MDMA Therapy Is About To Disrupt Mental Health Care — Here’s How

“The psychedelic revolution is coming”

For three long decades, Rick Doblin was driving psychedelic research through his small nonprofit MAPS, the Multidisciplinary Association for Psychedelic Studies, without receiving too much attention. He founded MAPS in 1986, just a year after the FDA illegalized MDMA and put it into Schedule 1, declaring that MDMA had both a high potential for abuse and no medical value. When in fact, MDMA’s origins were not the rave drug everybody knew it to be as “Ecstasy”, but rather a drug that was initially developed for its therapeutic use.

At the ripe age of 19, Doblin — who understood and experienced this therapeutic use — decided that he would make psychedelic medicine his life's mission. He was determined to prove that psychedelics had healing potential and embarked on his journey to make them accessible to as many people as possible. For the next 30 years, he quietly and diligently pushed his MDMA research forward. In 2007, the FDA approved his plans to study LSD in conjunction with therapy — the first approved LSD project since Nixon declared the War on Drugs in 1971. To date, Doblin counts this as one of his biggest accomplishments.

But that would only be the beginning.

In May of this year, MAPS published the astonishing results of its Phase 3 clinical trials for MDMA-assisted therapy for patients with PTSD. The story made it to the cover of the New York Times, which declared that “the psychedelic revolution is coming”.

A revolution of which Doblin rightfully has become the face.

Why MDMA?

There are a variety of psychedelics that have proven some therapeutic value over the past few decades. In addition to the MDMA studies, MAPS also has an aforementioned study with LSD-assisted psychotherapy underway. And then there’s also research on medical marijuana for PTSD in veterans, as well as some offsite projects studying the “grandparent” plant medicines Ibogaine and Ayahuasca.

Other organizations like Compass Pathways are in the process of studying Psilocybin (magic mushrooms) for depression, and there are a ton of studies at universities across the globe looking into similar applications. It almost appears as if the full menu of substances is being investigated now for a wide range of impediments, ranging from PTSD to addiction, depression, eating disorders, end-of-life anxiety in cancer patients, and smoking cessation.

So why exactly is MDMA getting so much spotlight right now?

Well, primarily because it will be the first psychedelic that will cross the finish line, i.e. gain approval for therapeutic application by the FDA. Doblin was highly strategic about how he approached his research with MAPS. He knew the stakes were high, and that he needed to play his cards right in order to make it through the rigorous FDA process. He actually calls himself a “political scientist”.

There’s a couple of compelling reasons why MDMA will make it to the finish line first.

It’s much less culturally tainted than drugs like LSD. MDMA is also arguably the “easiest” psychedelic of them all. That’s another way of saying that most people will have an entirely positive experience on it, and it’s much less likely one will have a “bad trip” compared to some of the more intense psychedelics like LSD or Ayahuasca. Side note, if you’re a psychonaut, you know that “bad trips” aren’t really a thing, there are only challenging trips, and those are usually the ones that in the end will be most rewarding and bring about the most healing. But it seems that MDMA has proven that it doesn’t always have to be so painful in order to be impactful.

Under the influence of MDMA patients are able to access traumatic memories and process them with more compassion for themselves, and without being reactive or re-traumatized. With the help of experienced guidance from what is most commonly a therapist duo, this creates a container in which the patient can reframe and release whichever parts of the trauma need to go.

It’s critical to understand that psychedelics never heal people, they always “just” provide the circumstances for people to heal themselves. The professional guidance is just as important as the substance itself, which is why the MAPS protocol will exclusively be offered as an integrated program — MDMA plus therapy — once it becomes publicly available.

So how about the results? What did MAPS find that landed them on the cover of the New York Times?

When they did an intermediary evaluation, the FDA designated “Breakthrough therapy status”, so everybody knew the results had to be promising even before any data was revealed.

Then, in May of this year, MAPS published the results of its Phase 3 study: 80% of the 90 patients responded to MDMA-assisted therapy (vs. 50% in the placebo group with therapy), and of that, almost two-thirds of the patients lost their PTSD diagnosis (vs. a quarter in the placebo group) over the course of a few months.

These are undeniably strong results that should rattle even the most critical psychedelics skeptic.

What’s more is that MAPS deliberately chose the most severe PTSD patients for its Phase 3 studies: high rates of suicidality, patients that had been diagnosed for an average of 14 years, and a high rate of comorbidities such as depression (which was prevalent in over 90% of study participants).

That is to say, if one were to replicate this on a larger scale with a wider range of patients, it’s likely that efficacy results would be even more impressive.

Why PTSD?

As mentioned previously, there’s a host of mental illnesses for which psychedelic medicine holds promises.

Why did MAPS narrow down on PTSD?

At first sight, it seems that diagnoses like major depression could be even more relevant since the patient population is vastly larger.

