Sponsor/Principal Investigator: John Halpern, M.D.
Location: McLean Hospital, Harvard Medical School, Belmont, MA (USA)
Dr. Halpern is the Sponsor/Investigator. In his FDA IND application, he cross-referenced MAPS’ IND for MDMA and MAPS will have full access to the data generated from his study. MAPS conducted the design and protocol approval process for this study through a direct gift to McLean Hospital. This study of twelve subjects was also being conducted under US FDA IND and has received IRB approval and DEA registration.
One subject completed the experimental treatment. A second subject participated in the first of two experimental sessions before dropping out due to a decision to resume chemotherapy, which required them to drop out since the study was only for people who were receiving only palliative treatments. No additional subjects were enrolled and the study was closed due to enrollment challenges.
Protocol submitted to FDA on November 26, 2004 (PDF format)