Challenges in Psychedelic Drug Development

With the recent renaissance in psychedelic research, clinical trials and development of new psychedelic compounds is growing exponentially. Psychedelics induce non-ordinary states of consciousness, which creates unique challenges in the design and conduct of research studies, including challenges with using appropriate comparator groups, maintaining treatment blind, managing patient expectations, inclusion of appropriate amount of psychological support, etc. Other issues such as differentiating between desired psychedelic effects that are critical for therapeutic benefit, from those that are adverse, assessment of durability of response, and designing an appropriate clinical development plan that could support a new drug application contribute to the complexity of psychedelic drug development. This session will discuss some of these topics that are critical to good clinical development in this space.