On Oct. 2, Jordanian Principle Investigator Nasser Shuriquie, M.D., attended a workshop with the Jordanian Food and Drug Administration (JFDA) to enhance his knowledge about clinical research procedures in preparation for conducting our Jordanian MDMA/PTSD study. On Sept. 20, the last of the necessary documents were submitted to the Jordanian Ethics Committee (the Jordanian version of an Institutional Review Board) at Al-Rashid Hospital for review. We have had conditional study approval since spring, but were asked to submit several updated documents to the Ethics Committee. The documents include our most recent investigator’s brochure and insurance statements. We have purchased insurance for the subjects, and liability insurance for the therapists and research staff. We are in the process of obtaining insurance for the Clinical Research Organization (CRO) we have hired to monitor the study. After the Ethics Committee reviews and approves the protocol, it will be submitted to the JFDA. From Oct. 22-24, MAPS Executive Director Rick Doblin, Ph.D., will be in Jordan. While there, he will meet with Dr. Shuriquie, other therapists and administrators from the Al-Rashid Hospital, and staff at Antaea Medical Services, Ltd., the CRO that will monitor the study. Our partnership with the CRO allows us to rely on a local group to monitor the study. At the same time, the CRO is sharing study responsibility. The Jordanian study has led MAPS to make a major contribution to the PTSD treatment field—we are creating the first Arabic version of the Clinicians Administered PTSD Scale (CAPS), the world’s leading measure of PTSD. Currently there is no Arabic version of the CAPS. We’ll first fund the translation of the English version into Arabic. We will then have the Arabic translation retranslated back into English, making any necessary corrections should the original English version differ from the translated version. Luz, a U.S. translation company, will then certify the final version. We will then donate the Arabic version to The National Center for PTSD, which created the original version of the CAPS. We’re hoping that the availability of an Arabic version of the CAPS will facilitate other PTSD studies and treatments in the Arab world.
