MDMA/PTSD Israel Study

Israeli Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study has the approval of the Israeli Ministry of Health and Ethics Committee, and will be initiated pending clearance by the US FDA.

On January 10, 2011, our clinical team submitted the documents detailing our new protocol for our new Israeli study of MDMA-assisted psychotherapy for PTSD to the Institutional Review Board (IRB) at Beer Yaakov, Israel. On January 19, the ethics committee approved the protocol.

A revised protocol incorporating several changes to the study has been approved by the Israeli ethics committe. After reviewing the revised protocol, the ethics committee forwarded it to the Israeli Ministry of Health, which approved the study on June 1, 2011. The MDMA to be used in the study was previously imported for our earlier Israeli MDMA/PTSD study, so once the FDA has given its final approval we will have the initiation visit and start the study. We anticipate that it will be several months before we are able to begin treating subjects.

We closed our first Israeli MDMA/PTSD study on March 26, 2010, in order to provide more training to the therapeutic teams and to our independent rater, to improve our data collection processes, and to make several improvements to the protocol. There were no Serious Adverse Events (SAEs) and all patients had been treated without evidence of harm. We have reviewed the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond.

An official at the Israeli Defense Forces has indicated a willingness to refer soldiers with war-related PTSD once the new protocol clears the review process, which will help facilitate recruitment for the study.

New Israeli MDMA/PTSD Pilot Study Protocol (revised February 14, 2011)

View the timeline for this study.