maps bulletin • volume xix number 2
1
MULTIDISCIPLINARY ASSOCIATION F
OR PSYCHEDELIC STUDIES
From the desk of Rick Doblin, PhD
VOLUME XIX NUMBER 2
T
The renaissance in psychedelic research
has been a satisfaction to work toward since I foundedMAPS in 1986, and a delight to actually witness andcelebrate. But eventually, like the bloom of youth,even a renaissance must either mature or stagnate and become irrelevant. We must grapple with and accept the end of the beginning, since when we started we just needed to assert claims of suppressed benetsto justify the renewal of research. Now, our researchagenda has grown to include Phase 2 pilot studies inwhich we must generate preliminary data to sup-port our claims of medical benet. The outcome of allthis work (whether or not we’re able to achieve legalprescription use) will be largely determined by our ac-tions these next several years. We now need to lay thefoundations for larger Phase 3 research studies that are required to prove safety and efcacy, ideally withsuch transparency of methodology and outcomes that the next steps will be clear to everyone. What beganas a mission to bring psychedelics (once again) to theattention of the scientic and psychotherapeutic com-munities, blossomed into something much larger andmuch more powerful.Over the last several months, I’ve felt the timewas approaching to shed my triumphant psychedelicrenaissance language, once glittery and fresh withthe imagery of renewal and birth. MAPS has recentlyachieved a psychedelic milestone that for me conrmsthat we’ve grown beyond the initial renaissance, beyond the return of the repressed, into the dissolvingof the boundaries between culture and countercultureand the crafting of initial, tentative, complementary,and integrative mergings that can be so healing andare so deeply needed by all concerned.This milestone was nally reached at the end of June, in the mountains of Austria. In an example of the increasing reach and professionalism of MAPS’staff, we gathered therapists from seven different countries (US, Canada, Switzerland, Germany, Spain,Israel, and Jordan) for a successful and emotionallynourishing debut of MAPS’ rst MDMA-assisted psy-chotherapy for the treatment of posttraumatic stressdisorder (PTSD) therapist training program. Thepurpose of the training program is to prepare thera-pists to conduct MAPS-sponsored Phase 2 and Phase3 psychotherapy studies in accordance with MAPS’MDMA/PTSD treatment manual. Over ve daysof programming, we featured progress reports anddiscussions of protocol designs, treatment methods,music for psychedelic sessions, and cultural consider-ations that can affect the therapeutic method.Perhaps surprising to some, I believe that thera-pists who administer MDMA to PTSD patients cando so effectively without ever having taken MDMAthemselves. MAPS will never require therapists work-ing on our studies to experience MDMA. At the sametime, I believe MDMA-naïve therapists who workwith MDMA could become even more effective afterthey have had a personal experience of the subjectiveeffects of MDMA when taken within a therapeuticcontext. The training program in Austria is prepar-ing us for our next major milestone—to develop aprogram to legally administer MDMA to therapists asan integral part of their training. (I look forward to re-porting positive news to you about this development sometime in the very near future.)In Austria, two days were devoted to watching anddiscussing videotapes of therapeutic sessions from ourUS, Swiss, and Israeli MDMA/PTSD studies. Sittingand watching therapy sessions, stopping the tapesevery few moments for commentary and critique fromour diverse and experienced group, was to me ourmost moving and effective teaching method. However,the sheer diversity of comments from the assembledtherapists about alternative interventions made mewonder whether we could ever rene our treatment manual so that the “best” therapeutic interventionowed directly and obviously from the principles
maps bulletin • volume xix number 2
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MAPS Conference: Psychedelic Sciencein the 21st Century
From April 15 to April 18, 2010, MAPS will be hosting“Psychedelic Science in the Twenty-First Century,” aninternational psychedelic conference in the San FranciscoBay Area. We will have continuing medical education(CME) credits available for psychiatrists, other physicians,psychologists, social workers and nurses. The conferencewill also be open to the general public. There will be twotracks of presentations at the conference: the CME trackwill have leading researchers presenting their evidence- based ndings from numerous studies that have recently,or are currently, taking place around the world, while thesecond track will have psychologists, artists, and other cul-turally intriguing presenters from the psychedelic commu-nity. There will be a special banquet on Saturday eveningto honor the lifetime achievements of psychedelic luminar-ies Alexander “Sasha” and Ann Shulgin.Conrmed speakers include: Stanislav Grof, MD; Alexander “Sasha” Shulgin MD; Ann Shulgin; Alex and Allyson Grey; Andrew Weil, MD; Michael Mithoefer, MD; Ann Mithoefer, BSN; Charles Grob, MD; Alicia Danforth,PhD candidate; David Nichols, PhD; Franz Vollenweider,MD; Torsten Passie, MD, PhD; Matt Baggott, PhD candi-date; Jose Carlos Bouso, PhD candidate; Peter Gasser, MD; Julie Holland, MD; Sergio Marchevsky, MD; FranciscoMoreno, MD; Peter Oehen, MD; Jordi Riba, MD; MicheleWeitz, BA; John Harrison, PsyD candidate; Jeffery Kamlet,MD; Clare Wilkins; June May Ruse, PhD; Ingrid Pacey, MD;Rick Doblin, PhD; Valerie Mojeiko; Amanda Feilding; BenSessa, MD; Caroline “Mountain Girl” Garcia; and others.Taking place at a lovely Holiday Inn (formerly aHilton) near San Jose International Airport, the conferencewill start with a reception on Thursday evening and willhave three days of programming through Sunday after-noon. The hotel was chosen for its reasonable prices andclose proximity to the airport and public transit. Registra-tion information will be available soon. To be placed on aregistration list, please send an email to: conference2010@maps.org.This will be a remarkable event that will be even moreremarkable if you join us!
