| Dr. Mithoefer's MDMA/PTSD protocol was initially
approved by FDA on November 2, 2001. This is the first ever FDA-approved
protocol designed to investigate any therapeutic potential of MDMA.
A revised protocol, which shifted the location of the study, was approved
by FDA on June 14, 2002. The protocol was approved by an Institutional
Review Board (IRB) on September 23, 2003. The DEA inspected the research
facility on October 28, 2003 as part of its review of Dr. Mithoefer's
application for a Schedule I license, and on Dec. 11, 2003, we learned
that the South Carolina DEA recommended to DEA headquarters that Dr.
Mithoefer receive his Schedule I license. On February 23, 2004, DEA
issued Dr. Mithoefer his Schedule I license and the study was fully
approved to begin.
Here is the current version of Dr. Michael Mithoefer's MDMA/PTSD study protocol (PDF) and informed consent forms for the study, (PDF) and for Stage 2 (PDF).
For a discussion of the therapeutic approach used in the study, we've created a treatment manual describing MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder in PDF or HTML formats.
MAPS has been working since it was founded in 1986 to initiate
research into the therapeutic use of MDMA. The final approval of
Dr. Mithoefer's MDMA/PTSD protocol marks the culmination of almost
eighteen years of struggle. Approval is also a beginning of what
we hope is a 5
year, $5 million plan to develop MDMA into a prescription medicine
for the treatment of PTSD.
MAPS is also co-sponsoring, with the Swiss Medical Association for Psycholytic Therapy (SAePT), an MDMA/PTSD pilot study in Switzerland. This study began enrolling subjects in late 2006. MAPS has also obtained final approval for a study in Israel into the use of MDMA-assisted psychotherapy in subjects with war and terrorism-related PTSD with the study to begin enrolling subjects in early 2007.
MAPS was supporting a pilot
dose-response study in Spain into the use of MDMA-assisted psychotherapy
in the treatment of PTSD, but that study was halted due to political
pressure from the Spanish Anti-Drug Authority. MAPS is working to
obtain permission to restart that study.
MAPS coordinated the design, approval and funding of a study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer, to take place at McLean Hospital, Harvard Medical School. The study is being sponsored directly by Peter Lewis and began seeking to enroll subjects in January 2007.
Donations
to support MDMA psychotherapy research are needed. Donations
can be restricted to any specific study or to our MDMA research
in general. |
