U.S. Boulder Study: IRB Approves Amended Protocol; Site Prepares for Subject Screening

On April 5, 2013, an independent Institutional Review Board (IRB) approved the amended protocol and informed consent documents for our soon-to-be-initiated study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The amended protocol includes new study measures (the Dissociative Experience Scale II/DES-II and a Visual Analog Scale for Somatic Symptoms) and updated dosage information. We have also added additional study staff, including a new therapist and intern therapist. The FDA will now review the IRB-approved amended protocol while the site prepares to begin screening subjects.

Principal Investigator Marcela Ot’alora will give an update on the study’s progress at Psychedelic Science 2013.