Post traumatic stress disorder, or PTSD, can cause flashbacks, panic attacks, angry outbursts and self harm. It’s one of the most common conditions facing Veterans in the United States, and there is currently no simple cure. But some researchers suspect that there IS an effective treatment out there - a drug that’s been illegal in the US since 1985 - MDMA, sometimes known as molly or ecstasy.
Christy and Carolina are part of a team of researchers at Brown University who are running the first study to see how this drug might help veterans with PTSD and Alcohol use disorder.
Why study an illegal substance that’s known as a party drug?
Christy Capone 01:17
I mean my direct answer to that is that people are dying.
Megan Hall 01:20
Christy Capone is a psychologist at the Providence VA. She’s watched her clients struggle with PTSD for years.
Christy Capone 01:28
You know from my own clinical work, I have lost veterans to suicide, and I have met with their grieving families, and you know, it's, it's pretty intense. And so I feel like we need to think outside the box and we need to be open to exploring additional options.
Megan Hall 01:48
She says the current treatments for PTSD just aren’t enough.
Christy Capone 01:51
there are a couple of FDA approved medications to treat PTSD, those are both SSRIs or antidepressants. They don't have a huge amount of efficacy, but that's what we have as far as medication goes. And then we have some evidence based treatment approaches where we’re talking and trying to really work through a particular traumatic event. And those treatments do work well for some people, but there's a really high dropout rate. And especially for Veterans that are more complex or more severe in their symptoms, they tend not to work as well.
Megan Hall 02:27
And many Veterans struggle with not just PTSD, but alcohol use disorder too.
Carolina Haas-Koffler 02:32
There is a lot of research done on which disease you want to treat first. The reality is that they go hand in hand.
Megan Hall 02:41
Carolina is a professor at Brown, She’s an expert in drugs and the effect they have on the body, a field known as pharmacology. She says, drugs designed to help people stop drinking often don’t work on people with PTSD.
Carolina Hass-Koffler 02:55
people suffering from PTSD and tends to drink really to alleviate the symptoms and developing the secondary diagnosis with alcohol use disorder.
Megan Hall 03:05
So one kind of leads to the other.
Carolina Hass-Koffler 03:07
Exactly, exactly.
Megan Hall 03:09
She says people with PTSD are often even excluded from clinical trials on drugs for alcohol use disorder.
Carolina Hass-Koffler 03:15
So we are not covering this very needed population. So creating a study using MDMA, will allow us to really tackle these issues.
Megan Hall 03:26
And what does MDMA do that's different from other drugs out there? Why is it the drug you chose for this research?
Carolina Haass-Koffler 03:33
MDMA is a drug that allow the individual to go through a mental process, an educated process of externalize their intimate trauma experience. So the medication itself allows you to this openness, and creating these access to those memory that are deep in the brain of those individuals,
Megan Hall 04:01
MDMA allows patients to re-experience traumatic events without the same sort of resistance?
Carolina Haass-Koffler 04:12
it's more like that the individual start to developing an empathetic feeling towards to themself, and therefore They are more open to start to live this experience, in protected, safe environment, guided by the clinical psychologist.
Megan Hall 04:33
That part about being guided by a clinical psychologist is important. This research combines MDMA with traditional therapy. The idea is, MDMA might make it easier for clients to work with a therapist.
Christy Capone 04:46
And as Carolina was saying, part of what MDMA does, is increases, you know, feelings of connectedness of trust, you know, of empathy. And it also can reduce some of the fear that these, you know, especially traumatic memories, people are very fearful of them. And so, less fear and more openness is kind of a good state to be in to work through some really difficult things
Megan Hall 05:13
So, walk me through the experience for that veteran…
Christy Capone 05:16
So for this protocol, there are three what we call preparatory sessions where the veteran comes in, they meet with their therapist, there's a pair of therapists for every session. And so the beginning is getting to know the patient, understanding a little bit about their trauma, you know, their background, establishing a foundation, a good relationship with them, and then preparing them for the MDMA experience itself.
Christy Capone 05:45
And then there's the first MDMA session, which - that will last about eight hours long.
Megan Hall 05:49
That's a long time what happens in those eight hours time?
Christy Capone 05:54
Indeed. And so typically, they'll come in the morning and get settled in, and then they'll be invited to take the first dose of MDMA. And so it's a capsule, they'll take that. And then, and then the experience will begin. And the experience can be very inward focused. So we provide them with eye shades and headphones, there's a whole psychedelic playlist on Spotify that’ll be playing. And there's a balance between interacting with the therapists, but also kind of just being inward in their own experience. And you honestly don't need to lead people to the trauma, it just comes up. Like when defenses come down, when someone is a little more relaxed, and they don't have their guard up. You know, that that's what happens.
