Study Moves Therapeutic Use of MDMA Toward FDA Approval

The party drug MDMA has earned positive results for treating people living with post-traumatic stress disorder, according to a new government study that confirms other findings.

A new study on the MDMA clinical trial program was completed in November and sponsored by a group called the Multidisciplinary Association for Psychedelic Studies. The trial is part of an ongoing effort to gain federal approval for MDMA’s therapeutic use as the number of people suffering from PTSD, mental illness and opioid addiction continues to rise.

Before the federal criminalization of MDMA use and possession in 1985, the substance had been used legally in therapeutic treatments for at least a decade. As part of its decision to criminalize MDMA, the Drug Enforcement Administration said abuse of the substance “has become a nationwide problem” and poses a “serious health threat.”

MDMA is just one of several drugs, particularly psychedelic drugs, that the federal government considered mainly for recreational purposes—and therefore illegal—that are now slowly moving toward government approval for legal use. Drugs, including psilocybin, found in “magic mushrooms,” are being studied for therapeutic use.

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The Biden administration has signaled a willingness to explore the potential of using criminalized substances to address a growing national mental health crisis, and officials in Congress have undertaken a bipartisan effort to ease access to federally banned substances for therapeutic use. The Multidisciplinary Society for Psychedelic Studies’ latest clinical research on MDMA is a phase 3 study that aims to eventually win approval from the Food and Drug Administration.

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The stigma against psychedelic and psychoactive drugs and the residual effects of President Richard Nixon’s “war on drugs” have stalled progress in one of the few areas of drug policy on which there is significant bipartisan consensus.

In May, the Department of Health and Human Services said it predicted the FDA would approve both MDMA and psilocybin for the treatment of PTSD and depression, respectively, within the next two years. President Joe Biden’s administration has supported the creation of a federal task force to investigate potential problems with psychedelic and entactogenic drugs. The White House did not immediately comment on the status of the task force or efforts to obtain FDA approval for either substance.

In July, Sens. Cory Booker, DN.J., and Rand Paul, R-Ky., introduced a bill that would give people with terminal illnesses access to drugs classified under Schedule I of the Controlled Substances Act that passed clinical phase one trial, but have not yet received FDA approval. The bill was supported by the Veterans Leadership Coalition on Mental Health, which includes several organizations working to prevent suicide and despair deaths among veterans and non-veterans. The bill was referred to the Senate Judiciary Committee on July 20. (Spokesmen for Booker and Paul did not immediately respond to a request for comment.)

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Last summer, the house also moved to expand research into psychedelic therapy. Representatives Alexandria Ocasio-Cortez, DN.Y. and Dan Crenshaw, R-Texas, offered amendments to the annual National Defense Authorization Act that would ease federal restrictions on the use of psychedelic treatments for veterans and active-duty service members struggling with mental illness.


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