| 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.
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 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 expected
to start by April 2006. MAPS is also working to co-sponsor, with
the Swiss Association for Psycholytic Therapy, an
MDMA/PTSD pilot study in Switzerland.This study has been approved
by the ethics committee and is currently under review by Swissmedic
(Swiss FDA).
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 funded a study of MDMA-assisted
psychotherapy in subjects with anxiety associated with advanced-stage
cancer, but it is now funded by Peter Lewis and is now sponsored by investigator John Halpern MD. This study will start in early 2006, after final DEA
approval has been obtained.
Donations
to support MDMA psychotherapy research are needed. Donations
can be restricted to any specific study or to our MDMA research
in general. |
