Investigator-Initiated Trials: April 2022 Update

We are excited to share recent progress with our investigator-initiated trial (IIT) program! The MAPS Public Benefit Corporation (MAPS PBC) IIT program is designed to create an ever-growing network of qualified clinicians whose passion and innovative questioning help to inspire new possibilities within the path to expanding patient access and the conditions that MDMA-assisted therapy may be possible in treating.

Dr. Jason Luoma and a team of researchers at Portland Psychotherapy in Portland, Oregon, are conducting a study to assess the safety and effectiveness of MDMA-assisted therapy in treating individuals with moderate-to-severe social anxiety disorder (SAD). The team at Portland Psychotherapy plans to treat up to 20 participants.

Dr. Stephen Bright and a team of researchers at Edith Cowan University in Joondalup, Western Australia, are conducting a study to assess the safety and effect of manualised MDMA-assisted therapy for the treatment of severe PTSD among four Australians. This study is also being conducted for the training of the therapists by providing supervision as the therapists work with their initial patients. The team has received the study drug and will begin recruiting participants over the coming months.

Dr. Shannon Remick, Dr. Anne Wagner, and Dr. Leanne Wiliams continue to conduct their investigator-initiated trials at their respective institutions. At the Veterans Affairs (VA) Loma Linda Healthcare System in Loma Linda, California, Dr. Shannon Remick and a team of researchers are conducting an open-label study to assess the feasibility of MDMA-assisted therapy for combat-related treatment-resistant PTSD in U.S. military veterans. The VA Loma Linda team plans to treat up to 10 participants.

Dr. Anne Wagner and a team of researchers at Remedy Institute in Toronto, Ontario, are conducting an open-label treatment development study of MDMA-assisted cognitive processing therapy (CPT) for individuals with PTSD. The team at Remedy Institute plans to treat up to 10 participants.

Dr. Leanne Williams and a team of researchers at Stanford University in Stanford, California, are conducting an observational study to assess the impact of MDMA on the regulating circuits of the brain in healthy individuals using fMRI. This is the first mechanistic study with MDMA to be funded by NIDA.  The study will enroll up to 40 participants.