Christy Capone 06:44
And so, so this will continue for about eight hours until the effects wear off. And then they will go home. Then starts what we call the integration piece, which there are three sessions. The first one starts the next morning. So they're, they're coming right back in the morning to meet with their therapists again. And the point is to sort of integrate the experience, like what came up? What was it like? What, you know, how are they maybe thinking about things a little differently? And how can we sort of keep that going, or what still needs to be addressed? what still needs to be healed, you know, in the second session
Megan Hall 07:21
This process repeats, with another MDMA session followed by three more rounds of therapy. In total, there are 11 sessions of therapy, 2 using MDMA
Christy Capone 07:32
So it's a pretty hefty dose of – of therapy.
Megan Hall 07:36
Christy and Carolina’s study is just beginning, but they’ve seen data from other studies that suggest MDMA assisted therapy can make a huge difference.
Christy Capone 07:45
People just get so much further down the road after this experience than they do, even if they're coming in every week and sitting in my office. And so like some of the veterans that I work with, have deployed three and four times and have had multiple, you know, horrendous experiences. And so it’s a long road of trying to unpack that and walk through it, and people very much avoid talking about these things, because they're so distressing. So if they can, you know, approach it rather than avoid it? It's pretty compelling.
Megan Hall 08:18
But the future of MDMA treatments is still fairly uncertain. In early June, an FDA advisory committee rejected a similar study treating PTSD in veterans, citing potential side effects, and the need for more data.
The committee’s decision isn’t binding, but it could influence the FDA’s final decision about the treatment, coming later this summer.
Megan Hall 08:40
What's your reaction to that decision?
Carolina Haass-Koffler 08:42
I would say that is a tragedy, because like we started talking, here is why we started because there is a clinical need. And so from that perspective, we're going to have individuals that still need to wait probably for a long time before they can receive the full treatment in a clinical setting. For us, as researchers, doesn't change much, because what it means that FDA wants more data, wants more safety data, more efficacy data. And that is the reason why we are doing this work.
Christy Capone 09:13
I agree. And I was disappointed, but not entirely surprised. And I do think this is something different that people, you know, have some fears about or some healthy skepticism. I think skepticism is warranted. But I also think some of my reaction was that there are folks that maybe were on the advisory panel that believe, you know, in the treatments we have, and think why do we need to do this? Why do we need to do something that may have some adverse events? The safety data, frankly, was pretty darn good. It was really good. So, but I think that some people, you know, kind of really balk at the therapy part that it sort of seems kind of woowoo or kind of wishy washy, and they think we already know how to treat PTSD. And frankly, those folks are not sitting in the room with the patients that I am. If they were I think they would think differently, not that they shouldn't be careful and look at the data very seriously. But I think the openness to new approaches, you know, may not be there.
Megan Hall 10:21
Christy and Carolina hope that their study might be able to add more data to prove the effectiveness of MDMA assisted therapy. They’re using patient surveys to measure changes in PTSD symptoms and alcohol use. They’re also adding an extra layer of data – brain imaging.
Carolina Haass-Koffler 10:38
We doing an MRI, pre and post therapy. Why are we doing that? They are important component in the fact this is a completely different approach. We provide a medication we provide therapy, and then the patient doesn't need to continue to take the medication. So there has been something in the brain, where there is a rewiring, there is a different connectivity, there is less inflammation, something happened that we are interested in to see what was going on. We hopefully to provide biomarker that can really make the FDA much more comfortable in ensuring that this change in the brain, it is something that we can also be able to measure.
Megan Hall 11:22
When I spoke to Carolina and Christy in mid-June, their study was just getting started. And that exact day, they reached a big milestone.
Carolina Haass-Koffler 11:31
Today is a great day, right? Tell them
Christy Capone 11:33
Today is an exciting day. So we have started recruiting participants, but we have enrolled our first participant and they are coming today for their first therapy session, not not an MDMA session, that's in a few weeks. But it is really exciting to be at this point, finally.
Megan Hall 11:52
What gives you both your passion for doing this, you have to go through a lot of red tape, and it's a topic that, you know, has some skeptics, what keeps you motivated?
Carolina Haas-Koffler 12:03
For me it’s also personal. I actually served in the military, in Italy. And I was deployed three times, one during the Somalia war, then in Rwanda genocide, and then in ex-Yugoslavia. So I watched firsthand what happened, what are the trauma, and the violence and the cultural difference that we see happening in a war zone. And when I came back, it was hard to come back I have to say and this was building up one tour after the other. So I know what's happening to those individuals.
Megan Hall 12:43
But despite the strain of her deployment, Carolina doesn’t suffer from PTSD or alcohol use disorder. She’s always been curious about why.
Carolina Haass-Koffler 12:53
And so for me having this understanding of what happened to the brain a biological level, and affect the behavior of a person has been critical in everything I've done.
Christy Capone 13:05
I think, you know, like a day like today when this veteran is starting this treatment finally, it just means everything like it means you know, there's this hope that this might be a game changer for some people. And you know, and honestly, in our lab space, we dedicated this space to a veteran who's no longer with us. And that really keeps me going as well like to honor him and to try to do better.
Megan Hall 13:33
Christy and Carolina, thank you so much for joining me today.
Christy Capone 13:36
Thank you for having us.
Carolina Haass-Koffler 13:38
Thank you for having us.