treatments and more personalized care for people with mental or behavioral health disorders.
The study is co-led at USC by Rael Cahn, MD, PhD, director of the USC Center for Mindfulness Science and clinical associate professor of psychiatry and the behavioral sciences and Caryn Lerman, PhD, director of the USC Norris Comprehensive Cancer Center and Distinguished Professor of Psychiatry and Behavioral Sciences, and Psychology, both in the Department of Psychiatry and the Behavioral Sciences at the Keck School of Medicine. The study will be conducted at Cahn’s lab at the USC Brain and Creativity Institute (BCI) and in collaboration with other BCI researchers, including Assal Habibi, PhD, director of the USC Center for Music, Brain and Society, Jonas Kaplan, PhD, co-director of the USC Dornsife Cognitive Neuroimaging Institute and John Monterosso, PhD, professor of psychology at USC Dornsife.
Psilocybin and mental health
Psilocybin profoundly alters perception, mood and cognition, in some cases causing people to experience distorted sights and sounds or lose their sense of time and space. Research suggests that, with sufficient therapeutic support, psilocybin therapy can lead to emotionally meaningful spiritual experiences.
Although it is currently listed as a Schedule 1 drug under the Controlled Substances Act, the FDA has recently granted psilocybin a “breakthrough therapy” designation for its potential in treating major depressive disorder and treatment-resistant depression. Preliminary evidence suggests it may improve the conditions substantially compared to other available treatments. Other research has shown promising results for its use in treating addiction.
“Psilocybin-assisted therapy has the potential to revolutionize how we approach mental health research,” said Caryn Lerman. “There is growing evidence that these treatments may have important applications not only for addiction, but also for improving quality of life and emotional well-being for people facing serious illness and end-of-life challenges. This study allows us to rigorously explore that potential while contributing valuable data to a national research effort.”
The trial will evaluate the potential benefits of offering psilocybin within an eight-week mindfulness meditation training program. Participants will be randomized to receive psilocybin alone under supervision or psilocybin with mindfulness training, a systematic method to help focus awareness and attention through a series of meditative practices. Mindfulness training has been shown to produce significant mental and physical health benefits, leading the researchers to hypothesize that combining it with psilocybin could lead to improved outcomes over psilocybin assisted therapy on its own.
Evaluation with comprehensive data
Researchers will enroll approximately 72 middle-aged adults from the Los Angeles community who have no current psychiatric or medical pathology and no previous experience with psychedelic use or meditation practice. Participants will receive psilocybin-assisted therapy sessions as part of a structured therapeutic protocol offered at the USC Brain and Creativity Institute. The trial will be open label, so participants and researchers will know which treatment they’ve been assigned.
Participants will also complete a comprehensive series of assessments, including EEG, brain MRI/fMRI scans, salivary, blood, and stool samples as well as psychological and cognitive measures before and after treatment. They will also complete follow-up surveys at approximately 3 months, 6 months, and one year after the treatments. Researchers will evaluate the data to determine potential effects on psychological well-being, spirituality, cognitive functioning, brain activity related to self and narrative processing, and biological markers related to inflammation and brain health.
“Mindfulness meditation practice provides people with the tools to deconstruct unhelpful narratives, a process that may be amplified by psilocybin-assisted therapy,” said Rael Cahn. “By combining mindfulness training with psilocybin-assisted therapy, we hope to better understand how these practices may enhance both the potential immediate and longer-term effects of psychedelic medicine.”
About the study
The study is supported by ARPA-H’s EVIDENT program, which aims to accelerate behavioral health research through detailed, real-time clinical data collection. Using digital tools, brain measures, and biological sampling, EVIDENT-supported studies contribute de-identified data to a secure national repository, helping researchers identify patterns associated with rapid changes in mental health. ARPA-H is an agency within the U.S. Department of Health and Human Services that supports bold, high-impact research designed to transform health outcomes.
This research was funded, in part, by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government
For more information about ARPA-H, visit ARPA-H.gov.
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