SCIENCE
10/20/2015 04:30 pm ET Updated Oct 20, 2015

MDMA Psychotherapy Could Be Legal In Just Five Years

FDA approval of the treatment for PTSD is on the horizon.
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If you think of MDMA, the drug often cut with other substances and sold as "Molly" or Ecstasy, as just an illicit party drug, think again. A growing body of research suggests that it and other psychedelic drugs can be effective treatments for ailments ranging from post-traumatic stress disorder to social anxiety in autistic adults. And one of the leading proponents of MDMA-assisted psychotherapy suggests the drug could be legally available sooner than might you think.

“We’re on track for MDMA to be approved by the FDA by 2021,” Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, said at the Horizons: Perspectives on Psychedelics conference in New York on Oct. 10. “We are in a pretty good place for reaching this goal.”  

In order to make this happen, MAPS has undertaken an ambitious $21 million plan to fund clinical trials and train psychotherapists. 

Here's how it works: MDMA is an empathogen, which means it stimulates areas of the brain associated with feelings of love, connection and empathy. When used under the guidance of trained clinicians, it can allow patients with PTSD to explore traumatic memories in a safe, nonthreatening way.

"Really, it’s MDMA-assisted psychotherapy," Doblin explained. "That’s the treatment -- it’s not just the MDMA by itself. This provides a lot of extra support and safety through the whole process."

In the first clinical trial for MDMA-assisted psychotherapy for PTSD, 83 percent of patients no longer showed symptoms of the disorder after just two sessions. 

The Huffington Post chatted with Doblin about the future of MDMA psychotherapy and the long road to making psychedelic-assisted therapies a legal treatment option for people suffering from mental illness. 

You've outlined an ambitious plan to make MDMA-assisted psychotherapy legal by 2021. How do you expect this to happen? 

We’re now wrapping up the Phase 2 series of pilot studies that we started in 2000, which was the first time that we were able to work with MDMA with a patient population. In just a few months, we’re going to complete treating over 100 PTSD patients. The most crucial transition -- the movement from Phase 2 to Phase 3 studies on MDMA for PTSD -- is happening in the next year.

[Editor's note: Phase 2 trials are when the drug is given to a larger group of people than in the initial trial to monitor its effectiveness and safety. Phase 3 trials are used to confirm efficacy, further evaluate side effects and determine usage guidelines.]

By late 2017, we anticipate that we’ll have come to an agreement with the FDA on the design of Phase 3. Then, we have four years or so to complete Phase 3 trials on roughly 400 subjects, which will cost around $21 million. We have half of the money pledged or raised already, so we’re hopeful.

Of course, we also have to train a whole new generation of therapists. We have a training program taking place as we speak, with 15 people in Charleston, South Carolina, training to become MDMA/PTSD psychotherapists.

What happens next? 

We hope to continue to get MDMA approved for other uses [such as end-of-life anxiety and social anxiety in adults with autism]. Other organizations will hopefully also get psilocybin [the psychoactive ingredient in hallucinogenic mushrooms] approved for therapeutic uses.

In another five years, we hope to set up psychedelic clinics. What we’re talking about with these psychedelic clinics is the model of the hospice center. In 1974 the first hospice was built, and today there are 3,500 in America. After the FDA approval, we anticipate that the next decade will see the rollout of these clinics.

(Story continues below photo.) 

Doblin gives a presentation on MDMA-assisted psychotherapy for PTSD at the 2015 Horizons conference in New York City. 
Steve Duncan
Doblin gives a presentation on MDMA-assisted psychotherapy for PTSD at the 2015 Horizons conference in New York City. 

What are researchers finding in the clinical trials looking at MDMA for treating social anxiety in adults with autism?

We only have data on eight out of the 12 participants so far, but the findings are pretty remarkable. We’re finding that it works, but we’re also not totally surprised.

The reason we started looking at this was because there were a number of people who had diagnoses of being on the autism spectrum who posted stories on the Internet about how taking MDMA in party settings helped their social anxiety.

Where do you still see resistance to the use of psychedelics in mental health care? What are some of the more common misconceptions about psychedelic therapy?

People have been given a sense of incredible danger around these drugs. The way it’s been presented is that you take a single dose and you’ll have major brain damage and significant consequences. We haven’t found that in clinical settings at all, and I think it’s been exaggerated in other contexts.

Some people also have the misconception that they’ll do MDMA in the therapy setting, and then they’ll become addicted and want to do it all the time. We don’t see that happening either.

When someone is able to let go of their normal sense of controlling their emotion or not feeling things or pushing things down, an astonishing type of healing can take place.

Another part is the idea that these drugs make you lose control and that this is what’s really dangerous. But in fact, we’re seeing that keeping things in control is often what’s keeping these disorders from getting healed. When someone is able to let go of their normal sense of controlling their emotions or not feeling things or pushing things down, an astonishing type of healing can take place.

Would MDMA-assisted psychotherapy also be helpful for a general population -- not just patients with PTSD? Could this be a reality one day?

The challenge of working with the FDA and working within the medical model is that you’re only able to create drugs that treat recognized diseases. Couples therapy is one of the best uses of MDMA, and it’s been used that way a lot to help their relationships. But that’s not a disease, so we’ll never be able to get couples therapy approved by the FDA as one of the legitimate uses of MDMA by prescription.

I think there are enormous benefits outside the medical model to treat people who don’t have a specified disorder -- potential of psychedelics like LSD and MDMA to be used for spiritual experiences and personal growth.

This interview has been lightly edited for length and clarity. 

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