3,4-Methylenedioxymethamphetamine as a Psychiatric Treatment

Abstract

Within 5 years, science will likely have answered a controversial question decades in the making: can the psychoactive drug commonly known as ecstasy (3,4methylenedioxymethamphetamine [MDMA]) be used to treat psychiatric disorders? After positive signals in 2 small trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) 1,2 and unpublished phase 2 work, MDMA investigations are moving into phase 3. Moreover, MDMA-assisted psychotherapy has obtained the breakthrough therapy designation of the US Food and Drug Administration (FDA), which is intended to expedite development and review of novel, potentially effective treatments. The nonprofit organization coordinating this research, the Multidisciplinary Association for Psychedelic Studies (MAPS), estimates that phase 3 studies enrolling at least 200 participants will be completed by 2020, with a new drug application submitted to the FDA shortly thereafter. Of importance, the phase 3 protocols have undergone FDA special protocol assessment, increasing the chances of rapid approval in the event of positive results. Thus, MDMA may be approved for prescription by 2021, necessitating consideration of several important regulatory and clinical issues. Herein, I provide an overview of MDMA-assisted psychotherapy and key associated questions from the viewpoint that these issues need to be considered by psychiatry beyond the small community of MDMA therapy advocates.

Diminished positive affect and traumatic stress: A biobehavioral review and commentary on trauma affective neuroscience

“…This treatment modality has been designated as a “breakthrough therapy” by the Food and Drug Administration (FDA) and has been fast-tracked for approval as an FDA-approved treatment for treatment-resistant PTSD. It is currently being tested in Phase 3 clinical trials ( Bedi, 2018 ). Unlike existing paradigms for chronic dosing of medications in treating psychiatric disorders, MDMA-assisted psychotherapy adopts the classic psychedelic-assisted psychotherapy model ( Pahnke et al, 1970 ), wherein therapeutic change is effected through 2 to 3 long, high-dose drug psychotherapy sessions with preparatory therapeutic sessions beforehand and integration sessions afterwards.…”

Greater empathy in MDMA users

“…In line with evidence of serotonergic dysfunction from earlier studies of MDMA, it was hypothesised that chronic MDMA use would reduce empathic processes and heighten sensitivity to social pain, compared with non-MDMA poly-drug users and alcohol-only users. However, given recent findings (Wunderli et al, 2018) and suggestions from recent reviews (Bedi, 2018), it may also be possible that empathy increases and there is a reduction in social pain with repeated MDMA use.…”

The Role of Psychedelic Agents in Treatment of Mood Disorders and Addictions: A Clinical Conversation with Scott Shannon, MD, and Robert Rountree, MD

“…There was a recent editorial in JAMA Psychiatry looking at the data from the phase 2 studies of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD), 4 and they said if this pans out, we may be looking at the first pharmaceutically mediated cure in psychiatry, and that we treat people with PTSD with MDMA-assisted therapy for three sessions, and a high percentage of them no longer have PTSD and do not need any kind of ongoing maintenance or pharmacology.…”