FDA Designates MDMA a Breakthrough Therapy for PTSD
By Heather Callaghan, Editor
Is the FDA paving the way to get ecstasy at the doctor’s office?
No, this is not satire. Last week, the Multidisciplinary Association for Psychedelic Studies (MAPS) gave a press release stating that the FDA actually granted “Breakthrough Therapy Designation” to MDMA for the treatment of post-traumatic stress disorder (PTSD).
But this is news that many young adult ravers could have informed the government. In case you don’t know, MDMA which stands for methylenedioxymethamphetamine, is the main ingredient in Ecstasy, the popular but illegal drug associated with raves, dancefloors, lights and euphoria.
By granting Breakthrough Therapy Designation, the government is essentially agreeing that this treatment “may have a meaningful advantage and greater compliance over available medications for PTSD” and is fast-tracking it for approval to treat post traumatic stress.
MAPS notes that the trials will involve MDMA-assisted psychotherapy as a novel treatment package that combines psychotherapeutic techniques with three administrations of “MDMA as a pharmacological adjunct.”
The drug’s ability to help PTSD-sufferers cope with the lingering effects of trauma is attributed in large part to its capacity to produce feelings of euphoria, empathy, and heightened emotional and physical sensations–in other words, perhaps, giving sorely stressed brains the kind of neurochemical getaway that begets a little peace of mind. Those effects also seem to motivate recreational users, but unlike the self-dosed Saturday night version, official MDMA-assisted psychotherapy involves three administrations of the drug combined with established psychotherapeutic techniques.
In Phase 2 trials completed by MAPS, 61% of the 107 participants no longer qualified for PTSD two months after they underwent three sessions of MDMA-assisted psychotherapy, according to the group. After a year, that number grew to 68%, and among participants who had all suffered from chronic, treatment-resistant PTSD, on average for 17.8 years.
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS.
Trials are planned for next spring and could be done by 2021 if MAPS is able to provide around $25 million for the trial.
Doblin told the London conference that he believed MDMA was the “most likely” psychedelic to be adopted by psychiatric and psychotherapy professionals. “MDMA is the most gentle of all the psychedelics,” he said.
This is not the first time club drugs or psychedelics were noted scientifically for their effects on depression. Another popular club drug being used for depression is ketamine and it, too, is being recognized medically. Ketamine, similar to cannabis, doesn’t really have an overdose threshold, at least not one that is practical to reach – unlike deadly opioids and antidepressants. Therefore, it really doesn’t make sense to lock anyone up in a cage over the use of these drugs when, clearly, the government knows they can produce positive effects and has led people to take fatal drugs for generations.
Meanwhile, medical interest in psychedelics has skyrocketed in recent history like never before. Magic mushrooms, ayahuasca, LSD and more are raising scientific eyebrows especially when it comes to the effects of these substances on depression.
David Nutt, a neuropsychopharmacologist at Imperial College London, commented to Science about the MDMA breakthrough saying, “This is not a big scientific step … It’s been obvious for 40 years that these drugs are medicines. But it’s a huge step in acceptance.”
We hope that MAPS finds those funds as they have been dedicated to this research for over three decades. We hope MDMA doesn’t become polished up by Big Pharma simply to become the new bandage for depression. We fully support the scientific breakthroughs, however, that discover how the effects of recreational drugs work to help people suffering from PTS and depression, and we certainly don’t wish to see them in prison for trying to find what helps them.
DISCLAIMER: This article is not intended to provide medical advice, diagnosis or treatment.