Our Expanded Access Program study site at Sage Integrative Health in Berkeley, California, began screening participants for MDMA-assisted therapy for PTSD in early March.
Our multi-site expanded access study site for MDMA-assisted therapy for patients with treatment-resistant PTSD at the Pearl Psychedelic Institute in Waynesville, North Carolina, was activated for phone screening in December 2021 and is continuing to screen participants. Expanded Access is a program that allows patients to receive an investigational treatment not yet approved by the United States Food and Drug Administration (FDA) outside of a clinical trial. The program is for patients with serious or life-threatening conditions who do not have promising treatment options and are unable to participate in ongoing clinical trials. Only sites within the U.S and U.S territories are eligible to participate in the FDA Expanded Access Program.
