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In June 2023, FDA issued its first psychedelics draft guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, to provide general considerations to sponsors developing psychedelic drugs for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.

Day 1 Agenda

10:00am
 

Welcome

Susan C. Winckler, RPh, Esq., Reagan-Udall Foundation for the FDA

10:05am

 

Opening Remarks

Patrizia Cavazzoni, MD, U.S. Food and Drug Administration

10:15am

 

Session 1: Overview of FDA's Psychedelics Clinical Investigation Guidance

Tiffany Farchione, MD, U.S. Food and Drug Administration

10:40am

 

 

 


 

Session 2: Psychedelics Study Design, Control Conditions, and Blinding

Speakers:

  • Suresh Muthukumaraswamy, PhD, University of Aukland
  • Franz Vollenweider, MD, University of Zürich

Respondents:

  • Matt Butler, MD, King's College London
  • Michael Davis, MD, PhD, Usona Institute
  • Bernard Fischer, MD, U.S. Food and Drug Administration
11:40am

BREAK

11:50pm

 

 

 

 

 

 

Session 3: Dosing

Speakers:

  • Robert Barrow, MSc, MindMed
  • Guy Goodwin, DPhil, Compass Pathways 
  • Berra Yazar-Klosinski, PhD, Lykos Therapeutics

Respondents:

  • Peter Hendricks, PhD, University of Alabama Birmingham
  • Jennifer Mitchell, PhD, University of California, San Francisco
  • Martine Solages, MD, U.S. Food and Drug Administration 

1:00pm

 

 

 

 

Session 4: Durability of Treatment Response

Speakers:

  • Michael P. Bogenschutz, MD, NYU Langone Center for Psychedelic Medicine
  • Carla Canuso, MD, Johnson & Johnson Innovative Medicine

Respondents:

  • Valentina Mantua, MD, PhD, U.S. Food and Drug Administration
  • Charles L. Raison, MD, University of Wisconsin-Madison
2:00pm Adjourn

Day 2 Agenda

10:00am

 

Welcome

Susan C. Winckler, RPh, Esq., Reagan-Udall Foundation for the FDA

10:10am

 

 

 

 

Session 5: Set and Setting

Speakers:

  • Ido Hartogsohn, PhD, Bar-Ilan University
  • David Yaden, PhD, Johns Hopkins University

Respondents:

  • Brian Anderson, MD, University of California, San Francisco
  • Javier Muniz, MD, U.S. Food and Drug Administration

11:20am

 

Session 6: Overview of FDA Regulatory Authority

Tiffany Farchione, MD, U.S. Food and Drug Administration

11:40am

 

 

 

 

Session 7: Considerations for Potential Psychedelic Use in the Real World

Speakers:

  • Richard C. Dart, MD, PhD, Denver Health and Hospital Authority
  • Mason Marks, MD, JD, Harvard Law School
  • Mark H. Rapaport, MD, University of Utah School of Medicine
  • Lisa Robin, MLA, Federation of State Medical Boards
  • Marta Sokolowska, PhD, U.S. Food and Drug Administration
  • Ilse Wiechers, MD, MPP, MHS, U.S. Department of Veteran Affairs

12:55pm

 

Closing Remarks

Susan C. Winckler, RPh, Esq, Reagan-Udall Foundation for the FDA

1:00pm

Adjourn

 

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.