News from the Front Lines of MDMA ResearchThree FDA-approved research studies in the U.S.
MDMA Research in other countries - Switzerland, Israel and Spain
Personal Accounts of Healing with MDMA • Book: "Through the Gateway of the Heart"
|
MAPS' website offers updated information about efforts to develop MDMA into a prescription medicine. Of special interest are MAPS' website also offers links to harm reduction information, ecstasy pill-testing results and pill submission information. October 17, 2002. A Surprising New Issue. After reviewing MAPS' letter, Dr. James Baldwin of the WIRB informed RIck Doblin that the October 30 meeting was canceled, but not for the reasons MAPS had hoped. Dr. James Baldwin said that the meeting was "premature" because the WIRB now needed to convene its Executive Policy Committee (EPC) to discuss whether the WIRB should be involved with research with Schedule I drugs. The next EPC meeting is scheduled for November 19. The WIRB is no longer reviewing the protocol based on the science but on non-scientific, internal policy issues, not a very encouraging development. October 11, 2002. A Comprehensive, Strong Response. MAPS submitted a lengthy written response to the WIRB letter, along with 14 letters of information and support from MDMA scientists around the world. MAPS' letter addressed every point raised in the WIRB letter and was so solid that we thought perhaps the WIRB would conclude that the October 30 meeting was not necessary. October 3, 2002. A Glimmer of Hope. Rick Doblin speaks with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin apologized for the tone of the WIRB letter and seemed to view favorably MAPS' arguments. He was informed that the one scientist whom the WIRB letter claimed was against the study was actually in favor of the study (subject to two conditions that MAPS could easily agree with), that the second scientist cited in the WIRB letter was strongly in favor of the study, and that the third scientist was probably not fully informed about the details of the protocol and was neither opposed to or in favor of the study. Dr. Baldwin tentatively scheduled a meeting between Rick Doblin and Michael Mithoefer and the WIRB for October 30, in Olympia, Washington. September 27, 2002. Outrageous News. Dr. George Ricaurte publishes an article in Science reporting on primate data that he claims suggests that even one night's recreational use of Ecstasy can lead to Parkinson's. This government-funded research, which ignored the high mortality rate of the test animals and directly contradictory human data, is a classic example of risk amplification and the demonization of illegal drugs. MAPS obtained a copy of this article before publication and responded by sending out our first press release ever. MAPS' critique was favorably reported in articles in the New York Times and Washington Post and elsewhere. MAPS has also written a letter to the editor of Science. September 6, 2002. Terrible News. The Western IRB, which approved the MDMA/PTSD protocol on July 10, informed us by letter that approval was withdrawn. The revocation was based on secondhand reports of conversations (not on data!) that a WIRB staff person had with three MDMA researchers. The WIRB letter was written in a surprisingly insulting manner and contained numerous mistakes. MAPS was not informed that the protocol was being reevaluated and did not have an opportunity to respond to the reports by the WIRB staff person, who didn't like the fact that the WIRB had approved the protocol. July 17, 2002. Tremendous news. On July 10, we received word that the Institutional Review Board (IRB) had approved MAPS' MDMA/PTSD study! We can now definitely say that the US study will take place. Dr. Michael Mithoefer still needs to obtain his DEA Schedule 1 license, which should take about 4-6 weeks, but this is just a matter of time There is now an excellent chance that the Israeli Ministry of Health will approve an Israeli MDMA/PTSD study. Michael and I are tentatively planning to go there in late Sept. or early Oct. for a one-day seminar organized by the Ministry to discuss the latest findings in MDMA research, and protocol design options for the Israeli study. Here are the financial implications: We still need to raise an additional $60,000 for the US MDMA/PTSD study and another $60,000 for the Israeli study. MAPS is also seeking $10,000 for our National Institute of Mental Health (NIMH) grant application for support for the development of a treatment manual that describes in detail hw MDMA-assisted psychotherapy for PTSD should be conducted and provides specific ways to evaluate whether the therapy technique itself is being delivered appropriately. We are also seeking $20,000 for our ongoing MDMA literature review. Any help or suggestions would be greatly appreciated. June 19, 2002. MDMA/PTSD protocol submitted to the Western Institutional Review Board (WIRB). Review expected to take 3-5 weeks. June 14, 2002. FDA gives final approval to conduct the treatment sessions in Dr. Michael Mithoefer's office, with a "crash cart" and an Emergency Room doctor and nurse in the next room in case they are needed. May 14, 2002. Conference call with Dr. Mithoefer, Rick Doblin and FDA o fficials, in which we come to tentative agreement to conduct the study in Dr. Mithoefer's office, as long as we hire both an ER doctor and nurse to sit in the room. May 10, 2002. FDA rejects our request, primarily saying that they would like a larger emergency response team. March 14, 2002. Request submitted to FDA to change the location of the treatment sessions from the Medical University of South Carolina (MUSC) to Dr. Mithoefer's office. We propose renting a "crash cart" and hiring an emergency room nurse to be on site in the room next to the treatment room for the first five hours of each session, in case Dr. Michael Mithoefer and Annie Mithoefer, R.N. need help responding to an adverse event. November 28, 2001. The fourth patient in the Spain MDMA/PTSD dose-response study was treated on November 28, 2001. We have now completed the 50 mgs dose group (3 patients received 50 mgs and 1 received a placebo). The next dose level is 75 mgs (5 patients will receive 75 mgs and 2 will receive a placebo).
