The Lahey Clinic Institutional Review Board (IRB) met this evening to review the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer, to be directed by co-investigators Dr. John Halpern, Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel. This protocol has to be reviewed and approved by both the IRB at McLean, where the psychotherapy and experimental sessions will take place, and by the IRB at Lahey Clinic, where Dr. Shuster works and from where the subjects will be recruited.
After the protocol was introduced by Dr. Shuster, Rick Doblin, Ph.D. and Dr. Halpern responded for about 30 minutes to a series of thoughtful and important questions from members of the IRB. The protocol and second, short informed consent form (covering just the initial screening process at Lahey) were then…approved! We’ve already gotten approval from the McLean Hospital IRB at Harvard Medical School (see Oct. 27, 2004 entry), so now it’s on to the FDA. We expect to submit the documents to FDA within the next week to ten days. FDA must, by regulation, respond in some manner within 30 days.