Rick Doblin speaks with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin apologized for the tone of the WIRB letter and seemed to view favorably MAPS’ arguments. He was informed …
Dr. George Ricaurte publishes an article in Science reporting on primate data that he claims suggests that even one night’s recreational use of Ecstasy can lead to Parkinson’s. This government-funded …
John Mendelson, M.D., Associate Professor at University California San Francisco, commented on Michael Mithoefer, M.D.s proposed MDMA study. Mendelson states that the risk of heart valve changes after …
The Western IRB, which approved the MDMA/PTSD protocol on July 10, informed us by letter that approval was withdrawn.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 …