Summary: WikiTribune features a Q&A with MAPS Public Benefit Corporation Clinical Data Scientist Allison Feduccia, Ph.D., to discuss the U.S. Food and Drug Administration (FDA) granging Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD).
WikiTribune: What does getting breakthrough therapy designation mean?
Alli Feduccia: You have to show that you’re treating a life-threatening illness, which PTSD is. You also have to show that your drug is more effective in the Phase II trials compared to currently available treatments. We were getting a larger number of people not meeting PTSD criteria after the Phase II trials. Then we were also able to show that MDMA in this context was safer than these two SSRIs (Paroxetine and Sertraline – antidepressant medications) because their side effects can be significant for patients who take them daily. With MDMA we don’t see these adverse events.
Originally appearing here.
MDMA, a highly illegal drug commonly associated with raves, could by 2021 become an approved medication in the United States in the fight against one of the world’s most common and debilitating mental health conditions – post traumatic stress disorder (PTSD).
PTSD (NHS) is an anxiety disorder that affects millions of people worldwide. An estimated 24.4 million Americans suffer from some form of PTSD at any given time, according to PTSD United, a non-profit support group. Women are twice as likely to develop it, with one in nine women suffering from PTSD in the U.S.
In the UK, an estimated three out of every hundred people suffer from the condition, according to Patient, an independent provider of health services.
The condition, whose symptoms can vary enormously, can be treated with antidepressants and psychotherapy (NHS). But these treatments are not always effective, and in some cases must be continued for years on end.
The Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research organization based in the U.S., recently completed the intermediate stage of clinical trials to see whether MDMA-assisted psychotherapy could prove more beneficial for people suffering living with PTSD – with promising results. They have raised almost $27 million in private donations to fund the last leg of clinical trials needed before the U.S.’s Food and Drug Administration decides whether to give MDMA the green light as a medication for PTSD.
As part of our “war on drugs” project, WikiTribune spoke with Alli (Allison) Feduccia, a clinical data scientist at MAPS who has been helping lead the clinical trials, to better understand just how close patients might be to a potentially new and more effective way of treating PTSD.
This interview has been condensed and edited for length and clarity.
WikiTribune: Can you tell us a bit about how MDMA-assisted psychotherapy came about?
Alli Feduccia: MDMA (3,4-Methylenedioxymethamphetamine) was first discovered in 1912 by Merck Pharmaceutical company in Germany. They didn’t really ever discover the psychoactive effects at the time. Then it was re-synthesized in the 1970s by Sasha Shulgin – a chemist in the Bay Area – who was creating a number of different psychoactive substances. He and his wife, who was a therapist, took MDMA and shared it with some of their psychologist friends because they thought it could be of good use if combined with therapy.
WikiTribune: Was this legal?
Alli Feduccia: It wasn’t ever going through regulated control and clinical trials. Then it got really popular and spread into the mainstream. With that the Drug Enforcement Agency (DEA) cracked down pretty hard. It was at the same time as the “war on drugs” during the Reagan administration. It was placed as a Schedule I substance in 1985.
WikiTribune: Tell us a bit about MAPS.
Alli Feduccia: Rick Doblin founded MAPS in 1986. The main goal of that was to take MDMA through the research trials to have it become an FDA-approved medication. It took a long time to actually start any trials. They had to do studies in animals – Phase I trials – to show it wasn’t toxic. All the money was raised from private donations, which was a really hard thing to do especially in the 1980s and 1990s because there was such stigma around using substances. It wasn’t really understood how it could be applied in medical context.
WikiTribune: What changed?
Alli Feduccia: It’s really probably just within the past three years that the culture has really shifted its perspective on using MDMA in the context of therapy. That’s largely from the small trials that were published that were testing MDMA in assisted psychotherapy for treating PTSD and the media coverage around that.
WikiTribune: Can you pinpoint a watershed moment?
Alli Feduccia: The first trial with PTSD and MDMA was published in 2011. That really just put it back on the map for a lot of people. But there were limitations to the study. Now it’s been repeated in six Phase II studies, and MAPS in 2016 presented all this data to the Food and Drug Administration (FDA). Shortly after that the FDA granted breakthrough therapy designation for this treatment.
WikiTribune: What does getting breakthrough therapy designation mean?
