MT2: A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Therapy When Administered to Healthy Volunteers

On September 27, 2019, the U.S. Food and Drug Administration (FDA) replied to MAPS’ complete response to the partial clinical hold placed on Study MT2 by issuing a Continued Partial Clinical Hold Letter, …

On August 29, 2019, MAPS submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the partial clinical hold issues in the MAPS-sponsored Study MT2. The response supplied …

On August 5, 2019, the U.S. Food and Drug Administration (FDA) placed Study MT2 on partial clinical hold, preventing the study from being initiated. FDA highlighted their reason for the hold and concerns …

On May 21, 2019, MAPS submitted a new study protocol to the U.S. Food and Drug Administration (FDA) for a Phase 1 open-label, multi-site research study of the safety and psychological effects of manualized …