November 2, 2001. It's my pleasure to report some excellent news. About 10 AM, Friday, November 2, FDA contacted me to say that MAPS' MDMA/PTSD protocol was approved. This approval marks the culmination of 16 years of efforts to obtain permission from FDA for MDMA-assisted psychotherapy
research, since MDMA was criminalized in 1985. This approval also marks the
beginning of what I hope will be a $5 million, 5-year project to develop MDMA
into a prescription medicine.
October 1, 2001. MAPS submitted to the FDA today the protocol for Dr. Michael
Mithoefer and Dr. Mark Wagner's MAPS-supported pilot study into the use of
MDMA-assisted psychotherapy in the treatment of patients who have experienced
criminal victimization and as a result have suffered from chronic,
treatment-resistance posttraumatic stress disorder (PTSD). The submission of
this protocol to FDA marks a major milestone in the history of MAPS, and
hopefully in the history of MDMA research. FDA has 30 days to respond to the
protocol. We fully expect FDA eventually to approve the study in some form.
July 18, 2001. As part of its submission to FDA of a protocol designed to study the use of MDMA in the treatment of PTSD, MAPS' commissioned an extensive review of the scientific literature on MDMA. This literature review was developed under the direction of Matt Baggott with Ilsa Jerome, Ph.D., and is now being made available to regulatory agencies, other researchers and the public. The literature review will be updated on a regular basis as new research is published. July 16, 2001. A draft of the MDMA/PTSD protocol that MAPS has been working for 2 years to develop, with Dr. Michael Mithoefer and Mark Wagner, Ph.D., at the Medical University of South Carolina, has now been posted to the web. The protocol will submitted to FDA shortly after NIDA's scientific meeting on MDMA, held at the National Institutes of Health campus in Bethesda, MD, on July 19-20. If and when it becomes approved in some form, this protocol will be the first FDA-approved study of the therapeutic use of MDMA since MDMA was placed in Schedule 1 in 1985.
March 19, 2001. The US Sentencing Commission held an open hearing concerning its proposal to increase penalties on MDMA. Testimony about MDMA opposing the increase was presented by Rick Doblin, Ph.D., David Nichols, Ph.D., Charles Grob, M.D., Julie Holland, M.D. and Richard Glen Boire, Esq. Testimony about legal issues by opponents of the increase was presented by Ed Mallet, Executive Director of the National Association of Criminal Defense Lawyers (NACDL), Julie Stewart, Executive Director of Families Against Mandatory Minimums (FAMM), and Bill McColl, Legislative Director of The Lindesmith Center/ Drug Policy Foundation (TLC/DPF). The testimony had little effect and the Sentencing Commission recommended substantial increases in penalties. MDMA is now, dose for dose, punished more heavily than heroin. February 3, 2001. MAPS convened a protocol design meeting in San Francisco to discuss the details of a protocol evaluating the use of MDMA-assisted psychotherapy in the treatment of Post-Traumatic Stress Disorder (PTSD). The meeting included. among others, the principle investigator and therapists of the South Carolina team (Dr. Michael Mithoefer and Annie Mithoefer, RN), the MAPS team that has for the last year and a half been reviewing the MDMA literature for submission to FDA (Matt Baggott, Ilsa Jerome), the team that has been creating the MDMA bibliography of all scientific papers on MDMA published in peer-reviewed journals (from erowid.org), and scientific consultants including Dr. Charles Grob, Dr. George Greer, and Dr. Dave Nichols. The meeting was quite productive, with the protocol expected to be submitted to FDA in April 2001. November 9, 2000. The first patient was treated in the MAPS-supported MDMA/PTSD study being conducted in Madrid, Spain, under the director of José Carlos Bouso, Ph.D. candidate. José Carlos and Marcela Ot'alora were the co-therapists. The four hour session went very well and the patient seemed to have gotten to a deeper, more therapeutic level. Of course, we won't know for some time whether the patient received a dose of 50 mgs or a placebo! What we do know is that study is off to a great start. Read more about this study, including the protocol and informed consent form. November 1, 2000. Journal of the American Medical Association (JAMA) letter reports on the DanceSafe/MAPS pill testing program (the letter says people paid for their own testing but that was a mistake. MAPS paid for most of the testing of these pills). August 15, 2000. A discussion about "Raves, Ecstasy and Youth" was held at the Shadow Convention 2000 in Los Angeles. A celebrity panel of MDMA researchers, experts and psychonauts was assembled by the Lindesmith Center/Drug Policy Foundation; video and audio coverage of this unique event can be found at the Shadow Conventions 2000 website. May 5-6, 2000. The California Association of Toxicologists held a conference in North Hollywood, California, the first day of which was devoted to drugs that are commonly found at raves. Read summary and comments by Earth and Richard G. Boire. March 2000 - New York Lindesmith Center. Hear in RealAudio MDMA ('Ecstasy') Research: When Science and Politics Collide. Sound quality is excellent except for the first few minutes, so be patient. Speakers: Julie Holland, MD, attending psychiatrist, Bellevue Hospital Psychiatric Emergency Room and faculty, NYU School of Medicine; John P. Morgan, MD, professor of pharmacology, City College of New York; and Rick Doblin, president, MAPS) and Ph.D. candidate, Kennedy School of Government, Harvard