Summer 2004 Vol. 14, No. 1 10 Stamps and $250,000
Shortly after MAPS’ U.S. MDMA/PTSD study was fully approved and underway, I scheduled several meetings with Israeli Ministry of Health officials to work on starting in earnest the protocol design and approval process for MAPS’ proposed Israeli MDMA/ PTSD pilot study, for which MAPS has budgeted $75,000. On April 30, 2004, I met with Israeli psychiatrist Dr. Moshe Kotler, the Principal Investigator of MAPS’ proposed study which will include subjects with war- and terrorism-related PTSD (subjects with war-related PTSD are excluded from the U.S. MDMA/PTSD study). Dr. Kotler has previously been the chief psychiatrist for the Israeli Defense Forces (IDF). Dr. Kotler indicated a strong interest in seeing the study conducted and suggested we use a dose-escalation design. He stressed the need for patience and outlined a timetable that will hopefully result in the study being reviewed and approved by an IRB (called Helsinki Committees in Israel) by fall 2004. Review and approval by the Ministry of Health would occur sometime after that.
On May 2, 2004, I met in Jerusalem with Ministry of Health official Dr. Miki Reiter, who also expressed support for the study. We discussed practical issues such as obtaining an Israeli translation of our primary outcome measure, the Clinician Administered PTSD Scale (CAPS).
It has been a long process since I submitted my DEA application in early July 2002, but persistence finally paid off. Why it took so long for the DEA to process my application is not a trivial question. Whether from inefficiency or motivated by some agenda, inappropriate bureaucratic delay of legitimate research constitutes a serious interference with scientific inquiry. And this inquiry is, after all, directed at potentially relieving human suffering. In a free society, we should ideally be able to get an answer to this question. We may never have that answer; however, the regulatory system did work in the end, and for that I am grateful.
We have sent out letters to psychiatrists, psychologists, and other therapists in the area asking them to refer patients whom they think may qualify for the study. We have also had several inquiries from people who live in other areas and are willing to travel to Charleston to participate. We are finally under way!
While in Jerusalem, I also had the very moving experience of meeting with an Israeli dentist who contacted MAPS in April 2004 after he conducted an Internet search on MDMA and PTSD. He had PTSD as a result of a suicide bombing in a cafe in March 2002 that killed eleven people. He has permanent hearing damage but no other serious persisting physical injuries.
After the bombing, he had been treated for PTSD with psychotherapy and SSRI drugs with limited benefits. He subsequently used Ecstasy (MDMA) in a recreational setting and found that it helped reduce his PTSD symptoms. He spoke to his therapists about this and they had never heard of MDMA being used to treat PTSD.
I found him to be sincere and emotionally open. He was able to laugh at times and talk clearly about what happened and about the consequences in terms of nightmares, hyperarousal, and other symptoms. When we were getting ready to leave our meeting place, he asked if I had realized that it was the same cafe in which the explosion took place. I hadn’t and immediately saw the entire conversation in a more vivid light. On a walk to his office a few blocks away, he pointed out where a more recent explosion had taken place in a bus, killing several people. He heard the explosion, rushed out and was among the first on the scene. Due to his medical training, he decided to go inside the bus. He carried people out and, until the rescue squad arrived, helped provide medical care to some of the people still alive inside. He was initially retraumatized but shortly afterwards felt that helping others and being in control of his actions, as con- trasted to his loss of control over his personal safety when he was in the cafe explosion, was an important part of his healing process.
I returned home from Israel with renewed hope for the eventual approval of MAPS’ Israeli MDMA/PTSD pilot study. I felt a greater sense of the contribution that this research can make toward developing new methods to heal the terrible trauma of war- and terrorism-related PTSD suffered by people on all sides of numerous violent conflicts around the world.