Research Updates - Spring 2000

MDMA/PTSD therapy study poised to begin in Spain

The Spanish research team has been joined by an American therapist experienced with MDMA in the treatment of post-traumatic stress disorder associated with rape. Marcela Ot'alora Roselli, bi-lingual therapist-in-training, currently lives in Boulder and is working on a masters degree at the Naropa Institute. Marcela decided to become professionally involved in MDMA therapy due to the contribution that MDMA therapy made to her own recovery from rape-associated PTSD. [ Read her personal account ]. The projected cost of this study is $54,000 to $63,000. Nearly half of this amount has already been donated to MAPS by members.
We continue to seek additional support for this effort. Donors will be contributing to the first controlled study of the therapeutic use of MDMA ever conducted. [ current update ].

Psilocybin in the treatment of obsessive-compulsive disorder

In May, MAPS sent a check for $10,527 to the University of Arizona Department of Psychiatry, to pay for the psilocybin for this historic study. Producing the psilocybin will probably take two to three months, then the study can begin. [ See the research protocol and informed consent form ]
This is the first FDA-approved study in over 25 years to examine the use of psilocybin in a patient population. The principal investigators, Dr. Pedro Delgado and Dr. Francisco Moreno, plan to study the use of psilocybin in ten patients suffering from obsessive-compulsive disorder (OCD). They want to determine if they can replicate in a clinical study several published case reports of patients whose OCD symptoms were reduced after self-experimentation with psilocybin mushrooms.

Matt Baggott and associates are nearing completion of a MAPS-funded major review of over 700 scientific papers comprising all peer-reviewed articles reporting on basic and clinical research with MDMA. 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.

Protocol development for the $50,000 post-traumatic stress disorder study that MAPS is working to start at Ben Gurion University of the Negev is still underway. We hope to submit it for review to the Israeli Ministry of Health before the end of the year.

At the MAPS symposium "Clinical Research with MDMA and MDE" held in Israel August 30-September 1, 1999, Dr. Efi Gouzoulis-Mayfrank presented data from a study comparing MDMA-using ravers with two control groups, one with subjects who had used cannabis but not MDMA and another with control subjects who did not use drugs. The mean estimated cumulative total dose of the MDMA-using group was 93 pills, the mean duration of regular use was 27 months.
Differences found were in certain subsets of memory and executive functions, with the MDMA-using group performing somewhat lower. These differences were statistically significant but clinically insignificant, meaning that neither the subjects nor the testers could tell the groups apart in normal social situations and the MDMA users' scores were still within the normal range.
Dr. Gouzoulis-Mayfrank's study was recently published in the Journal of Neurology, Neurosurgery and Psychiatry. The results have been sensationalized in the press with headlines such as "Study suggests even light use of Ecstasy might dull intelligence."
The memory findings in the studies of Drs. Bolla, Ricaurte and McCann are also statistically significant but clinically insignificant (MAPS Bulletin Vol. IX 3:6-8). Possibly confounding any causal role of MDMA in the memory findings is that these studies may be measuring effects of the Ecstasy raver lifestyle (lack of sleep, in some cases use of other drugs not matched by the control groups) or of possible preexisting factors such as subclinical depression and/or anxiety. However, the study of Dr. Gouzoulis-Mayfrank included no unusually heavy or poly-drug users.
As of yet, no study shows that one or a few doses of MDMA in a clinical research context results in any functional or behavioral consequences from possible neurotoxicity. Alex Gamma, Ph.D. candidate, University of Zürich, is reviewing all studies of MDMA and memory for a subsequent issue of the MAPS Bulletin. There is more that can be said about this topic, but we can't remember what it is.