Common side effects of MDMA-assisted psychotherapy

MDMA-assisted psychotherapy shows promise for treating psychiatric conditions, with clinical trials over the past decade demonstrating safety and efficacy for posttraumatic stress disorder (PTSD). In 2024, the U.S. Food and Drug Administration granted priority review for a new drug application involving MDMA-assisted psychotherapy for PTSD, following a Breakthrough Therapy designation in 2017. Australia became the first country to authorize MDMA prescriptions for PTSD. Beyond PTSD, evidence from clinical trials indicates that MDMA-assisted psychotherapy is safe, tolerable, and effective for alcohol use disorder, autism, and end-of-life anxiety.

Study at a glance

Abstract

MDMA-assisted psychotherapy has emerged as a potential treatment for psychiatric illnesses, with findings from clinical trials in the last decade demonstrating safety and efficacy in the treatment of posttraumatic stress disorder (PTSD), among other psychiatric indications. Earlier this year (2024), the Food and Drug Administration in the United States granted priority review for a new drug application involving MDMA-assisted psychotherapy for PTSD, which followed their Breakthrough Therapy designation for MDMA-assisted psychotherapy in 2017 [ 1 ]. In addition, the Australian Therapeutic Goods Administration has authorized MDMA prescriptions for PTSD, making Australia the first country to recognize medical uses for MDMA [ 2 ]. Beyond PTSD, evidence from clinical trials indicates that MDMA-assisted psychotherapy is safe, tolerable, and effective in patients with alcohol use disorder, autism, and end-of-life anxiety [ 3 ].