One reason is that PTSD patients are a patient group that virtually everyone sympathizes with. Before looking into it, I had actually assumed that the majority of the PTSD patients in the study were veterans. Politically that would make a lot of sense. After all, the end goal is to legalize these substances, which only our government can do. And veterans are a population dear to our government’s heart.

But turns out, only 12% of the Phase 3 patients were combat veterans. The large majority (84% to be precise) suffered developmental, i.e. childhood trauma, which can be anything from physical to sexual abuse during our most formative developmental years. Sadly, even more people would be able to relate to that.

Given the prevalence of childhood trauma in its study, MAPS is actually keen to conduct further research with a younger patient population (the average age in Phase 3 trials was 41 years). Obviously, it would be even more impactful to receive this treatment closer to when the trauma occurs. It could save patients years and years of suffering.

Finally, and that’s not something that MAPS is communicating but rather a personal hypothesis I’m inserting here, there’s a strong belief in the psychedelic community that many of our physical and mental ailments are the result of trauma. Dr. Gabor Mate, a world-renowned trauma expert, has populated the thesis that trauma is the root cause of all addiction and openly shares insights from his work with Ayahuasca — which proves his thesis.

In fact, the likelihood that one will revisit some kind of trauma, independent of the magnitude, during any deep psychedelic journey is extremely high. It’s precisely what makes these experiences so healing. They help us reveal or revisit what we locked up, our deepest, darkest wounds, and surface what we’re not willing to see, subsequently helping us to let go of that which is causing our suffering.

So if we look at the question of whether trauma is at the root of many mental health disorders, focusing on PTSD for psychedelic research is brilliant.

Because not all trauma will appear in the form of diagnosable PTSD.

If I take my own experience for example, where my trauma manifested as bulimia and depression, it becomes evident that PTSD is only one possible aftermath of trauma. There is also addiction, depression, eating disorders, and several others. I never had classic PTSD symptoms, but it was most certainly trauma that was causing my mental illnesses.

So if we believe the trauma theory (and that’s something researchers still have to scientifically prove with large-scale studies), then the MAPS findings are laying the groundwork in an even more fundamental way than initially thought.

Why Now?

Well, it’s time. The mental health care epidemic has been raging out of control for several years. 1 in 5 adults in the US experience mental illnesses each year, and suicide is the second leading cause of death among people aged 10–34. Anxiety disorders are the most common issues, with almost 20% of adults suffering every year. This is followed by major depressive disorder, which is experienced by an astounding 8% of adults in the US. Around 4% of adults suffer from PTSD, and another 3% from bipolar disorder

Additionally, we’re now facing the aftermath of a global pandemic that — if we look to history — will further worsen our mental health, even long after it has passed.

In parallel, the legalization of Cannabis across several states has proven “successful”, at least financially for the governments that are pocketing large sums of cash through taxes, and culturally for the citizens that are celebrating their freedom. Local “decriminalize nature” movements across the country are gaining momentum. Denver, Colorado legalized hallucinogens in May 2019, Santa Cruz and Oakland in California followed suit in July 2019 and January 2020, respectively. Washington D.C. decriminalized psychedelic plants in November 2020. And in December last year, Oregon became the first state to decriminalize all psychedelics. California is set to follow suit, clearing another committee in June of this year.

More and more public media figures are speaking out, podcast heavyweights Joe Rogan and Tim Ferris are vocal about their psychedelic endorsements, former NBA player Lamar Odom just released a documentary about his healing journey with Ibogaine, and Hollywood actresses Gwyneth Paltrow and Kristen Bell publicly talk about the healing powers of magic mushrooms.

There’s still a long way to go, and a significant amount of stigma to break, but the path looks promising: backed with bulletproof research results, large amounts of capital, and an increasing number of public support from influential individuals.

So What’s Next?

MAPS is in the process of setting up its second confirmatory Phase 3 study, which it hopes to complete by 2022. If all goes as expected, the FDA may approve the treatment as soon as 2023. MAPS is gearing up for rolling out its novel MDMA therapy, which, once legalized, will be the first-ever psychedelic therapy involving a then former Schedule 1 drug.

In the meantime, savvy entrepreneurs are beginning to build out the infrastructure required to provide access to these treatments. Psychedelic clinics like Fieldtrip are opening up across the country to treat patients with Ketamine, a Schedule 3 compound that’s commonly referred to as a “dissociative” psychedelic, used to treat primarily depression. Eventually, these clinics plan to offer the full range of compounds and treatment specialties, including, of course, MDMA-assisted therapy for PTSD.

Investors are flooding psychedelic start-ups with cash, pouring millions into further psychedelic research. More and more universities are getting involved.

Everyone is getting ready.

And the whole (psychedelic) world is watching.

Because once these novel therapies hit the market, as articulated by the New York Times, psychiatry may never be the same.

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