Advancing Psychedelic Clinical Study Design
Virtual Public Meeting
Day 1: January 31, 2024 | 10am-2pm (eastern)
Day 2: February 1, 2024 | 10am-1pm (eastern)
On January 31 and February 1 we convened "Advancing Psychedelic Clinical Study Design," a two-part virtual public meeting that explored empiric approaches to address key issues in psychedelic drug development and research.
In June 2023, FDA issued its first psychedelics draft guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions. While the guidance highlights some considerations for designing clinical trials with psychedelics to optimize the interpretability of results, many questions remain about the most appropriate way to address these challenges.
During this public meeting, we discussed the experience of scientists working with psychedelics in FDA-authorized clinical studies and drug development, considerations for psychedelics in clinical trial designs, and perspectives and current research in psychedelic clinical trials. We also provided an overview of Psychedelic Drugs: Considerations for Clinical Investigations.
Watch Part One
- Watch Session 1: Overview of FDA's Psychedelics Clinical Investigation Guidance
- Watch Session 2: Psychedelics Study Design, Control Conditions, and Blinding
- Watch Session 3: Dosing
- Watch Session 4: Durability of Treatment Response
Watch Part Two
- Watch Session 5: Set and Setting
- Watch Session 6: Overview of FDA Regulated Authority
- Watch Session 7: Considerations for Potential Psychedelic Use in the Real World
Funding Disclosure: This activity is one part of a multi-part Foundation project related to substance use disorder. The multi-part project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an overall award of $1,720,109 of federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.