The Western IRB, which approved the MDMA/PTSD protocol on July 10, informed us by letter that approval was withdrawn. The revocation was based on secondhand reports of conversations (not on data!) that …
On July 10, we received word that the Institutional Review Board (IRB) had approved MAPS’ MDMA/PTSD study! We can now definitely say that the US study will take place. Dr. Michael Mithoefer still …
MDMA/PTSD protocol submitted to the Western Institutional Review Board (WIRB). Review expected to take 3-5 weeks.
FDA gives final approval to conduct the treatment sessions in Dr. Michael Mithoefer’s office, with a “crash cart” and an Emergency Room doctor and nurse in the next room in case they …
Conference call with Dr. Mithoefer, Rick Doblin and FDA officials, in which we come to tentative agreement to conduct the study in Dr. Mithoefer’s office, as long as we hire both an ER doctor and …
FDA rejects our request, primarily saying that they would like a larger emergency response team.
Request submitted to FDA to change the location of the treatment sessions from the Medical University of South Carolina (MUSC) to Dr. Mithoefer’s office. We propose renting a “crash cart” …
The fourth patient in the Spain MDMA/PTSD dose-response study was treated on November 28, 2001. We have now completed the 50 mgs dose group (3 patients received 50 mgs and 1 received a placebo). The next …
It’s my pleasure to report some excellent news. About 10 AM, Friday, November 2, FDA contacted me to say that MAPS’ MDMA/PTSD protocol was approved. This approval marks the culmination of 16 …
MAPS submitted to the FDA today the protocol for Dr. Michael Mithoefer and Dr. Mark Wagner’s MAPS-supported pilot study into the use of MDMA-assisted psychotherapy in the treatment of patients who …
As part of its submission to FDA of a protocol designed to study the use of MDMA in the treatment of PTSD, MAPS’ commissioned an extensive review of the scientific literature on MDMA. This literature …
A draft of the MDMA/PTSD protocol that MAPS has been working for 2 years to develop, with Dr. Michael Mithoefer and Mark Wagner, Ph.D., at the Medical University of South Carolina, has now been posted …
