Progress to-date is bringing us closer to realizing active clinical research with MDMA, psilocybin and LSD to be sponsored by MAPS. If all continues according to plan, 2004 will bring us to that exciting turning-point, and I very much look forward to offering MAPS members a more detailed report in the ensuing months.
MAPS support has enabled us to draft and complete a protocol for exploring whether MDMA is clinically beneficial to subjects with advanced cancer who are suffering from anxiety associated with their diagnosis. As currently designed, eight subjects will receive MDMA-assisted psycho- therapy and four will receive placebo. Final revisions to this first pilot Phase II protocol are currently being made; we hope to have submitted the protocol for its first IRB review by June. Our ambition is to expand this research work beyond the initially proposed small-N pilot study, but first we need to refine our therapeutic approach, determine appropriate dosing, and gather preliminary information about the safety and efficacy of our treatment in advanced cancer patients.
Our other exciting news to report is the addition of a post-doc fellow in our laboratory: Dr. Andrew Sewell, who will start work this fall. Dr. Sewell is one of only about 100 physicians in the U.S. to complete a dual-residency in psychiatry and neurology. Dr. Sewell and I have an important opportunity to explore whether or not LSD and/or psilocybin offers prophylaxis against cluster headache. There are some medications that do help stop this type of headaches, but they are not fully effective for many and there are no medications on the market that can actually prevent the cycling course of cluster-type headaches. Most people know of tension headache and migraine; cluster headache is more rare and can be extremely severe, lasting weeks to even months at a time! Recently, MAPS was approached by a cluster headache patient advocate who has collected anecdotal information on dozens of individuals reporting very positive results from their personal experimentation with LSD and psilocybin. Furthermore, MAPS has received a donation of $50,000 from David and Marsha Weil toward clinical research into this reported treatment.
Over this summer, Dr. Sewell and I plan to write up a case series for publication in a medical journal to call greater attention to what these individuals report. We plan to start the protocol design and drafting process for a study on cluster headache later this fall, as well. Success on all these fronts will mean that we are finally able to perform clinical research that will investigate, over a five to ten year period, whether MDMA, LSD, and psilocybin have an important and credible role in the current pharmacopeia for the specific issues that we are investigating.
While officially no research has been approved yet at my institution, these projects are actively in the works. Especially with your help, we could soon convert these efforts into clinical research. On behalf of everyone involved in these projects, I cannot thank the MAPS membership enough.