A new study authorized by the FDA focusing on subjects suffering from severe anxiety stemming from a life-threatening condition aims to find out.
Late last week, the San Francisco Chronicle reported that a psychiatric therapist in Marin County, California, has begun recruiting subjects for a study on the possible value of MDMA as a clinical anxiety reducer. The study, led by Dr. Philip Wolfson, received DEA approval this March and has been authorized by the FDA. Dr. Wolfson is seeking 18 adult subjects suffering from severe anxiety stemming from a life-threatening condition with a life expectancy of at least nine months. Once these individuals are selected, 13 will undergo therapy sessions after taking a controlled dose of MDMA, while five will receive a placebo.
Classified as a Schedule 1 drug since 1985, critics of MDMA have linked it to hundreds of deaths in the rave and club scenes. Its effect on users' heart rates and blood pressures has led to fears that it might be dangerous for those with cardiac problems. And university studies have linked it (especially its long-term usage) to changes in neurological functionality, leading to anxiety, depression, insomnia, or paranoia over the long-term (and listlessness and deep sadness in immediate post-use crashes).
Yet in recent years we've come to understand that many early critical studies of MDMA didn't account for subjects' other drug use habits. (Some research on its potential to damage the brain has even been redacted.) We also know that much of the danger of (ostensibly) MDMA-based drugs like ecstasy or molly derives mostly from the questionable additives laced into them. More recent studies, in which over 1,133 people have taken controlled doses of MDMA with no adverse effects, have found that the drug can help those struggling with mental illnesses and perhaps even Parkinson's disease .
Such revelations have led to a renewed interest in research on the psychological benefits of MDMA-based therapies, promoted and funded by organizations like the Multidisciplinary Association for Psychedelic Studies. Since the early 2000s, they and other researchers have performed a number of studies on the effects of MDMA in reducing anxiety in PTSD sufferers and autistic adults who feel stress over their difficulties navigating social norms.
To understand more about the potential of MDMA revealed in these studies, the contributions to be made by the new project in Marin County, and the future of the drug as a psychological aid, VICE reached out to Dr. Wolfson to talk neuroscience, warm therapy, and MDMA legalization.
VICE: We know that MDMA creates a sense of openness and closeness that can help patients to open up and sift through their emotions, but how does that work? And why does MDMA have such long-lasting effects on the way people who take it think and feel?
Dr. Wolfson: It apparently has an effect of making the amygdala [part of the brain's emotional control center] less active. That may contribute to the actuality that MDMA makes it possible for people to tolerate trauma, negative thoughts, more easily—to process them while under its influence and probably thereafter, and to get in touch with positive feelings more easily as the negatives go away.
The afterglow—I don't think anyone has a clear sense of what that is. It's a complex brain-personal-environmental kind of phenomena in which people continue to feel good after having that experience. That's a common thing in [the] mind. Human beings continue to feel great after an uplifting or peak experience [and] that is sustained. Not forever. But we know of that occurring with all kinds of things—with great sex... religious or spiritual experiences.
Some users say their shift in consciousness lasts for months or longer, which seems more significant than the impact of good sex.
I don't know that it's terribly different. I think that a great relationship changes people for life even if it's not sustained. So I don't want to discriminate a drug effect from a human effect.
But there are people who, even with one experience, have sustained emotional improvement for very long periods of time, and I think that's because people are moved psychologically. People emerge from depression or negativity or bad feelings about themselves and others and experience an openness that they haven't had before.
In the autism studies we have just concluded, people who have not had much emotional life because they're high-functioning autistics had a taste of something new for them: a sense of feeling. And that sense of feeling for such people will persist on and on. They've had a knowledge of something else. And I think people can be altered in a very positive direction permanently despite the vagaries of life that may emerge.
Proponents of MDMA-based therapy say that proper guidance and context while taking the drug is important. What guidance will you be providing in your study?
The MDMA experiences are embedded in a complex and intensive psychotherapy process. We, as in all of these studies, have a co-therapy team.
We begin with a very intensive screening process in which we get to know people and what they're about: their illnesses, what their fears and what their social support are like. And then we go through preparatory sessions—all sorts of measures to look at changes during the course of the treatment.
Then we do a 24-hour overnight session, the first one [with MDMA or placebos]. The overnight takes place in a wonderful setting in the study site, which is comfortable, warm, and conducive to openness and to feeling relaxed. It's like building a nest, which is a good thing to do in psychotherapy. People come, stay overnight, are driven home by their support partner the next day after an integrated session. There are three integrated sessions before the next MDMA or placebo session, and that is the pattern.
