On April 30, 2013, the U.S. Food and Drug Administration approved the protocol design for our pioneering study of MDMA-assisted therapy for social anxiety in autistic adults. The Advice Letter (pdf) from the FDA requested several changes to the exclusion criteria involving subject safety, some of which we thought were not necessary based on existing scientific literature. We have prepared an amended protocol incorporating some of these changes, along with evidence for why we don’t think the other changes are necessary. Once the FDA has reviewed and approved this amendment, we will submit the protocol and study materials for review by the Institutional Review Board at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study.
