It’s been widely reported that MDMA is demonstrating profound results for the treatment of post-traumatic stress disorder. The research, sponsored by MAPS (the Multidisciplinary Association for Psychedelic Studies), is currently undergoing Phase 3 Trials, the final phase of double-blind, placebo-controlled data collection before FDA approval. Phase 2 results were so promising that in 2017, the FDA designated MDMA a “breakthrough therapy,” meaning they’re working closely with MAPS for optimal Phase 3 efficiency, potentially expediting legalization.
Phase 3 Trials are currently underway in Canada, Israel, and 10 U.S. cities — including Fort Collins, CO.
Dr. Scott Shannon is leading the Fort Collins studies at The Wholeness Center, a treatment center he founded 2010 that focuses on “treating the whole person through body, mind and spirit.” He’s quite familiar with MDMA’s therapeutic value, for in the early 80s, after his undergrad advisor Andrew Weil cued him into MDMA’s remarkable benefit, Dr. Shannon began incorporating it into his practice.
“I saw phenomenal benefit to MDMA,” Dr. Shannon said, “typically for doing couples work, relationship work, and helping people deal with trauma and difficult experiences.”
But alas, MDMA grew a reputation as a dangerous party drug, and in 1985, the DEA made it a Schedule I drug, right up there with heroin. When they scheduled it, the DEA received significant pushback from therapists across the world — Harvard psychiatrist Lester Grinspoon sued them, claiming they ignored MDMA’s medical value. Nevertheless, amidst Nancy Reagan’s “Just Say No” campaign, the feds closed the doors.
Dr. Shannon remained aware of Rick Doblin’s work with MAPS — started in 1986 — but his interest grew peripheral as he directed his life toward holistic integrative medicine and raising a family.
“Then about four or five years ago, I found out that MAPS was doing trials with MDMA,” Dr. Shannon said. “ When I heard they were looking for Phase 3 sites, I applied and got selected. Now, I’m the Principal Investigator for Fort Collins.”
For Dr. Shannon, things have indeed come full circle.
Rooster Magazine recently met with Dr. Shannon — a calm, compassionate man with a focused gaze and noteworthy mustache — to learn about MDMA-Assisted Psychotherapy for the treatment of PTSD and what the future may hold for this seemingly-miraculous development in psychotherapy land.
Is MDMA the same thing as “molly” and “ecstasy”?
Molly and ecstasy may contain MDMA, or may not. They may be mixed with other things, they may not. In our study, we know what we’re getting, so we tell people MDMA is not the same as molly and ecstasy.
Those are just catch-all street terms?
Yes. It’s important to make that distinction. Just because your friend says its ecstasy doesn’t mean it’s pharmaceutically-pure MDMA.
What are the current treatments for PTSD?
At this point, it’s trauma-based CBT — a talk therapy —, EMDR — Eye Movement Desensitization and Reprocessing —, or it’s SSRIs, like Zoloft. Those are helpful, but they’re often not helpful for people with severe illness. And often, particularly with the medications, the results fade over time.
Whereas with MDMA, long-term healing is being shown.
Yes. The Phase 2 trials showed that with 107 people, two months after their third MDMA-assisted psychotherapy day, 56% no longer met criteria for PTSD. A year after that, 68% no longer met criteria. What that shows is that people tend to continue to get better over time, which is unlike what we see with medications, where the results tend to fade.
These MDMA sessions seem to be a therapy of confronting difficult trauma.
That may be accurate. But what I see happening is people digest the experiences that they’ve had. MDMA quiets down the amygdala — the fear center of the brain — enough that people can actually reason through their experience and understand that they survived it, that it’s not an acute issue for them anymore and they’re going to be okay.
If you and I were to experience a stressful event — traumatic, but not overwhelming — it would be difficult for a few days. In a month, it would be much less difficult. In a few years, we’d probably forget about it. For people with PTSD, it’s an overwhelming situation, which sort of breaks a circuit, and they go into overload. They tend then to live in fear and trauma, reexperiencing it without being able to thoughtfully digest it and put it behind them.
With MDMA, they’re able to do that. They may go back and experience more memories — sometimes they’re confronting things — but it’s more of a loving and supporting therapy process than one of confrontation.
What does the therapy look like?
There’s three prep sessions, MDMA Day 1, three sessions, MDMA Day 2, three sessions, MDMA Day 3, and three integration sessions to follow up. It takes five months overall.
After the three prep sessions, people are screened to make sure they don’t have high blood pressure, heart disease, or any number of problems. People have to wean off most, if not all psychiatric medications. On the MDMA day, people come in, and we test them to make sure they’re not pregnant or taking other substances. We check in with them, and then, usually around 10AM, they take the medication — or the placebo, in terms of the double-blind study. Then we sit with them.
Typically, they wear headphones and blinders, and they go inside — we encourage them to be inside at least 50% of the time. We check blood pressure. At some point, they’re offered a supplemental dose, which is a dose of MDMA in addition to their initial dose, usually about half of the amount.