It concludes after three full MDMA sessions or two full placebo sessions and then three MDMA sessions for the placebo group. Everyone gets three MDMA sessions with intense psychotherapy.
We do many kinds of techniques to help people open to themselves. We're working basically with people's fears of recurrence, relapse, and death itself.
You're looking for subjects without cardiac conditions. Is that because there is a real danger for people with heart problems? And if so, what alternatives are there for them to get a similar experience to MDMA without the amphetamine-related heart issues?
The [cardiac] concern with MDMA is two-fold. The first is that we don't want to have incidents within the study that mar the study. People with hypertension, controlled or not, have a higher risk of having a myocardial infarction. We're trying to keep the study free of events that will pollute it for no good reason. The second is that many of these substances cause a transient increase in blood pressure, which MDMA does (and so does ketamine), so there's a small risk factor for people who have high blood pressure. But in general if MDMA were legal you'd go case-by-case.
Unfortunately the only thing available of a transcendent nature different [from MDMA] is ketamine.
How similar is what your doing to previous research on MDMA's anti-anxiety role in PTSD and autism and how much of what you're doing is new?
The methodology for the actual use of the substance is now standardized with our study. This will be the basis for going ahead: A single dose of 125 milligrams and a half-dose of 62.5 milligrams versus an inactive placebo, that's going to be the model.
And our patient population is totally different in terms of their concerns. There's a PTSD aspect that we're looking at because people with life-threatening illnesses [who] have been treated intensively can have phenomenon very much like PTSD. But we're much more concerned about people's longevity, what they're doing with their lives, how they're impacted directly with their fearfulness, depression, ways in which they're coping. And we're trying to help them look at that much more clearly so they can think about ways that they can make better choices and feel better about the time they have ahead.
Why did you decide to pursue that goal via MDMA versus any other drug or approach?
I worked with MDMA in the legal period with therapies with couples who were significantly depressed, anxious, etc.
In my own particular case, I had a son in that period, my oldest child, who became ill with leukemia at twelve-and-a-half, and during his four years of illness MDMA was part of my life and my family's life. (The kids didn't use it. I have two sons.) And it helped us to process as much as we could and handle terrible circumstances. So personally I knew its power. My son, Noah, died when he was near 17 and MDMA certainly didn't stop the terror or the misery, but it helped us to cope with what was going on and to have a nest in which we could find love and a connection and go on with our lives as well as possible. So I had that personal draw to it and after that I continued to work a lot with people who had life-threatening illnesses in a variety of settings. I knew its power as an empathogen, that is to create a feeling of empathy toward others and toward one's self, to be able to put one's self in other's shoes.
It's unique in that it's not a hallucinogen like psilocybin, which is being used in other life-threatening illness studies at [Johns] Hopkins and NYU. [It's] not a peak-experience psychedelic, but rather something that could be used more in a psychotherapeutic way.
MAPS is hoping to have MDMA legalized and in prescription use within five to ten years. How realistic do you think that is?
I think we have a real shot. I've been out in the open doing this now for a week and the deluge of people who are not experienced in this realm [but] are interested, open to it, is phenomenal. Probably 100 requests [to be a part of the study] from diverse people—a lot with PTSD who don't understand what we're doing.
The process of getting this legalized is fairly straightforward. There could be political pitfalls, but we're finishing up our FDA approach for phase three studies, which are the next phase for approval of a prescription drug, of a prescription method. We hope we can get going with much larger studies. Phase three requires several hundred people.
We'll take two-to-three years before we get approval, so we're hoping, can conceive of, getting formal approval around 2020 if all goes well.
We can also hope for compassionate use because the Veteran's Administration and the whole approach to vets who are struggling with coming back into our society, who are highly suicidal at times—the lack of success of methods at the VA have promulgated an interest in our substance. So we hope that there may be a compassionate use fast-track for some people to avail themselves of the benefits of this as a psycho-therapeutic tool, not just as dropping a drug.
You say there've been positive reactions to your work, but have you faced any backlash?
Not yet. It's always possible. I think there's still some strong feeling about the rave movement and people getting in trouble in the rave movement. There were deaths, and still are, but very rare from MDMA use. And we don't have the answers to all of that, so I can imagine that there are people who are pretty negative with moving ahead with MDMA. But we haven't [seen] it. We're doing a very controlled, thoughtful study. So, so far so good.