University, assessed scientific and political efforts to conduct MDMA research in the US and abroad. See also the transcript of Holland's talk. February 2000 - Spain. A pilot study of MDMA therapy in the treatment of PTSD has been approved and will be the first formal therapy study with MDMA ever conducted. (Read current update. MAPS has pledged $54,000 for this study; we have raised $23,000 and are seeking additional contributions. Autumn 1999 - MAPS Israel MDMA Conference. MAPS organized an international symposium on the medical utility of MDMA. Talks from this event, held August 31 to September 1, 1999, are posted on this site (talks by George Greer, Juraj and Sonja Styk and Mark Kleiman). See also Video clips of some of the talks. July 24, 1999 - Teleconference with FDA concerning MDMA psychotherapy research to treat anxiety, depression and pain in cancer patients. FDA indicates willingness to approve "proof of principle" study. MDMA was synthesized in 1912 and patented in Germany by Merck in 1914 but was not the subject of human research at that time. In the 1950s it was briefly researched by the U.S. Government as part of the CIA's and the Army's chemical warfare investigations. It was forgotten until the middle 1970s when it was rediscovered by the psychedelic therapy community and began to be used as an adjunct to psychotherapy by psychiatrists and therapists who were familiar with the field of psychedelic psychotherapy. MAPS published a book, The Secret Chief, about the leader of this therapy community. In the early 1980s, the drug began to be used non-medically, particularly in Texas, under the name Ecstasy. Both the non-medical and therapeutic use of MDMA were made illegal in 1985 despite the Drug Enforcement Administration Administrative Law Judge Francis Young's recommendation that physicians be permitted to continue to administer it to their patients. Rick Doblin, Alise Agar and Debby Harlow helped coordinate the pro-MDMA contingent in the DEA lawsuit. For an excellent history of the early use of MDMA, see Pursuit of Ecstasy by Beck and Rosenbaum. In 1986, with the goal of developing MDMA's therapeutic potential through FDA-approved protocols, a non-profit organization opened a Drug Master File for MDMA with data gathered from the standard preclinical animal toxicity studies required by FDA. Five different applications for permission to conduct research with MDMA were submitted to FDA between 1986 to 1988, to the Neuropharmacologic Drug Products Division directed by Dr. Paul Leber. All five applications were rejected. Three protocols for double-blind controlled trials were from researchers at, respectively, Harvard Medical School, UC San Francisco Medical School, and U. of New Mexico Medical School, and were all rejected. Two applications submitted by individual physicians were for single case studies, one for a terminal cancer patient who had been successfully treated for pain with MDMA-assisted psychotherapy prior to the criminalization of MDMA and the other for a unipolar depression patient for whom all available treatments had been attempted without success. Both of these single-patient INDs were also rejected. The FDA based its rationale for rejecting all protocols and single case studies on the hypothetical risk of functional consequences of potential neurotoxicity from MDMA Proponents of MDMA research claimed that the rejection of all efforts to conduct FDA-approved MDMA research was based not on rational risk/benefit assessments but on an underlying cultural prejudice against medical research with drugs that were criminalized and on one or more FDA officials' personal opposition to human research with psychedelics. Since FDA Review Divisions are sometimes described as operating like fiefdoms under the control of their Directors, proponents felt profoundly stymied. Proponents claimed that concerns about MDMA neurotoxicity, which numerous studies had failed to link with functional or behavioral consequence and which in any case had not been clearly demonstrated to occur at all at therapeutic does levels, were reminiscent of scientific research in the 1960s that claimed to prove that LSD damaged chromosomes. These reports were effective in generating public disapproval of LSD and in hindering research but were later determined to have no clinically significant effect. In 1992, FDA reviewed a MAPS-supported protocol submitted by Dr. Charles Grob, then at UC Irvine, for a study of the use of MDMA in the treatment of pain, anxiety and depression in cancer patients. FDA's Drug Abuse Advisory Committee recommended that the cancer patient study be postponed and that a Phase 1 dose-response safety study be conducted first. The protocol was redesigned, with FDA giving final approval for the Phase 1 safety study on November 5, 1992. The safety study was completed in 1995. Data from the safety study revealed no unusual risks and indicated that MDMA could be safely administered within a clinical research context. Dr. Grob submitted the first draft of the protocol for the study of cancer patients in 1997. Negotiations with FDA moved very slowly, due to initial FDA decisions to put MDMA psychotherapy research on a slow track to nowhere. However, FDA opposition eventually lessened as MAPS and Dr. Grob persisted in our efforts to obtain permission for research into the use of MDMA-assisted psychotherapy in cancer patients. Doblin founded MAPS in 1986 when it became clear that only through FDA-approved research would MDMA ever become legal again. After years of effort, the first FDA- approved research with MDMA was finally approved in 1992 under the direction of Dr. Charles Grob, Harbor-UCLA.
