Summer 1994 Vol. 05, No. 1 Politics and Protocols: In Search of a Balance
MDMA-assisted psychotherapy, by virtue of its ability to help people experience and integrate difficult and complex emotions, may prove uniquely valuable in the treatment of patients suffering from PTSD. Anecdotal reports of the therapeutic use of MDMA by Vietnam Vets and rape victims are encouraging. Yet anecdotal reports are not sufficient to prove scientifically that MDMA is beneficial, and without scientific proof the FDA will not even consider a request to make MDMA available to psychiatrists and psychotherapists for the treatment of PTSD.
In late 1992, Dr. Manuel Madriz Marin, the chief psychiatrist at the Military Hospital in Managua, Nicaragua, contacted MAPS. Dr. Madriz requested support from MAPS for a clinical trial he wanted to conduct into the use of MDMA-assisted psychotherapy in the treatment of soldiers and civilians traumatized during the Nicaraguan Civil War (see MAPS, Vol. 4, No. 3, p. 3). Dr. Madriz’s project is exactly the sort of research that MAPS was created to facilitate, and I enthusiastically offered MAPS’ help.
DETERMINING THE FEASIBILITY OF THE PROJECT
My first task was to assist Dr. Madriz in obtaining permission for his study from the Nicaraguan Ministry of Health. To support Dr. Madriz’s efforts, I mailed him a large collection of scientific papers evaluating MDMA’s safety and efficacy to submit to the Ministry. These papers included information from standard 28-day safety studies in the dog and the rat that MAPS funded in 1986. The FDA requires these animal toxicity studies as prerequisites before human studies with any drug are normally permitted. To supplement the scientific data, Dr. Madriz prepared a rough draft of a research protocol. After some months of discussions with officials in the Ministry of Health, Dr. Madriz was assured in writing by the Nicaraguan Minister of Health that permission would be granted for his study.
The second essential task was to locate a source of MDMA for the study. In 1986, MAPS had contracted with Dr. David Nichols of Purdue University, Department of Medicinal Chemistry to manufacture MDMA for research purposes. MAPS’ initial animal toxicity studies were conducted with some of this material, with the rest remaining in storage at Purdue awaiting future projects. Since MAPS intends to submit whatever data is gathered from the Nicaraguan study to the FDA, it is imperative that the MDMA used in the experiment be approved by the FDA as genuine and pure. Using the MDMA manufactured by Dr. Nichols would resolve any concerns the FDA might have over the nature of the drug itself, assuming that the MDMA had not deteriorated over the eight years it has been in storage. Fortunately, MDMA is a very stable molecule when kept out of excessive heat, light or moisture, and when Dr. Nichols retested it there were no signs of deterioration.
Though pure MDMA was available for research purposes, legally shipping it from the United States to Nicaragua requires permissions from the governments of both the United States and Nicaragua. Preliminary discussions with officials in the DEA’s International Drug Unit, Office of Diversion Control, indicated that there are established procedures for exporting drugs from the US to other countries for research purposes. I learned that it would be possible to obtain all the necessary approvals for doing so if the appropriate official in the Nicaraguan Ministry of Health were to provide an import permit for the MDMA. Dr. Madriz was able to determine that the Minister of Health would provide an import permit once the final draft of the protocol was submitted for her review and we knew exactly how much MDMA would be required for the study.
The last preliminary hurdle involved the issue of funding. This issue has now also been resolved, as a result of the unfortunate inability of Dr. Evgeny Krupitsky to obtain permission for a MAPS-sponsored project involving MDMA research in Russia. In April, 1993, MAPS received a donation of $28,000 to support a project investigating the use of MDMA in the treatment of alcoholism and neurosis in Russia. The study was to be conducted under the direction of Dr. Krupitsky at the St. Petersburg Regional Dispensary of Narcology, a 600 bed in-patient alcoholism treatment facility. Due to the political turmoil in Russia, Dr. Krupitsky was unexpectedly unable to obtain permission for his study. After trying for over a year to obtain permission, Dr. Krupitsky reported that in April, 1994 he was no closer than when he began (see MAPS Vol. 4, No. 4, p. 9). While political factors delaying permission for research are nothing new, Dr. Krupitsky felt unable to say when, if ever, the situation would change. Dr. Krupitsky graciously suggested that MAPS consider reallocating the funds from his project to Dr. Madriz’s research, raising additional funds for his Russian project were permission to be granted. After consultation with the original donor for Dr. Krupitksy’s project, the funds were shifted to the Nicaragaun study.
