MDMA Nears Breakthrough Approval For PTSD

Nature Medicine reported a multi-site, randomized, double-blind trial in over 100 patients with PTSD. The drug, combined with therapy, was carefully administered to patients being monitored in doctors’ offices.

Compared to patients given the same therapy with a placebo, MDMA was far more effective at dampening PTSD symptoms. Roughly twice the number of people given MDMA rather than a placebo recovered from their PTSD diagnosis.

The team repeatedly warns against seeking out the drug and taking it without supervision. The Food and Drug Administration generally requires two controlled trials before it considers approving a drug.

If the results hold up, the US may join Australia in welcoming a previously condemned drug as a new treatment for PTSD. It won’t be an easy road.

Although public and scientific opinions have shifted towards tolerance, MDMA is still listed as a Schedule 1 drug by the DEA. Drugs in this category are deemed to have “No currently accepted medical use and a high potential for abuse,” placing them alongside heroin.

Also among Schedule 1 drugs are cannabis, psylocibin, and LSD. These illicit drugs are gradually being embraced both in the research and clinical spheres as valid candidates for further study.

MDMA-an acronym for its chemical name, 3,4-methylenedioxymethamphetamine-didn’t always wear the party drug black hat.

Developed by a German pharmaceutical company to control bleeding, the drug soon caught the eye of mental health professionals.

From the 1970s to its complete ban in 1985, thousands of individual reports suggested the drug, delivered in a doctor’s office with therapy, enhanced treatment results.

The drug also leaked out onto the street around the same time, spurring a total ban by the FDA in 1985.

Convinced that research into MDMA and other psychedelic drugs shouldn’t be abandoned, he founded MAPS in 1986-a year after the ban.

For the next 40 years, his team fought to reestablish the drug as a legitimate candidate for PTSD and depression.

Neuroscientists studying drug toxicity was the norm. A prominent neuroscientist called the drug “a probe and treatment for social behaviors” in a highly prestigious journal.

In 2021, MAPS and Doblin had their first major win in a clinical trial studying 90 people with PTSD undergoing therapy, either with MDMA or a placebo.

67 percent of those receiving MDMA no longer qualified for PTSD diagnosis, compared to just 32 percent of people given placebos.

Regardless of ethnicity or race, 71 percent of people given MDMA and therapy were freed of their PTSD diagnosis, compared to 48 percent in the placebo group.

Neurologist Dr. Jennifer Mitchell at the University of California, San Francisco, who led both Phase 3 studies, told Nature that the drug acts as a “Communications lubricant.” It doesn’t make therapy sessions more fun-participants still have to work through their trauma-but it does help them more readily open up to their therapists, without experiencing shame or trauma.

They’re “Blinded” to what group the patient is in and did not administer the drug or therapy.

To Dr. Erick Turner at the Oregon Health and Science University in Portland, this doesn’t fit the FDA’s definition of “Blinding.” Even if the drug is deemed safe and efficient, regulatory agencies will still need to iron out the rules.

Because therapy is a key component but not under the FDA’s jurisdiction, the agency has to somehow dissuade people from trying the drug on their own in inconducive, or even dangerous settings.

Given MDMA’s long history, its patent is expired, reducing incentives to develop or manufacture the drug.