MDMA Moves Closer to FDA Approval, Thanks to UCSF-Led Project

A just-published study led by a UCSF neurologist and psychiatrist shows that MDMA is safe and effective for treating PTSD, and efforts are underway to get the hallucinogen FDA approval for legal, medical use.

Those of you who follow narcotics news are probably well aware that state senator Scott Wiener’s bill to decriminalize magic mushrooms, DMT, and mescaline has passed the state legislature, and is currently sitting on Gavin Newsom’s desk and hopes to a signature. But that bill would only decriminalize those substances, not legalize them. While legalization may be on the horizon for MDMA, commonly known in the clubs as molly or ecstasy, because a newly released study shows its effectiveness in the treatment of PTSD, according to the Chronicle.

And the lead researcher on that just-published paper is a UCSF neurologist and psychiatrist, Dr. Jennifer Mitchell. The study could help pave the way for MDMA, which has been illegal since 1985, to gain full FDA approval for the medical treatment of post-traumatic stress disorder (PTSD).

The study on MDMA treatment for PTSD was published Thursday in the scientific journal Natural medicinewho published the entire study online for free, not just the abstract.

The study had 104 subjects with PTSD, both veterans and people who lived through severe natural disasters. And it used a placebo group (that didn’t get the drug), and found that 71% of the MDMA group lost their PTSD symptoms with therapy, while only 48% of the placebo group lost their symptoms with therapy could shake

“These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated,” the study concludes.

Hi, where do I sign up for one of these clinical trials?

I kid, because PTSD is a serious disorder, and one that is difficult to treat with regular antidepressants and conventional therapy. But MDMA causes the human brain to release serotonin and oxytocin, stimulating neurotransmitters that facilitate bonding, empathy and a sense of joy. And this study may help pave the way for the FDA to approve MDMA as a clinically effective, safe treatment for those who have experienced severe trauma and whose brains have not recovered.

“This is basically the last step before asking the FDA for approval, which is a huge landmark in mental health treatment,” Mitchell told the Chronicle. “That opens the door to a new type of therapy.”

But that approval is not a slam dunk. Researchers who are not involved in the study point out that the “controlled environment” offered to the subjects of this study would be difficult to replicate with large-scale use. Moreover, insurance companies are unlikely to be receptive to subsidizing molly in their coverage.

Barring those drawbacks, we could theoretically see FDA approval specifically for treatment of diagnosed PTSD as early as next year. The organization Multidisciplinary Association for Psychedelic Studies, which was involved in this study, plans to submit an application at the end of 2023.

Related: Test Confirms San Francisco’s Molly Is Better Than New York’s (SFist)

Image: MDMA or Ecstasy pills on dust background (Getty Images)