Definitions/Description

• MDMA is an amphetamine with unique serotonergic effects[1], increasing release of serotonin, dopamine, and norepinephrine via their respective transporters, with downstream changes in oxytocin. In addition to stimulant-like increases in energy and mood, MDMA produces empathogenic effects, including heightened trust, openness, and a sense of psychological safety. The rationale for MDMA-assisted psychotherapy is that these unique effects may facilitate engagement with psychotherapy.
• MDMA-assisted psychotherapy (MDMA-AP) combines MDMA with psychotherapy and has been most extensively studied for posttraumatic stress disorder (PTSD) culminating in two Phase 3 trials sponsored by Lykos Therapeutics, in which MDMA-AP met safety and efficacy endpoints. However, the FDA did not approve the new drug application, and additional trials will likely be required.