MDMA is off-patent and is considered to be an
Orphan Drug, meaning that the
pharmaceutical industry sees no financial incentives in conducting research with it. As a
result
of the non-medical use of MDMA, funding from government agencies for studies into the
beneficial uses of MDMA have not been obtainable. MAPS has been working to support
MDMA research since 1986 and opened a Drug Master File for MDMA at the FDA. Opening
a Drug Master File is a required step for any drug before it can be legitimately researched
in the U.S. MAPS
has spent over $170,000 on MDMA research since 1986 and has supported FDA-required
animal toxicity studies at the University of Arkansas and Stanford (1986-1988), human
safety studies at Stanford and Johns Hopkins (1988-1991), and Dr. Charles Grob's
FDA-approved Phase 1 study into the physiological and psychological effects of
MDMA in humans (1992-1995).
MDMA with Cancer Patients - U.S. Research The proposed study of MDMA psychotherapy in the treatment of cancer patients (Harbor UCLA Hospital) will be the first investigation of the therapeutic potential of MDMA ever conducted in the U.S. We have assembled an excellent team of scientific advisors including Dr. Lester Grinspoon of Harvard Medical School, Dr. Carl Simonton, the developer of the Simonton method of treating the psychological aspects of cancer, and Dr. Jeanne Achterberg, an advisor on guided imagery to the National Institutes of Health's Office of Alternative Medicine, the senior editor of the Journal of Alternative Therapies, and the past president of the Association for Transpersonal Psychology. The rationale for the proposed study is based in part on numerous remarkable anecdotal accounts of the therapeutic use of MDMA in the treatment of cancer patients. An excellent description of the effect of MDMA is that it "reduces the fear response to a perceived emotional threat." MDMA promotes feelings of peacefulness and acceptance that enable people to move through denial and defense in order to respond clearly to difficult realities and to experience complex emotions. Clinical case reports suggest that MDMA can reduce acute and chronic pain experienced by end-stage cancer patients, perhaps that portion of total pain and suffering resulting from emotional, psychological, cognitive, and social variables. In one case reported by Greer, the debilitating pain associated with multiple myeloma was significantly alleviated during an MDMA session in which the patient practiced visualization techniques for pain control. A dramatic reduction in pain persisted for several months following the MDMA session. To date, no scientific studies have been attempted to evaluate the safety, efficacy or mechanism of action of MDMA as an adjunct to the reduction of pain in end-stage cancer patients, as a treatment of anxiety and depression, or as a tool to facilitate psychologically-mediated stimulation of the immune system. FDA-approved research in the US The only three FDA-approved studies where researchers have administered MDMA to human subjects have been "Psychobiologic Effects of MDMA in Humans" at Harbor-UCLA, "MDMA Pharmacokinetics in Humans" at UCSF, and "Serotonin and Dopamine system interactions in the reinforcing properties of psychostimulants" at Wayne State University. See our psychedelic research list MDMA section for current updates about these three studies.MDMA Research in other countries MAPS is currently supporting the efforts of researchers in Switzerland, Israel and Spain. The proposed studies in Spain and Israel are for MDMA psychotherapy in the treatment of post traumatic stress disorder (PTSD). MAPS tried to start MDMA/PTSD research in Nicaragua from 1993 to 1995. When it became clear that research in that country would not be sufficiently rigorous, MAPS abandoned the effort.
|