MDMA Dose Response Study in Cancer Patients with Anxiety

Investigator: John Halpern MD, Harvard Medical School and McLean Hospital, Belmont MA

Sponsor: Peter Lewis

Study of MDMA-assisted psychotherapy in subjects with anxiety as a result of advanced stage cancer, with outcome measures to evaluate anxiety, pain and quality of life. On February 23, 2004, MAPS donated $11,000 to McLean Hospital, Harvard Medical School, for Dr. Halpern's work on the protocol design and approval process ($15,000 was also donated to McLean for this study on June 2003). MAPS had initially worked with Dr. Charles Grob in a much earlier effort to conduct MDMA research in cancer patients prior to Dr. Grob's switching to psilocybin (see entry below). For more information about Dr. Grob's effort. see the details and reference page, the 1995 version of the protocol, and view the video. As of January, 2005, Dr. Halpern's study has now been approved by the McLean Hospital and Lahey Clinic IRBs, and the FDA has given permission (approved) the study as well. On March 7, 2006, the DEA has approved this study. MAPS has since withdrawn financial support for this study. A single participant completed the study and a second had one experimental session and then dropped out before the second session because of a desire to resume treatment for his illness. A case report is being written and will be complete by summer 2012.