On April 6, the Israeli Ministry of Health reviewed our proposed protocol for our Israeli study of MDMA-assisted psychotherapy for PTSD. This protocol was originally submitted to the Ministry on March 15 after being approved by the ethics committee. On April 28, the chair of the ethics committee received a letter from the Ministry of Health (PDF; Hebrew) requesting more information about the study prior to approval. Briefly, the Ministry has asked us to provide:
- More detailed data about the cardiovascular risks of MDMA, and the extent to which the site is equipped to handle these risks
- Information regarding possible or perceived conflicts of interests involving the Clinical Investigator
- A complete summary of the commercial and professional relationship between MAPS and the investigators
- Additional assurances about the objectivity of our research methodology
We are now collaborating with the Israeli clinical team to draft a response to this request. Once we submit the response and the Ministry is satisfied, we expect that they will approve the protocol.