Within 5 years, science will likely have answered a controversial question decades in the making: can the psychoactive drug commonly known as ecstasy (3,4-methylenedioxymethamphetamine [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After positive signals in 2 small trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD)1,2 and unpublished phase 2 work, MDMA investigations are moving into phase 3.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.
Bedi G. 3,4-Methylenedioxymethamphetamine as a Psychiatric Treatment. JAMA Psychiatry. 2018;75(5):419–420. doi:10.1001/jamapsychiatry.2018.0063
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