FDA Removes Partial Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On May 11, 2021, nearly two years following the initial protocol submission of MT2 to the U.S. Food and Drug Administration (FDA), the FDA Division of Psychiatry removed the partial clinical hold on Study MT2.

The deciding official issued a letter, agreeing on all counts with the arguments submitted by MAPS in response to the partial clinical hold issues. The letter specifically notes that Study MT2 does not carry a more unfavorable risk:benefit ratio than prior studies and that clinical investigators requirements should not be held to a different standard than prior approved studies (Study MT1). With this decision, clinical investigators should not be required to have a doctoral level degree, and that physicians should not be required on site.