Potential Psychiatric Uses for MDMA
Mithoefer, M. C., Yazar-Klosinski, B.
This commentary (2016) highlights the psychiatric framework of MDMA-assisted psychotherapy, whereby the substance catalyzes the therapeutic treatment window, thus enabling processes such as psychoeducation, distress management, cognitive restructuring, emotion regulation, and interpersonal regulation to continue in the subsequent integration sessions. It also emphasizes the set and setting biological mechanisms underlying MDMA's therapeutic action, and provides recommendations to boost the credibility of researching these outcomes and mechanisms for the purposes of gaining FDA-approval.
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.