The Investigator's Brochure

Volume 1 of the Investigator's Brochure has already been submitted to FDA on October 1, 2001, as part of the initial IND application #63,384 for Dr. Mithoefer's MAPS- sponsored pilot study of MDMA-assisted psychotherapy in subjects with chronic posttraumatic stress disorder (PTSD). Update #1 of the Investigator's Brochure, dated January 20, 2003, and Update #2 of the Investigator's Brochure, dated July 16, 2004, are being submitted as part of this application for Dr. Halpern's MAPS-sponsored pilot study of MDMA-assisted psychotherapy in subjects with anxiety related to a diagnosis of advanced-stage cancer.