Virginia Wright (Interview Archive)
We've got a trial running in Boulder that takes on PTSD regardless of where it came from. Our standard approach pairs a male and a female therapist, which gives the patient someone to connect with whether they respond better to a man or a woman. For this one, though, we're matching a seasoned therapist with an intern to find out whether that combination holds up just as well. Beyond Boulder, there are smaller studies in Israel, where war trauma gives them plenty of cases to treat, and another one underway in Vancouver.
All of these wrap up this year. Once they do, we pull the phase two data together, write it up, and bring it to the FDA for sign-off. We expect approval, which moves us into phase three and work with several hundred subjects. If the timing holds, that should be finished by 2021, and at that point MDMA becomes available by prescription. To be precise, it isn't MDMA on its own; it's MDMA-assisted psychotherapy prescribed as a treatment for post-traumatic stress disorder.
The therapy part is worth dwelling on, because it runs against how most drugs get prescribed. Among people doing this work, there's broad agreement that you don't take these substances alone. You want a therapist present, or a shaman if the experience involves ayahuasca or ibogaine, simply because the compounds are so potent. There's a solid research base behind using them safely and to real benefit, so it makes sense to build that guided experience into what we and others are now doing.
We also have two smaller projects going. One is MDMA-assisted psychotherapy for adults on the autism spectrum, and we just published a paper on it with encouraging results. The aim there is anxiety, and what we keep seeing is that MDMA-assisted psychotherapy reaches trauma, anxiety, and depression, that whole cluster of conditions.
Running alongside that is a study on MDMA-assisted psychotherapy for the fear of death in people facing life-threatening illness, based in Marin. It kicked off just last week, so it's barely started.
Then there are four parallel studies using MDMA with people inside the Veterans Administration and the Department of Defense, done in partnership with them. The question is whether MDMA can support the therapies already in use. These four aren't formally part of the phase two drug development plan. They sit beside it, helping us learn more about post-traumatic stress disorder while helping the people who treat PTSD learn more about MDMA and psychedelic psychotherapy. A good working relationship has grown out of that. It began modestly, but we've managed to do some real good in building those ties.