Marin: IRB Approves Study Protocol; Submitted to FDA

On August 6, 2014, the protocol for our new study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness was submitted to the Institutional Review Board. 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. Principal Investigator Phil Wolfson, M.D., is a currently practicing psychiatrist with substantial experience using MDMA in psychotherapy before MDMA was criminalized in 1985. On August 21, the protocol was submitted for review to the Research Advisory Panel of California. On September 5, the IRB gave conditional approval for the study, pending one final point related to subject privacy. Once this final discussion with the IRB has been completed, the protocol will be submitted to the Food and Drug Administration and Drug Enforcement Administration for review. Read Dr. Wolfson’s published 1986 article on MDMA-assisted psychotherapy in the Journal of Psychopharmacology.