The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating
MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic
posttraumatic stress disorder (
PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the
therapeutic use of
MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for
Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on
MDMA, and also on
PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of
MDMA-assisted psychotherapy for
PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have
Zoloft approved by the FDA for use with
PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of
Zoloft for
PTSD.