Therapist Training Protocol Leads toPositive Teleconference with FDA
On June 22, 2009, MAPS submitted a protocol to FDA re-questing permission to administer a single MDMA-assistedpsychotherapy session to therapists as part of their train-ing to conduct MAPS’ MDMA/PTSD research. On July23, Rick Doblin, PhD, Michael Mithoefer, MD, and MAPSClinical Program Manager Amy Emerson had a produc-tive and positive teleconference with six members of FDA’sDivision of Psychiatry Products. The FDA ofcials made aseries of suggestions about how, from their perspective, wecould improve the protocol. They suggested that we writethe protocol so that it would more closely resemble a Phase1 safety study in normal (healthy) volunteers. The revisedprotocol will include more measures of the psychologicaleffects of MDMA on healthy participants. We plan to sub-mit the revised protocol in mid-August and should learn by mid-September if it’s approved.We learned that we could provide much in the wayof educational experiences during our recent therapist training seminar that took place in Austria, with thera-pists from seven different countries. Nevertheless, we also believe it will benet therapists who will be administer-ing MDMA to patients to achieve a personal or subjectiveunderstanding of MDMA’s effects when administeredwithin a therapeutic setting. The only way such an MDMAexperience can be legally provided to therapists is throughan FDA protocol designed to gather safety informationon the effects of MDMA. The protocol requires potentialparticipants to have rst successfully completed a non-drug therapist training program where they will watchvideo tapes and review our treatment manual. We believethis protocol will signicantly enhance our ability to traintherapists to work more effectively on our MDMA/PTSDstudies.While many people may doubt the feasibility of askingthe FDA to approve the administration of a Schedule 1drug to therapists in order to better understand the effectsof that drug, we have thus far been greatly encouraged byFDA’s suggestions and handling of this project. The FDAhas so far shown us that developing MDMA into a pre-scription medicine is a matter of science, not of politics. As
of the method. Fortunately, the entire program wasnot rigorously analytical since on the middle day, wescheduled a Holotropic Breathwork session to givethe group an experience of a non-ordinary state of consciousness and to provide experiential, emotionalrelease.Overall, the effort to teach made it even clearerthat we ourselves have a lot to learn. Nevertheless,creating our rst formal educational program forteaching the principles and practices of psychedelicpsychotherapy, specically MDMA-assisted psycho-therapy for PTSD, was a milestone that took over twodecades to attain and signies a maturing movement.I am excited to announce that on August 11, wereceived accreditation to provide continuing medicaleducation credits at our conference in April 2010—a conference that will undoubtedly mark anothermilestone in our educational path.In order for MAPS to continue to expand ourresearch and educational activities, we need yoursupport. Come join with us as we move beyond therenaissance, to the deeper integrations ahead.Rick Doblin, PhD, MAPS President rdoblin@maps.org
maps bulletin • volume xix number 2
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MAPS Podcasts
Have you heard a MAPS podcast recently? We areproducing new podcasts regularly now and you canhear them on our website or by subscribing on iTunes.long as we continue to operate with the highest standardsof research and data collection and to follow the guidelinesset forth by the FDA and the European Medicines Agency(EMEA), it will be the results of the research (and not ide-ology) that determines whether or not MDMA is approvedas a prescription medicine.
