On November 13, 2014, the U.S. Food and Drug Administration approved the protocol for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. This randomized, double-blind, placebo-controlled Phase 2 study, to be conducted in Marin, Calif., and led by Phil Wolfson, M.D., will gather preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety in 18 subjects diagnosed with a life-threatening illness. The study was approved by the Institutional Review Board (IRB) on September 16. On November 19, the Research Advisory Panel of California (RAP-C) is scheduled to review our responses to their request for several changes to the protocol and Informed Consent form, as California is the only U.S. state with a separate review process for Schedule I drug research. The study will also require approval from the U.S. Drug Enforcement Administration before we can begin screening subjects. Read April Short’s October 31 article about the study, and her November 6 Reset.me article, “Psychedelics Could Change the Way We Die.” View the study protocol…
