Ecstasy from your doctor in six months? Makers of MDMA drug for trauma patients to ask FDA to approve psychedelic treatment

MDMA is close to being approved in the US after showing promise as a potent treatment for post-traumatic stress disorder (PTSD) in its final trial results.

The researchers behind the landmark trials hope to submit a new application within months for the drug, which is popular in rave culture for dancing all night and feeling more connected to music and other ravers.

In the latest trial of 53 patients with moderate to severe PTSD, 71 percent went into remission after taking the medication accompanied by therapy.

The US Food and Drug Administration (FDA) will make a decision on approving the drug to treat post-traumatic stress disorder, when combined with talk therapy, possibly as soon as six months after.

The move could offer MDMA to some of the 12 million American adults who suffer from the debilitating disorder.

Clinical trial participants received 80 mg or 120 mg of MDMA (the standard amount in a pill) plus a supplemental dose of 40 to 60 mg.

Also known as ecstasy or molly, MDMA has become part of a new frontier of psychedelics that are being repurposed as drugs for trauma and depression, along with ketamine, magic mushrooms and LSD.

If approved, MDMA-assisted therapy would be the first new treatment for post-traumatic stress disorder in more than two decades.

It has been an illegal substance since 1985, when the DEA classified it as a Schedule 1 drug, meaning the agency deemed it to have no medical use and a high potential for abuse.

Before that, hundreds of therapists are believed to have offered the drug to patients in North America and Europe to address trauma.

The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a company that develops prescription psychedelics, conducted the trials and has been advocating for the legalization of MDMA-assisted therapy since 1986.

In 2017, the FDA assigned “breakthrough therapy” to MDMA-assisted therapy as a treatment for post-traumatic stress disorder, which meant its development could be accelerated.

The latest study enrolled a total of 104 patients who had been diagnosed with moderate to severe PTSD. On average, they had lived with PTSD for 16 years.

The study group included people such as victims of childhood trauma, combat veterans, and survivors of sexual assault.

Many of them also suffered from depression and alcohol addiction.

Participants worked with two therapists and had three 90-minute preparatory talk therapy sessions followed by three treatment cycles with a one-month interval between each.

The treatment cycle involved an eight-hour experimental session in which the patient took MDMA or a placebo along with talk therapy and then had three additional 90-minute talk therapy sessions.

Some 53 patients received MDMA and 51 an inactive placebo.

The study was double-blind, meaning neither the patients nor the therapists knew who had taken what.

By the end, 87 percent of people who took MDMA had reduced symptoms, the researchers said. And about 71 percent of them improved so much that they no longer met the criteria for post-traumatic stress disorder.

In the placebo group, 69 percent had less severe symptoms and 48 percent no longer met diagnostic criteria.

The study was published yesterday in the journal Nature.

Critics of the study have said the result may not be strong enough to win FDA approval.

Dr. Allen Frances, professor emeritus of psychiatry at Duke University, told the New York Times.

“The benefits in the active group were actually not much greater than the benefits in the placebo group,” said Dr. Allen Frances, professor emeritus of psychiatry at Duke University. New York Times.

“Treatment with MDMA would add enormous costs to the treatment system and provide only a small, specific benefit, and would therefore result in a massive misallocation of already very scarce resources.”