Approves MDMA-Assisted Psychotherapy Protocol
Rick Doblin, director of the Multi-disciplinary
Association for Psychedelic Studies (MAPS).
10 AM this morning, Friday, November 2, FDA contacted me to say that MAPS'
MDMA/PTSD protocol was approved. This approval marks the culmination of 16
years of efforts to obtain permission from FDA for MDMA-assisted
psychotherapy research, since MDMA was criminalized in 1985. This approval
also marks the beginning of what I hope will be a $5 million, 5-year
project to develop MDMA into a prescription medicine.
On Wednesday, Dr. Michael Mithoefer, the principal investigator, and I had
a conference call with FDA during which we discussed various design
conference call was calm, serious and respectful. We agreed to make
design changes, mainly closer monitoring of blood pressure and omitting
the opportunity for placebo subjects who still met inclusion criteria for
PTSD at the final evaluation to enroll in an open label extension study
during which they would receive MDMA. We argued against several other
possible changes, mainly the idea that patients should be required to have
had prior experience with McMahon Thursday, I faxed an addendum specifying
the changes we had agreed upon and the places where the protocol needed to
be changed. Last night, I saw on CNN that anthrax was discovered in the
FDA mailroom at Rockville, where the FDA officials reviewing the protocol
work. Today, FDA officials were still at work and informed me that the
protocol was approved without the need for any additional changes.
Of course, we still need to obtain Institutional Review Board approval
from the Medical University of South Carolina. This should take several
I've already let the Israeli Ministry of Health know that the FDA approved
the study. According to Dr. Moshe Kotler, the principal investigator of
the proposed Israeli MDMA/PTSD protocol, FDA approval was need for an
MDMA/PTSD study before he would feel comfortable submitting a protocol to
subjects in the ongoing Spain MDMA/PTSD study are women survivors of
sexual assault with chronic PTSD. The subjects in the FDA-approved study
women and men survivors of criminal assault with chronic PTSD. The Israeli
study will hopefully include subjects whose PTSD was the result of war and
MAPS is now embarking on a $250,000 fund-raising campaign. This amount
should fully fund the US MDMA/PTSD study, the Israeli pilot MDMA/PTSD
study, and the remaining expenses in the Spain dose-response MDMA/PTSD
study. I call this the $5 million, 5 year, 5% campaign (5% of $5 million
A reporter for the Wall Street Journal contacted Michael this morning and
informed that the FDA had approved the study. A reporter for a Boulder
called me this morning and was similarly informed. I'm letting Oprah's
know just in case they want to balance their horrendous show on Ecstasy
Sept. 28 with some factual information about MDMA-assisted psychotherapy.
The formal approval letter from FDA will arrive next week. I'll post the
revised protocol on the MAPS website
sometime next week.
Now, time to celebrate!
Rick Doblin, MAPS
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