Summary: The Science Explorer reports on the progress of MAPS’ Phase 2 clinical trials into MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD), highlighting the upcoming Phase 3 studies that must be completed before the FDA approves MDMA as a prescription medicine. The article highlights MAPS as one of the leading organizations funding psychedelic research and educating the public about psychedelic science. “Phase 3 starts around 2017, and it will take four to five years to finish. So that will put it at early 2021 for FDA approval,” explains Brad Burge of MAPS.
Originally appearing here.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is one of the leaders behind the modern-day psychedelic research movement, and the scientists who have been heading the research into the therapeutic benefits of MDMA say that the drug could be an FDA-approved medicine in just 5 years.
In a MAPS video, Iraq war veteran Tony Macie discusses his struggle with post-traumatic stress disorder (PTSD) and experience with standard therapy versus psychedelic therapy.
Macie says he became really dependent on a lot of the medications used in standard therapy, and then he “kind of just fell off the radar.” That is, until the retired sergeant became a part of MAPS’ clinical trial which was testing MDMA as an attempt to help patients who hadn’t responded to the traditional therapies for PTSD.
So, the not-so-traditional therapy that was tested was pairing MDMA, the pure form of the illegal party drug known as ecstasy (commonly referred to as “Molly”), with psychotherapy. Importantly, most researchers note that the majority of non-research ecstasy and Molly usually aren’t pure MDMA — so indulging in the substances sold on the streets should be done at your own discretion if you know the risks.
“One of the first things I said when it kicked in was ‘this is what I’ve been looking for’,” Macie says in the video. “I reconnected with myself and did a lot of internal work, and afterwards it was like a huge weight was lifted off my shoulders.”
Macie isn’t the only one to experience such profound effects. An earlier MAPS study revealed that 83 percent of the study participants eliminated their symptoms of PTSD just two months after treatment, and these benefits stuck — long-term follow-ups conducted an average of four years later showed that the MDMA therapy had lasting effects.
The study sample only included 20 people, so it was definitely a limited size, but the promising results were enough to lead MAPS into Phase 2 clinical trials, which are the second in three sets of human trials required before the Food and Drug Administration (FDA) will consider approving a new drug.
MAPS recently announced that their Phase 2 clinical trials are coming to an end — the director of communications for MAPS, Brad Burge, told Inverse that 136 people were treated using MDMA-assisted psychotherapy for PTSD. But they haven’t yet published their results, so the exact comparisons of MDMA-assisted psychotherapy to either current treatments or a placebo are not yet available.
However, the organization says its meeting with the FDA to smooth out Phase 3 clinical trials, which would involve hundreds of people and be the final test before the FDA decides whether to approve MDMA as a new medication.
Shockingly, Burge told Inverse that MAPS believes an FDA-approval for MDMA as a therapeutic treatment could come as soon as 2021.
“Phase 3 starts around 2017, and it will take four to five years to finish. So that will put it at early 2021 for FDA approval,” he said.
It’s critical for the Phase 3 trials to show us just how safe and effective it is to use MDMA to treat PTSD, and MAPS still has a lot of fundraising to do in order to make it all happen. The organization says it needs about $20 million to complete the trials.
MAPS is also conducting research into MDMA-assisted therapy for autistic adults with social anxiety, as well as a potential treatment for the powerful anxiety associated with life-threatening illnesses like cancer.
“It’s a really interesting and a very powerful new approach,” former National Institute of Mental Health director Thomas Insel told the San Francisco Chronicle. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”
Burge says that MDMA is particularly conducive to treating PTSD because, unlike other psychedelics like LSD or mushrooms, MDMA doesn’t cause strong hallucinations or out-of-body experiences.
“With MDMA, people tend to stay more grounded,” he told Inverse. “They become more aware of the feelings that they’re having inside their body, which is very useful for psychotherapy and dealing with psychological trauma.”
It will be interesting to see how the Phase 3 trials pan out — it’s certainly wild to think that MDMA could be an FDA-approved treatment in just five years.