MDMA-Assisted Therapy for Moderate to Severe PTSD: A Randomized, Placebo-Controlled Phase 3 Trial

Authors: Jennifer M. Mitchell, Marcela Ot’alora G., Bessel van der Kolk, Scott Shannon, Michael Bogenschutz, Yevgeniy Gelfand, Casey Paleos, Christopher R. Nicholas, Sylvestre Quevado, Brooke Balliett, Scott Hamilton, Michael Mithoefer, Sarah Kleiman, Kelly Karjer-Guilbert, Keren Tzarfaty, Charlotte Harrison, Alberdina dr Boer, Rick Doblin, Berra Yazar-Klosinski, MAPP2 Study Collaborator Group

MDMA-assisted treatment was associated with improvements in symptoms and reductions in impairment for individuals with post-traumatic stress disorder.

Background

Many individuals with post-traumatic stress disorder (PTSD) have symptoms that persist despite participating in standard treatments, including medication and psychotherapy. 3,4-methylenedioxymethamphetamine (MDMA) is an emerging treatment option for PTSD. This study measured reported symptoms amongst individuals with moderate or severe PTSD who received MDMA or a placebo drug along with therapy.

Findings

Individuals were randomized into placebo and MDMA groups and assessed at the beginning of the study, during treatment sessions, and at 18 weeks following randomization using validated PTSD screening tools. The MDMA group had greater reductions in symptoms and in clinician-rated functional impairments across work, family, and social activities.

Program/Policy Takeaways

This study suggested that MDMA-assisted therapy may reduce symptoms and improve functional outcomes among individuals with moderate or severe PTSD. Behavioral health providers and policymakers can use the insights from this study to understand the outcomes from psychedelic-assisted treatment options.

Posted: July 2026