An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Therapy for Eating Disorders
MAPS will conduct an open-label, multi-site Phase 2 study for MDMA as an adjunct to therapy for anorexia nervosa restricting subtype (AN-R) and binge-eating disorder (BED). This study will explore the safety and feasibility of MDMA-assisted therapy and adjunctive caregiver involvement in the treatment of individuals with AN-R and BED. The addition of a supportive caregiver as a treatment ally with every participant reflects this most recent development in science and practice. Supportive caregivers enrolled in the study will receive non-drug therapy support. The study will enroll 12 participants who meet the Diagnostic Statistical Manual for Mental Disorders Edition 5 (DSM-5) criteria for AN-R, and 6 participants who meet DSM-5 criteria for BED, for a total of 36 participants (12 AN-R, 6 BED, and 18 caregivers).
The study will take place at three study sites. The study site in Vancouver, Canada, will include six BED participants, with Qualified Investigator Christian Schütz, M.D., Ph.D., M.P.H, overseeing the study. The study sites in Toronto, Canada, and Denver, Colorado, will each include six AN-R participants, with Michael Verbora, M.D., overseeing as Qualified Investigator in Toronto, and Co-Clinical Investigators Adele Lafrance, Ph.D., and Mike Rollin, M.D., overseeing the site in Denver.