A Review of MDMA-Assisted Therapy for Posttraumatic Stress Disorder.
Benjamin R. Lewis, Kevin Byrne
Focus July 1, 2023 DOI: 10.1176/appi.focus.20220088 (opens in new tab)
Study at a glance
AI-extracted from the abstractAbstract
Posttraumatic stress disorder (PTSD) is a common chronic and disabling psychiatric disorder that may develop after exposure to a traumatic life event. There are existing evidence-based psychotherapies and pharmacotherapies for PTSD; however, these treatments have significant limitations. 3,4-methylenedioxymethamphetamine (MDMA) was granted "breakthrough therapy" status by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of PTSD in conjunction with psychotherapy after preliminary Phase II results. This treatment is currently being investigated in Phase III trials with anticipated FDA approval of MDMA-assisted psychotherapy for PTSD in late 2023. This article reviews the evidence base for MDMA-assisted psychotherapy for PTSD, pharmacology and the proposed causal mechanisms of MDMA, risks and limitations of the current evidence, and challenges and future directions for the field.
Comparable studies
Other narrative reviews on MDMA for PTSD, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA. | 2016 | Review | |
| MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms? | 2018 | Review | |
| Clinical applications of hallucinogens: A review. | 2016 | Review | |
| MDMA‐Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta‐Analysis | 2021 | Review | |
| Registered clinical studies investigating psychedelic drugs for psychiatric disorders. Registered clinical trials on clinicaltrials.gov evaluating psychedelics for... | 2021 | Review | n = 70 |
Citations in the library
Cited by 9
- Effects of 3,4-methylenedioxymethamphetamine on the gut microbiota and metabolites in the small intestine, cecum, and colon of male rats. Progress in Neuro-Psychopharmacology and Biological Psychiatry January 10, 2025
- Mapping cognitive-behavioral approach in psychedelic-assisted treatment: a systematic review across phases with classic and non-classic psychedelics European Archives of Psychiatry and Clinical Neuroscience March 28, 2026
- Policy Considerations for Psychedelics in Research and Medicine – What’s Next on the Schedule? Journal of Science Policy & Governance July 2, 2026
- A repeated low-dose regimen of MDMA has transient next-day effects on locomotor activity, anxiety-like behavior, and brain serotonin levels, with no effect on anhedonia-like behavior, in both female and male rats Psychopharmacology March 4, 2026
- MDMA-Assisted Therapy for PTSD: Neuroplastic Change or Psychotherapeutic Catalyst? Translation The University of Toledo Journal of Medical Sciences February 17, 2026
and 4 more in the library
Cites 50
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- Differences Between the Mechanism of Action of MDMA, MBDB, and the Classic Hallucinogens. Identification of a New Therapeutic Class: Entactogens Journal of Psychoactive Drugs October 1, 1986
- Human Pharmacology of MDMA Therapeutic Drug Monitoring March 19, 2004
- MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology September 1, 2019
and 45 more in the library