FDA approves trials to treat PTSD with ecstasy

The Food and Drug Administration authorized the use of MDMA in large-scale clinical studies, according to The New York Times.

The approval comes after small studies showed proof the drug, also known as the party drug ecstasy, might be effective in treating post-traumatic stress disorder (PTSD).

The Multidisciplinary Association for Psychedelic Studies, a small not-for-profit organization established in 1985 to promote the lawful medical use of illicit substances, sponsored six Phase 2 analyses treating 130 PTSD patients with MDMA. It will also fund the Phase 3 study, which will include 230 patients or more.

Studying MDMA for Medical Purposes

Two of the trials enlisted combat veterans, sexual assault victims and first responders with PTSD who had not resolved their issues via traditional prescription medications or psychotherapy. Patients had struggled with their symptoms for 17 years, on average.

The preliminary trials involved three doses of MDMA given with a psychiatrist’s direction. Researchers found a 56 percent average decrease in the reported severity of symptoms. By the conclusion of the study, two-thirds of participants didn’t meet the standards for having PTSD. Follow-up exams showed changes more than a year after therapy.

During primary research studies, patients underwent 12 weeks of psychotherapy, including three eight-hour sessions where they took MDMA. During these times, they laid on a mattress in the middle of candles and fresh flowers, while listening to calming music.

mdma pills on an black background

The drug has often been used for illicit purposes, but researchers think there is real value in MDMA (Credit: Thinkstock)

Research has shown the drug triggers the release of chemicals that stimulate feelings of trust, adoration, and well-being, while also blocking fear and adverse emotional memories that can be overwhelming in people with PTSD. Study participants said MDMA gave them increased clarity and capability to confront their issues.

In interviews, study volunteers said MDMA therapy not only assisted them with agonizing memories, but also kept them from abusing alcohol and other drugs, helping some to put their lives back together.

The scientists are so confident in their results; they have requested breakthrough therapy status from the FDA, which would accelerate the approval process. If approved, the drug might be available by 2021.

Researchers’ proposal calls for the drug to be used a limited amount of times in the presence of qualified psychotherapists together with a broader therapy regimen. However, even in those controlled circumstances, approval of the drug could encourage more unlawful recreational use.

—–

Image credit: Thinkstock