MAPS Prepares for New MDMA/PTSDStudy with War Veterans
MAPS is preparing a follow-up study to our US pilot studyof MDMA-assisted psychotherapy for the treatment of PTSD, conducted under the direction of MAPS-sponsoredresearchers Michael Mithoefer, MD, and Ann Mithoefer,BSN. This new study will enroll eight US veterans withPTSD from the wars in Iraq or Afghanistan.There are three purposes for conducting this study.The rst purpose is to see if veterans respond any differ-ently than those who suffer PTSD from sexual assault,sexual abuse, or victims of crime. Veterans made up a smallminority of subjects in the Mithoefers’ previous study (out of 21 subjects, only two were veterans). The EMEA haspublished guidelines for PTSD research that call for studieswith homogenous subpopulations of people who sufferfrom PTSD from different causes. This is to determine if thesame therapy can be administered across these subpopula-tions. It is possible that people with PTSD from different causes will require different therapeutic protocols forMDMA–assisted psychotherapy, or that some subpopula-tions could be unresponsive to MDMA-assisted psycho-therapy. If people with PTSD from different causes arefound to respond well to similarly designed protocols, thenwe can include all of these subpopulations in the largerPhase 3 multi-site studies. If we nd that the treatmentsare different, we will have to take this into considerationwhen designing the Phase 3 studies.The second purpose of this new study in veteranswill be to gather methodological information about howdifferent doses of MDMA succeed in creating an effectivedouble-blind study. The researchers and subjects in ourpilot study were often able to accurately guess when askedwhether subjects had received an active dose of MDMA oran inactive placebo. The new study of veterans involvesadministering doses of 125 mg, 75 mg, or 25 mg (with fourof the subjects randomized to receive 125 mg, two to 75mg and two to 25 mg). We will see if the use of these threedoses can be a successful double-blind study. We will alsolook to see if people who receive the higher doses showeda larger therapeutic effect than people who receive thelower doses.The third and nal purpose of the study is to enrollsome subjects previously excluded for risk factors such ashepatitis C and hypertension. There is not strong evidencethat MDMA poses greater risks to people with these healthconditions, but we excluded these factors from our rst pilot study in order to proceed cautiously and please ourInstitutional Review Board (IRB). The new protocol willinvolve special pre- and post-screening and monitoringplans to evaluate whether MDMA can be safely adminis-tered to people with previously excluded risk factors. If wecan safely enroll these subjects, then recruitment into ourPhase 3 studies will be faster since fewer subjects will beexcluded for risk factors.This protocol will be submitted to the FDA in Septem- ber. After it is submitted and approved by the FDA, it will be submitted to our IRB. We hope to have the rst subject enrolled before the end of November 2009.On March 4, 2009, MAPS’ MDMA/PTSD researchwas featured on military.com, a popular military website(read the full text of this article on the MAPS website:www.maps.org/media). Since then, numerous warveterans who wish to be in the study have contacted us.However, it is not clear whether all of them will pass thescreening process and some may no longer be interestedin participating by the time the study gets started. If youknow, or are yourself, a war veteran suffering from PTSDwho would be interested in participating in a study inCharleston, South Carolina, please contact MAPS at: ask-maps@maps.org.
12th and Final Patient Enrolledin Swiss MDMA Study
MAPS’ Swiss MDMA/PTSD study has enrolled the 12thand nal subject. Nine patients have completed thestudy; the 10th and 11th are currently in the treatment process. We estimate that the nal treatments will takeplace between three and six months from now, dependingupon whether the last subject gets placebo or MDMA. If asubject gets a placebo session, they will later have the op-tion to participate in Stage 2, where they will go throughthe entire treatment process again but will receive the fulldose of MDMA. This is called an “open -label” study. In thisway, these subjects serve as their own controls, as well as being part of a matched control group.The Swiss project is our second study of MDMA-assisted psychotherapy for the treatment of PTSD. Whilethe Clinician Administered PTSD Scale (CAPS) scoresin the Swiss research have not dropped as dramaticallyas they had in our US pilot study, a preliminary analysissuggests that we are likely to obtain statistically signicant results. The completion of this study will be yet anothermajor accomplishment for MAPS and for our supporters.The Swiss study differed from our US pilot study inseveral ways. Instead of using an inactive placebo as wehad in the US study, we used a low-dose active placebo of 25 mg of MDMA, followed by a 12.5 mg booster dose. Thepopulation in the Swiss study also differed from our USstudy in that the majority of subjects had PTSD resultingfrom accidents and natural causes, rather than from sexualor physical assault. The Swiss study is also smaller than ourUS study, which enrolled 21 subjects.
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MAPS Bulletin, summer 2009. Research Update 2009
Summer 2009 Vol. 19, No. 2 MAPS Research Update 2009
The MAPS Bulletin is published by the Multidisciplinary Association for Psychedelic Studies. It first appeared as the MAPS Newsletter, a one page letter in 1988. In… (More)
The MAPS Bulletin is published by the Multidisciplinary Association for Psychedelic Studies. It first appeared as the MAPS Newsletter, a one page letter in 1988. In… (More)
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