On December 15, 2014, the Research Advisory Panel of California (RAP-C) approved the protocol and informed consent documents for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. The U.S. Food and Drug Administration approved the protocol on November 13. 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. The final step before we can begin screening subjects will be to obtain the Schedule I license from the U.S. Drug Enforcement Administration, which we do not anticipate to be a major hurdle. Thank you to the over 600 people who helped support this study by attending our sold-out screening of Dying to Know, a new film by Gay Dillingham about Timothy Leary and Ram Dass’ life and friendship. View the study protocol…
