On February 7, 2012, the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD was submitted to an independent Human Research Ethics Committee (HREC). Subjects in this study will receive two experimental sessions instead of three (as in our U.S. flagship study), enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our future Phase 3 studies. Once HREC approves the protocol, it will be submitted to the Australian Therapeutic Goods Administration (TGA) for review.
As in our ongoing study in U.S. veterans, this study will compare the effectiveness of a full dose (125 mg) and a low dose (30 mg) of MDMA in combination with psychotherapy. Unlike our U.S. veterans study, this study will omit the medium dose (75 mg) in order to determine whether we can achieve an effective double-blind with a two-arm (low and medium dose) study.
One of the ways we are expanding our capacity to conduct international clinical trials is by working closely with international affiliates. MAPS is collaborating with the newly formed Australian non-profit organization Psychedelic Research in Science and Medicine (PRISM) to design, fund, obtain approval for, and conduct this first-ever Australian study of the therapeutic application of MDMA.