Alli Feduccia: You have to show that you’re treating a life-threatening illness, which PTSD is. You also have to show that your drug is more effective in the Phase II trials compared to currently available treatments. We were getting a larger number of people not meeting PTSD criteria after the Phase II trials. Then we were also able to show that MDMA in this context was safer than these two SSRIs (Paroxetineand Sertraline – antidepressant medications) because their side effects can be significant for patients who take them daily. With MDMA we don’t see these adverse events.
WikiTribune: You sound pretty hopeful about the upcoming Phase III trials.
Alli Feduccia: We are if we can replicate what was done in Phase II. We’re hopeful that we’ll be able to get approval for MDMA in the United States by 2021.
WikiTribune: What are the main challenges MAPS faced when conducting this research and then the trials related to MDMA and PTSD?
Alli Feduccia: I think the challenges have changed over the years. Getting approval from the FDA and DEA to perform studies with Schedule I drugs was one. Another has been raising money to support these trials. Not very many non-profits are able to do drug development because the costs are so high.
WikiTribune: There hasn’t been any public funding for this research?
Alli Feduccia: It’s all been private. There are some small family foundations that have given money. The strategy has been largely reaching out to the psychedelic community and people that have probably some understanding of these substances.
WikiTribune: It seems almost as if there’s been quite an under-reported grassroots movement to see this through. Is that fair to say?
Alli Feduccia: For sure. All over the world. More people than just the psychedelic communities are looking toward this. There’s not a lot of great treatments for mental health conditions and people are really searching for anything that can help. There’s now a lot of shifts in the scientific communities. M
uch of it is to do with ketamine therapy for treating depression and medicinal cannabis. They may be opening people’s mind to the idea that some of these drugs that have been demonized may actually have therapeutic value.
WikiTribune: How does MDMA-assisted psychotherapy for PTSD treatment work?
Alli Feduccia: The treatment we use is always a male and female therapy team. The person first has three non-drug sessions and the MDMA sessions are spaced a month apart. We usually give three doses of MDMA. Then during that month in-between they get three, we call it, integrative sessions that are also non-drug and last about 90 minutes. MDMA can reduce fear and pain around emotional injuries and traumatic experiences so patients are really able to talk about and reprocess events and situations that under a normal state of consciousness could be too painful to emotionally engage with.
But there’s a lot of psychological things happening as well beyond just the physiological effects of MDMA. A lot of psychotherapy, a lot of support. The MDMA is thought to catalyze the therapeutic experiences that are happening.
WikiTribune: What are the results so far?
Alli Feduccia: The effects are durable for most people 12 months later. Even the beneficial effects continue to grow for a number of people. Patients’ relationships get better so they can go back to work or other avenues in their life that were really impacted by severe symptoms of PTSD. They’re able to reintegrate fully into life.
WikiTribune: Why haven’t PTSD treatments developed much over the past decades?
Alli Feduccia: I think it’s hard to just target symptoms and not ever come to a resolution around the traumatic memories. That may be why some of the non-drug (SSRIs) based therapies are more effective.
WikiTribune: What has been MAPS experience working with the FDA with regards to MDMA?
Alli Feduccia: The FDA has been evaluating these drugs in the same way that they do any other pharmaceutical drug. There hasn’t been any hurdles placed in our way from the FDA. They’ve been really great to work with. I think that really shows that they are evaluating these drugs in an unbiased way and putting a clear statement out to the public that they will try to speed up the discovery and the development of these substances if they’re shown to be safe.
WikiTribune: If MDMA gets the green light from the FDA for a treatment for PTSD treatment what’s next for you?
Alli Feduccia: We’ll continue to go to other countries to do the necessary studies to gain approval around the world. Another big thing is training therapists that will be qualified to deliver MDMA-assisted psychotherapy. We’re really thinking about scaling up our therapy training program to meet that need. We’re interested in other compounds too. Cannabis, ayahuasca, ibogaine – any of the other drugs that have shown promise in initial trials and case reports.
WikiTribune: How likely do you think it is that you might be able to get public funding for any of these?
Alli Feduccia: I think it’s becoming increasingly more likely in the next few years. I was just at the American Society for Clinical Psychopharmacology Conference in Miami, Florida. They had a panel with representatives from NIAAA, NIDA, NIMH, the EMA and the Department of Defense (DOD). All except for the DOD said that their agencies would fund the therapeutic use of psychedelics. While they haven’t put out an official funding announcement, I feel the supporting data and scientific evidence, as well as public demand for more research into these substances, is growing.