Potential Psychiatric Uses for MDMA
Bb Yazar‐klosinski, Mc Mithoefer
Clinical Pharmacology & Therapeutics November 10, 2016 DOI: 10.1002/cpt.565 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | MDMA |
| Keywords | MDMA-Assisted Psychotherapy PTSD Treatment Mental health innovation Regulatory pathways |
| Citations | 81 |
| Key findings | Phase II trials demonstrate initial safety and efficacy of MDMA-assisted psychotherapy for PTSD, with potential for treating depression and anxiety disorders. |
Abstract
Phase II trials of 3,4‐methylenedioxymethamphetamine (MDMA)‐assisted psychotherapy have demonstrated initial safety and efficacy for treatment of posttraumatic stress disorder (PTSD), with potential for expansion to depression and anxiety disorders. In these trials, single doses of MDMA are administered in a model of medication‐assisted psychotherapy, differing from trials involving daily drug administration without psychotherapy. This model presents an opportunity to utilize accelerated regulatory pathways, such as the US Food and Drug Administration (FDA) Breakthrough Therapy Designation, to most effectively and expeditiously test such novel approaches.