MDMA-Assisted Therapy for Anorexia Nervosa: Preliminary Evidence of Safety, Tolerability, and Effectiveness

Abstract

The purpose of this retrospective, naturalistic observational cohort study is to investigate the real-world safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in adults with a self-reported clinical diagnosis of anorexia nervosa (AN). The primary objective is to assess safety and tolerability by describing the type, severity, and frequency of self-reported adverse events (AEs) at 1-week post-treatment. The secondary objective is to evaluate potential effectiveness by estimating within-person change in self-reported eating disorder (ED) symptoms from baseline to 1-week post-treatment and at 1-month follow-up. Exploratory outcomes include within-person changes in self-reported body image anxiety, body appreciation, anxiety, and depression. All findings will be considered preliminary and non-causal, intended to support signal detection and inform subsequent, hypothesis-driven clinical trials.

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