The FDA on Tuesday finally gave the approval stamp to therapeutic studies regarding the drug MDMA.
FDA and Medicinal MDMA
3,4-Methylenedioxymethamphetamine, also referred to as ecstasy (or molly), is a psychoactive drug in which the user experiences increased energy, empathy, and euphoria. The effects of this drug can begin in 30 to 45 minutes if ingested orally and can last anywhere from 3 to 6 hours. It has a large variety of users from people at a Steely Dan concert to war veterans with PTSD. Therapists and scientists are interested in the latter for the time being (even if “Reelin’ In The Years” is a bop).
Early in 2019 MAPS, the Multidisciplinary Association for Psychedelic Studies, asked the federal government to do a study on MDMA treatment, mostly for patients or veterans with PTSD. However, this study was then placed on a 20 month hold by the FDA because of concerns over phase I of the test in which certain risks and credentials of the therapists were questioned. Therefore the study could not take place. But MAPS appealed this hold, citing that the researchers ability and qualifications should have been approved, while claiming the study looked promising.
MAPS disputed the hold because of an ongoing battle with the FDA in which the government administration continued to question the qualifications of MAPS researchers in other projects as well. The CEO of MAPS Public Benefit Corporation, Amy Emerson said, “This process can actually strengthen the relationship and trust between us and our review Division and ensures the Division has support on this project from the [FDA] Office of Neuroscience. This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful.”
The Future Studies of MDMA
MAPS will officially begin Phase I of this study, which will allow therapists to subject themselves to the drug for personal experience and connection. This will be used to, “measure development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients,” said a MAPS spokesperson at a press conference. Phase I is crucial to get to Phase III in which they will be testing PTSD volunteers to see if it’s a suitable solution to their problem. But as for now, obtaining personal experience with the substance is critical.
MAPS PBC Director and Head of Training and Supervision Shannon Carlin said, “This will support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers. It builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment.”
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