On January 30, 2026, the Multidisciplinary Association for Psychedelic Studies (MAPS) submitted MJP2 Protocol Amendment 4, Version 1 (A4V1) to the U.S. Food and Drug Administration (FDA) for review.
This amendment was developed to complete administrative and operational refinements in advance of study initiation. Amendment 4, Version 1 updates the previously cleared smoking-only protocol (A3V1) and was developed to remove duplicative procedures, update screening and secondary outcome measures to reduce participant burden, and incorporate administrative updates for clarity and consistency.
MAPS will continue to work with FDA to support study initiation and regulatory compliance. Read the submission cover letter and MJP2 Protocol Amendment 4, Version 1 (A4V1) here.