Understanding, Measuring, and Addressing Adverse Effects of Psychedelics for Clinical Research and Harm Reduction

About This Grant

PROJECT SUMMARY Psychedelics have shown strong potential to improve multiple difficult-to-treat mental health conditions. Defining and measuring post-acute psychedelic-related adverse effects (AEs) is a necessary step toward enhancing the safety of psychedelic interventions, developing strategies to reduce likelihood of persisting AEs, and for developing treatments for persisting AEs when they occur. Persisting AEs of psychedelics, recognized in scientific literature, are poorly captured by existing assessments. This K23 will validate a measure of post- psychedelic AEs, characterize AE profiles liked with persisting impairment, and develop consensus-based strategies for prevention and treatment of post-acute psychedelic AEs. Candidate: Dr. Palitsky is a clinical psychologist with a strong background investigating determinants of differential response to interventions, acquired through doctoral training and a postdoctoral fellowship. An Assistant Professor at Emory University School of Medicine, his career aim is to lead a R01-funded program of research that enhances the safety of multicomponent psychiatric interventions including, but not limited to, psychedelics. Training: Dr. Palitsky’s career goals require additional training in psychedelic-assisted therapy development, clinical trials, biostatistics including structural equation modeling and psychometrics, and translational impact and scientific leadership to inform standards and policy. Accordingly, this K23 leverages multidisciplinary training in Emory’s departments of Psychiatry, Health Sciences, and Ethics, alongside individualized curricula using extramural resources tailored to his needs. Training includes formal coursework, individualized training with mentors, and structured career development support. Mentoring: An exceptional team of investigators committed to mentoring Dr. Palitsky include: Primary mentor Dr. Barbara Rothbaum, PhD, who has expertise in psychotherapy development and psychedelic-assisted therapies, and co-mentors with expertise in clinical trials and psychopharmacology (Dr. Boadie Dunlop, MD), biostatistics (Dr. Job Chen, PhD), and translational impact and scientific leadership (Dr. Charles Raison, MD). A significant contributor, Dr. Todd Korthuis, MD, will give expert oversight on Delphi methodology and recruitment for population health research. Research: Leveraging existing studies and established partnerships with psychedelics safety research stakeholders, this project will validate a preliminary measure post-acute psychedelic AEs initially developed by the PI (N = 940); characterize persisting AE profiles using a longitudinal study (N = 400, 6 waves in 1 year); and produce consensus on primary and secondary prevention strategies using a Delphi study (N = 25). Products include 7 planned manuscripts, a living protocol for psychedelic AE measurement, and an R34 and R01 submitted by the applicant. Environment: The candidate receives strong institutional support from the Department of Psychiatry and Behavioral Sciences. The training environment includes multiple Emory collaborative health institutes and Emory’s Mood and Anxiety Disorders Clinic, the site for the applicant’s planned R34 and R01.