December 27, 2012
Rick Doblin Responds to The Guardian
By: Rick Doblin
MAPS Executive Director Rick Doblin offers his input in response to an article featured on The Guardian. While touching upon the author’s and commenters’ points, Rick provides clarification about our MDMA-assisted psychotherapy research.
Originally appearing here.
I’m the Executive Director of MAPS (http://www.maps.org), the non-profit organization that sponsored the MDMA/PTSD research. We’re working with a team in England led by Dr. David Nutt that is seeking to obtain funding to conduct an MDMA/PTSD study in England, with MAPS training their therapists. We should know by the end of summer whether this study will be funded and approved, with funding applied for to a traditional research funding body.
“hollyelis”, who posted a comment, is a female and wondered if the results applied to her, since she said the initial study was conducted in 20 men. Actually, the initial study of 20 subjects included 17 women and 3 men, so the results to apply to women with chronic, treatment-resistant PTSD from childhood sexual abuse, or adult rape and assault. Our current US study is in 24 veterans and firefighters and we’ve enrolled 11 subjects so far. We’re investigating whether war-related PTSD can be treated the same way as trauma from childhood sexual abuse, or adult rape and assault, and whether MDMA will work as well in men as is does in women. So far, it looks like PTSD from war-related trauma can be treated the same as PTSD from sexual abuse, rape and assault, and that men respond as well as women. We’re trying to enroll half men and half women, but that isn’t likely to occur, most subjects will be male. Furthermore, all the women enrolled have been veterans with trauma related to being raped by male US soldiers.
Hollyelis also questioned how “such a small sample can produce much significant scientific data.” Actually, 20 subjects is not so small for an initial pilot study. Our results were statistically significant in terms of efficacy and we demonstrated safety under our experimental conditions.This was the first scientific study ever completed about the therapeutic use of MDMA, an earlier MDMA/PTSD study that MAPS sponsored from 2000-2002 in Spain was shut down for political reasons by the Madrid Anti-Drug Authority, after positive publicity about the study. Still, 20 subjects is not enough to prove safety and efficacy to the satisfaction of the FDA. That will required two large-scale Phase 3 studies, each with about 200-300 subjects. We conducting an international series of other small Phase 2 studies to try to gather enough information to guide the design of Phase 3 studies we hope to start in about 3 years.
Then the Phase 3 studies will take about 5 years or so.
One point about the Guardian article is that it suggested the positive results in our initial study could have been do to “regression to the mean” since subjects had high levels of PTSD. While that’s an important point to consider, it’s not likely since subjects in our study had PTSD for an average of over 19 years and had failed on previous psychotherapy and also on previous pharmacotherapy. These were subjects with chronic, treatment-resistant PTSD who were not likely to suddenly get better on their own after an average duration of PTSD of 19 years.
Furthermore, over 700 people have taken pure MDMA in clinical research studies conducted over the last 20 years, mostly looking at safety and mechanism of action. Only MAPS’ studies are looking at using MDMA therapeutically. Temperature increases and dehydration have not been a problem in any of these 700 people. There have been no drug-related Serious Adverse Events (SAEs) in clinical research.
MDMA was invented in 1912 by Merck in Germany and is off-patent. The pharmaceutical industry is not interested in funding research with drugs that can’t be monopolized. That’s why MAPS is currently the only organization in the world funding research into the therapeutic use of MDMA. We hope that David Nutt’s team obtains funding for a study in England.
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