Marin: Study Protocol Submitted to IRB and RAP-C

On October 7, 2014, the protocol for our new study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness was submitted to the U.S. Food and Drug Administration for review. The FDA has 30 days (until November 7) to respond with comments, with no response indicating that the study may proceed. The Institutional Review Board approved the protocol on September 16. This randomized, double-blind, placebo-controlled Phase 2 study, located in Marin, Calif., 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 will be led by Principal Investigator Phil Wolfson, M.D. The study will also require approval from the U.S. Drug Enforcement Administration before we can begin screening subjects. The Research Advisory Panel of California (RAP-C) will review the protocol on November 19 (California is the only U.S. state with its own review panel for Schedule I drug research).