Institutional Review Board and State Advisory Panel Approve Protocol Changes
On September 30, the Research Advisory Panel of California (RAPC) approved the amended protocol for our upcoming study of MDMA-assisted therapy for social anxiety in autistic adults. The RAPC review is an additional layer of approval required only in California for research with Schedule I drugs. On September 25, the Institutional Review Board at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute also conditionally approved the amended protocol, pending our responses to some final questions (Update: The IRB fully approved the protocol on October 16.) The study will begin screening and enrolling subjects after the research pharmacy and principal investigator receive their Schedule I licenses from the Drug Enforcement Administration, for which applications were respectively submitted on October 2 and October 9. We anticipate that obtaining these licenses will be straightforward and that we will be able to begin screening subjects in early 2014. Charles Grob, M.D., and Alicia Danforth, Ph.D., are leading the study.