Ecstasy (MDMA) Moving Through FDA Approval Process for PTSD

By Debbie Gregory.

The active ingredient in the drug ecstasy, MDMA, is set to be studied in large-scale clinical trial as a treatment for people with post-traumatic stress disorder (PTSD.)

The U.S. Food and Drug Administration (FDA) has reviewed the use of MDMA, better known as the illegal drug ecstasy (or Molly) in the treatment PTSD.

Researchers at the Psychedelic Science 2017 conference in Oakland, California presented the results from trials involving the treatment of 107 people diagnosed with PTSD. The FDA has recommended that the researchers move forward with the next phase of the trials, the final stage before potential approval of the drug.

About 8% of the U.S. population will experience PTSD at some point in their lives.

“The results I’ve seen so far with MDMA are so much better than anything I’ve seen so far,” said Michael Mithoefer, a psychiatrist in Charleston, South Carolina, and a principle investigator in the MDMA trials.

As early as the 1990s, scientists showed that MDMA was reasonably safe when taken a few times in a controlled setting. The FDA permitted researchers to move forward with clinical trials exploring the drug as a treatment for PTSD.

Researchers believe that MDMA reduces the fear response and triggers the release of serotonin and other neurotransmitters that induce a feeling of well-being.

“MDMA provides a sweet spot where therapeutic change can happen,” says Mithoefer. “It affects neural networks so that people’s experiences are not hijacked by fear.”

Researchers hope to expand the enrollment of up to 300 people with PTSD to participate in the upcoming phase III trials.

The researchers will spend this year training therapists from 14 clinics across North America and Israel to deliver the MDMA-assisted psychotherapy.

The non-profit organization that is sponsoring the trials, Multidisciplinary Association for Psychedelic Studies (MAPS), is also sponsoring trials studying MDMA’s effects on social anxiety in adults with autism.

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