Great news for the future of MDMA’s role in psychotherapy.
On March 13, 2015, the U.S. Drug Enforcement Administration approved the Schedule I license for Phil Wolfson, M.D., the Principal Investigator for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. This was the final regulatory approval needed for the study, which was approved by an Institutional Review Board (IRB) on September 16, 2014, the Research Advisory Panel of California (RAPC) on December 15, 2014, and by the U.S. Food and Drug Administration on November 13, 2014. Located in Marin, Calif., this study will gather preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety in 18 subjects diagnosed with a life-threatening illness. “Obtaining DEA approval was the last step in the complex, arduous, and lengthy process of getting approval for our study,” reports Dr. Wolfson. “We are undoubtedly the first ever study to be located in an investigator’s home in the history of DEA approvals.” The study site is now preparing for initiation and to begin screening subjects.