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MDMA/PTSD therapy study approved in SpainSpain has joined Switzerland and Germany as a European country where studies with psychedelics are actively developed by a small group of researchers. On December 20, 1999, Jose Carlos Bouso, Dr. Pedro Sopelana and Dr. Maria Angeles Corral met with the Spanish Ministry of Health to discuss their MDMA/Post Traumatic Stress Disorder (PTSD) protocol. The Ministry requested several changes, most notably lower doses (high dose is now 150 mg, not 175 mg) and the elimination of the use of a booster dose several hours after the initial dose. A revised protocol for the initial dose-finding study was submitted to the Ministry on December 27, 1999. The Ministry approved the study February 7, 2000. This will be the first controlled study of the therapeutic use of MDMA ever conducted. It is a dose-finding study that will hopefully lead to a larger trial. The subject group will be women survivors of sexual assault. The authorized experimental design's outline is as following:
Group 1: 50 mg of MDMA (3 subjects), placebo (1 subject) MAPS has pledged $54,000 over two years for the investigators to complete this study. Half of this sum has been raised; we are looking for additional support for this effort. Donors will be contributing to the first controlled study of the therapeutic use of MDMA ever conducted. See MAPS 9(3) 1999, page 11
The interaction of MDMA and alcoholA clinical pharmacology study looking at the interaction of MDMA (100 mg) and alcohol (.8 g/kg) has been completed. The results have been published in Life Sciences: Pacifici R, Zuccaro P, Farré; M, Pichini S, Di Carlo S, Roset PN, Ortuño J, Segura J, de la Torre R. Immunomodulating properties of MDMA alone and in combination with alcohol: a pilot study. Life Sci 1999; 65(26): 309-316. The research team is continuing research into the interaction of MDMA and alcohol.
Israel MDMA/PTSD study in developmentProtocol development for the $50,000 PTSD study that MAPS is working to start at Ben Gurion University of the Negev is still underway. We hope to submit if for review to the Israeli Ministry of Health by the end of Summer 2000. See Bulletin 8(2) 1998
Over 700 scientific papers on MDMA reviewed and summarizedA major review of over 700 papers comprising all peer-reviewed articles reporting on basic and clinical research with MDMA will soon be completed by Matthew Baggott, Research Associate, Drug Dependence Research Center, UCSF. Baggott has been working under contract to MAPS to prepare this review, which is formatted according to FDA guidelines. The review will be submitted to the FDA in conjunction with the MDMA research protocol being planned at Harbor-UCLA Hospital under the supervision of Dr. Charles Grob. The review will also be submitted to the Israeli Ministry of Health as part of the application for the MDMA/PTSD study in Israel.
MAPS grant goes to Swiss MDMA researcherMAPS has awarded an $11,000 grant to PhD candidate Alex Gamma to write up the data for several MDMA studies completed at the University of Zürich. The first of these has been published: Gamma A, Frei E, Lehmann D, Pascual-Marqui R, Hell D, Vollenweider FX (2000). Mood state and brain electric activity in Ecstasy users. NeuroReport 11(01) pp 157-162. Three additional studies of Ecstasy users vs. controls will be completed over the next year: differences in memory performance using an Auditory Verbal Learning Test, differences in acoustic startle reflex and prepulse inhibition (PPI) of the startle reflex, and differences in selective attention as measured by the Stroop task.
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