THE PROTOCOL DESIGN PHASE
With the availability of funding and legal permissions, the project has shifted into the protocol design phase. MAPS has been extremely fortunate to receive the assistance of Sylvia Garma, Ph.D., an expert in PTSD who speaks fluent Spanish. The protocol design phase is the key to the success of the entire project. When working with such a controversial subject as the therapeutic use of a psychedelic drug such as MDMA, the scientific design of the study has to be able to withstand exhaustive critique, both from sincere skeptics as well as from people ideologically opposed to psychedelic drug research. Compounding the protocol design process are differences in research methods between Nicaragua and the United States, uncertainty about whether PTSD is diagnosed identically in the US and in Nicaragua, and the lack of availability in Spanish of some important outcome measures.
While the protocol design has not been finalized, some basic design elements are likely. Dr. Madriz’s current treatment for PTSD involves patients coming from all over Nicaragua to his hospital for a three week in-patient treatment program. The MDMA study will also use a three week in-patient treatment program. There will be two experimental groups, an MDMA group and a randomized matched control group that will not receive MDMA. Those patients who receive MDMA during their treatment will probably be administered two sessions, the first at the end of the first week and the second at the end of the second week. This schedule will give the patients a week to get comfortable with the therapeutic team before their first MDMA session, a week between MDMA sessions, and a week to integrate their experiences before leaving the hospital. The two groups will receive the same sort of overall treatment, with the control group receiving two special therapeutic sessions of the same length of time as the MDMA sessions but without any drug. Music might be substituted, or perhaps more talk therapy.
MAPS-SPONSORED PTSD RESEARCH SEMINAR IN MANAGUA
As a result of their discussions about protocol design, Dr. Madriz and Dr. Garma decided that it was important for Dr. Garma to come to Managua to offer a four-day seminar on PTSD research. The seminar is scheduled for August 1-5. It will be attended by Dr. Madriz’s research team which includes two psychiatrists in addition to himself, two psychologists, several graduate students in psychology, and other staff members of the hospital. Joining Dr. Garma in offering the seminar will be a psychiatrist from New York also fluent in Spanish, Dr. Lleni Pach.
The seminar will focus on a series of issues related to treatment and research with PTSD. These include: 1) evaluation/ diagnostic issues ; 2) psychometric evaluation; 3) group and individual therapy; 4) family therapy; 5) broad outline of PTSD treatment; 6) clinical demonstrations of the use of measures and interviewing technique with in-patients in Dr. Madriz’s PTSD unit.
The therapeutic use of MDMA in PTSD will be covered in a separate seminar later in the year, when Dr. George Greer and Richard Yensen, Ph.D. travel to Managua to help further train the Nicaraguan research team. Dr. Greer has conducted pioneering MDMA research in the US in the early 1980’s, and Dr. Yensen, who speaks Spanish, researched LSD and MDA in the mid-1970’s. Their seminar will include discussions about MDMA- assisted psychotherapy and will also offer guided MDMA sessions for the research team. In that way, the research team will gain a theoretical understanding of how to work with MDMA along with an experiential understanding of the effects of MDMA.
FINANCIAL DETAILS
As you can see in MAPS’ financial report (page X), MAPS spent $3,479 on this project in FY 1993-1994. Of that sum, $1,259 was sent to Dr. Madriz for a fax and modem so that we can exchange documents faster than by mail, which can take a long time in Nicaragua (this price includes hefty Nicaraguan import taxes); $120 was spent on translating two documents from Dr. Madriz into English; $2,100 was sent to Dr. Madriz to pay for a translator to translate several outcome measures into Spanish, a telephone line for the modem, copies of various documents, filing fees for the protocol, and for Dr. Madriz’s expenses to go to a 1994 Latin American Psychiatric Conference in Panama where he spoke about the protocol. Since the end of MAPS’ fiscal year on May 31,1994, an additional $1,568 was spent on airplane fares to Nicaragua for Dr. Garma and Dr. Pach, making the total spent on this project $5,047 to date. Dr. Garma, Dr. Pach and Dr. Madriz have so far donated their personal time for this project.
HOPEFUL TIMETABLE
If all goes as rapidly as I would like (when has that ever happened?), the protocol design process will be completed by the end of August. Obtaining permission to export MDMA to Managua for the experiment will hopefully take only a month or so after the protocol is completed, with the MDMA arriving in October. The MDMA psychotherapy seminar could then take place in Managua in late October or early November. If the first patient is treated with MDMA before the end of 1994, I’ll be satisfied.
By the end of 1995, if the results of the pilot study are encouraging, I hope that additional studies will be initiated in the United States, most likely at several VA centers, and also in Israel. We shall see…..
