Jordanian Study: Clinical Team Meets; Study Awaits Final Approval

On January 30, 2011, MAPS Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., led a one-day course for the therapists who will conduct the treatment sessions in our upcoming Jordanian study of MDMA-assisted psychotherapy for PTSD. Although the Jordanian therapists were trained in using our MDMA-assisted psychotherapy treatment manual prior to our April 2010 conference, the manual has since then undergone several revisions to its adherence criteria. The course gave them the opportunity to learn the new criteria and ask questions about their implementation.

The visit to Jordan was also a chance to gather the clinical team together in preparation for initiating the study once the Jordanian FDA has decided on insurance requirements for subjects enrolled in the study. These insurance requirements are necessary should subjects experience any negative effects as a result of study participation, a necessary legal precaution even though over 480 subjects have taken MDMA in clinical or laboratory research settings to date without evidence of a single drug-related Serious Adverse Event. Since this study will be the first psychedelic research in Jordan, the first time a non-profit drug developer has requested permission to conduct a study in the country, and the first time researchers have sought to use a drug administered just a few times as part of the therapeutic process, regulators in the country must develop a brand new set of research requirements. Once the Jordanian FDA has informed us about these requirements and approved the study, and we have obtained a permit to import the MDMA from Switzerland, we will be able to begin recruitment for the study.

On January 31, 2011, the Jordanian clinical team held an Investigators’ Meeting during which the lead investigators, therapists, and representatives from Antaea Medical Services (the clinical research organization hired by MAPS to monitor both our Israeli and Jordanian studies) discussed the process for initiating and conducting the study once it has cleared the Jordanian FDA review. Antaea will be responsible for monitoring the quality of the data gathered during the study, ensuring therapists’ compliance with the protocol, and ensuring that all the paperwork is in order in case the U.S. or Jordanian FDA decides to audit the study. The meeting included a welcome by MAPS Founder and Executive Director Rick Doblin, Ph.D., and Antaea CEO and Managing Director J.R. Roussos; a presentation by Dr. Mithoefer on the pharmacology and safety profile of MDMA; a presentation by MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., on the study protocol itself; and another by Antaea’s Kamila Novak on investigator responsibilities.