We sit with them for eight hours, encouraging them to go inside, processing when they’re not, helping them through difficult points and helping integrate the experience. Usually, by around 5PM, they’re feeling ready to make a transition, and we hand them off to a sitter, who spends the night with them in the clinic. They have their privacy in the room — the sitter’s available on the other side to keep them safe overnight. The therapy team comes in the next morning, checks them out for a 90-minute session, and helps them process their experience. If all is well, they go home.
They have three more prep sessions the following month, and then we schedule their next MDMA session.
Can you contrast MDMA’s mechanism of action with SSRIs like Zoloft?
SSRIs are selective serotonin reuptake inhibitors, so they block the reuptake of serotonin in the synapse between the neurons. Serotonin builds up and through, that mechanism has an enhanced effect because it has higher concentrations. It’s done on a daily basis, and people need to take them for weeks before they get any benefit. At that point, it looks like sensitivities in the neurotransmitter receptors alter. It’s not simply increasing the levels of serotonin that makes the difference.
With MDMA, it’s a single-day experience. They get a day, and a month later, they get another day, so there’s no continuing medication effect. During that day, there’s a release of serotonin and norepinephrine, but there’s also a release of oxytocin.
Oxytocin seems to calm the amygdala, and to some degree the autonomic nervous system. It’s the bonding hormone that’s encountered with delivery and human birth. It helps to make the mother loving, receptive, forgiving, calm, and peaceful to deal with a young baby. It’s very evolutionarily useful.
So MDMA releases serotonin — which seems to decrease anxiety in the short run —, norepinephrine — a sense of calm —, and oxytocin — a sense of love, connection, and peacefulness. Those things together seem to account for what happens with MDMA. Perhaps oversimplified a bit, but that’s the gist of it.
At some level, we don’t know — and this is true of all medications. We don’t have definitive proof how SSRIs work, and we don’t have definitive proof how MDMA works. But we know these things are going on, so we have speculation on what’s happening.
SSRIs strike me as a materialist approach — here’s a chemical imbalance, here’s how we can change it — whereas MDMA-assisted psychotherapy seems to get more into the internal experience and the depths of the unconscious.
That’s a good way to see it. I think SSRIs, like most of our current psychiatric medications, are a suppressive therapy. They don’t create a cure. They try to reduce symptoms and help make them manageable. One of the problems with suppressive therapies — like with narcotics — is there’s a tendency to have the dose escalate and have symptoms rebound once the body accommodates to them.
We think of MDMA more as a catalyst, but it’s also an evocative therapy that helps people get in touch with better clarity, better safety, and the depths of their traumatic experiences so they can process them, understand them, accept them, and move past them.
MAPS mentions the importance of allowing the “inner guide” to take over.
This is a big difference from modern psychotherapy. In modern psychotherapy, the model is that the professional is the expert. The person comes to the expert looking for help, and the expert offers his or her opinion and directs them.
In the MDMA model, we have the assumption that people know what they need, and there’s an inner healer. We’re trying to honor that. That’s why we send them inside. It’s our assumption that the most important and profound healing goes on in their own inner world and not through dialogue with us. We help them understand it, help them have some insight into it, but our belief is that their inner healer is really the expert. We’re there as collaborator and support.
It also empowers the individual.
Oh yeah. Our current model, whether it’s medications or the expert in psychotherapy, creates dependency and sometimes a lack of confidence.
MAPS has an optimistic forecast that MDMA-assisted psychotherapy will be legal in 2021.
The FDA looked at the Phase 2 data — the best evidence we have so far — and gave us Breakthrough Status, which means this is far and above a better treatment than we have currently available — better than those three things I mentioned before. We’re very hopeful that our Phase 3 data will be equally powerful and lead the FDA to give us approval. Certainly that’s not given. We have to do the research, which is a lot of work, and you’re never guaranteed in doing research. So it’s a challenge, and it’s a gamble. But we feel pretty confident we’re going to see Phase 2 wasn’t a fluke.
If it gets green-lit in 2021, will the therapy be limited to veterans with PTSD?
No. It will be limited to people with PTSD, from any cause — combat, rape, natural disaster, assault, car accidents, whatever it might be. Phase 2 included a number of veterans, but it included plenty of people who were not veterans. Our goal is to enroll veterans as part of the population, but we want a diverse population. It is in no way limited to veterans.
And will it look similar to how it looks now?
It will likely be given only in a controlled setting, like this one. People will likely never go home with it. The therapy will be done by people who have been through a MAPS-approved training, so they understand how to work with it. You’ll likely have to have another level of licensure as a physician, so the everyday physician won’t be able to write a script for it. And it will probably be limited to centers.
We are also hopeful that the FDA will grant us Expanded Access, also called Compassionate Use. We have over 50,000 people on a national waiting list now, and somewhere around 200 people in the Phase 3 trial. The long and short of that is we’re hardly going to touch the waiting list. That’s why we’ve applied for Compassionate Use. If the FDA grants it, we can take in people who are outside the study and put them through the process. This could be as early as next year. We’re hopeful that the Wholeness Center will be one of the first to be granted that.