FDA Highlights Concerns About Research Investigating MDMA as PTSD Treatment

The U.S. Food and Drug Administration (FDA) on Friday posted its initial review of the hallucinogen MDMA, commonly known as molly or ecstasy, which highlights concerns about the substance’s potential health effects when used as a treatment for post-traumatic stress disorder (PTSD), the New York Times reports.

The FDA — which granted MDMA a “breakthrough therapy” designation in 2017, fast-tracking its research process — said initial research results were potentially flawed due to imperfections in the research process. Specifically, the agency suggested it would be too easy for the study’s participants and therapists alike to determine who had been given MDMA versus a placebo, which would create bias, the report said. The agency also noted “significant increases” in blood pressure and the increased potential for “cardiovascular events” as potential points of concern.

MDMA is currently registered as Schedule I under the Controlled Substances Act, which is supposed to be reserved for only the most dangerous and addictive drugs with “no currently accepted medical use and a high potential for abuse.”

If the drug is approved as a treatment for PTSD, it would be the second monumental shift in federal drug policy in recent times after the Biden Administration announced earlier this year cannabis would be moved from Schedule I to Schedule III. It would also be the first new therapy approved for the treatment of PTSD in more than 20 years.

The FDA released its draft rules for the research of psychedelic drugs in June.

Meanwhile, Australia last year legalized medical MDMA and psilocybin — the naturally occurring psychedelic ingredient in hallucinogenic mushrooms — as treatments for PTSD and depression, respectively.