CLEVELAND — In the last decade, research has exploded regarding psychedelic drugs to treat mental health disorders. Now, MAPS Public Benefit Corp. is asking the Food and Drug Administration to approve MDMA — in combination with intense psychotherapy — to treat post-traumatic stress disorder.
It's the first, but it won't be the last, to go before the FDA requesting approval.
Cleveland Clinic psychiatrist Dr. Brian Barnett, who works in the Center for Adult Behavioral Health, earlier this year conducted research into using LSD to treat general anxiety disorder. On Thursday, MindMed released preliminary findings of that research showing it helped more than a placebo.
Barnett believes the FDA will approve MDMA because of the extensive research it has undergone and the positive results it has shown. He expects it to be signed off on possibly in about six months.
While approval is not guaranteed, if it does happen, there may be several strings attached.
These drugs are not meant for patients to take at home; they are delivered in controlled environments and followed by intensive psychotherapy sessions. They are also given by highly trained mental health professionals who understand how psychedelics work, and typically, there must be two supervising the patient at all times.
While the FDA could potentially approve the drug, it doesn't regulate how it's prescribed. That will be up to state licensing boards. Another issue is there aren't enough trained mental health professionals available to even give the therapy.
Last year, the Ohio State University opened the Center for Psychedelic Drug Research and Education, and is trying to address the issue of training professionals. Currently, they're researching whether psilocybin — also known as magic mushrooms — can help those suffering from PTSD. It's already been shown to help those suffering from depression in previous studies, but is not yet approved by the FDA.
Barnett expects an application will be filed in the next year or two for psilicybin depression therapy.