Therapist Training Protocol Leads to Positive Teleconference with FDA

Summer 2009 Vol. 19, No. 2 Research Edition

Download this article.

On June 22, 2009, MAPS submitted a protocol to FDA requesting permission to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS’ MDMA/PTSD research. On July 23, Rick Doblin, PhD, Michael Mithoefer, MD, and MAPS Clinical Program Manager Amy Emerson had a productive and positive teleconference with six members of FDA’s Division of Psychiatry Products. The FDA officials made a series of suggestions about how, from their perspective, we could improve the protocol. They suggested that we write the protocol so that it would more closely resemble a Phase 1 safety study in normal (healthy) volunteers. The revised protocol will include more measures of the psychological effects of MDMA on healthy participants. We plan to submit the revised protocol in mid-August and should learn by mid-September if it’s approved.

We learned that we could provide much in the way of educational experiences during our recent therapist training seminar that took place in Austria, with therapists from seven different countries. Nevertheless, we also believe it will benefit therapists who will be administering MDMA to patients to achieve a personal or subjective understanding of MDMA’s effects when administered within a therapeutic setting. The only way such an MDMA experience can be legally provided to therapists is through an FDA protocol designed to gather safety information on the effects of MDMA. The protocol requires potential participants to have first successfully completed a nondrug therapist training program where they will watch video tapes and review our treatment manual. We believe this protocol will significantly enhance our ability to train therapists to work more effectively on our MDMA/PTSD studies.

While many people may doubt the feasibility of asking the FDA to approve the administration of a Schedule 1 drug to therapists in order to better understand the effects of that drug, we have thus far been greatly encouraged by FDA’s suggestions and handling of this project. The FDA has so far shown us that developing MDMA into a prescription medicine is a matter of science, not of politics. As long as we continue to operate with the highest standards of research and data collection and to follow the guidelines set forth by the FDA and the European Medicines Agency (EMEA), it will be the results of the research (and not ideology) that determines whether or not MDMA is approved as a prescription medicine.