MDMA Research News
1. FDA Accepts Protocol for Planned Study of Marijuana for PTSD
On April 28, 2011, the U.S. Food and Drug Administration accepted MAPS' protocol design for our study of marijuana for symptoms of PTSD in war veterans, stating that our revised protocol successfully addresses their previous concerns, pending information on the source of the marijuana to be used. Once again, the FDA has demonstrated its willingness to evaluate studies on the basis of scientific merit rather than political partisanship.
Although both MAPS and the FDA are satisfied with the protocol design, we cannot begin the study until it passes yet another review process with the National Institute on Drug Abuse/Public Health Service (NIDA/PHS). This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research. NIDA/PHS must review and accept the protocol before allowing us to purchase marijuana from NIDA. This process is biased from the start, since NIDA's mission does not include exploring the potential beneficial uses of marijuana.
MAPS has been pressuring the federal government through hearings, lawsuits, and appeals for over a decade to allow us to grow our own marijuana. The DEA has refused to accept the recommendation of its own Administrative Law Judge that it would be in the public interest for Professor Lyle Craker of the University of Massachusetts, Amherst, to receive a license to grow marijuana for research regulated by the FDA. We're now waiting for the final ruling to come from the DEA. We will then sue yet again in the DC Circuit Court of Appeals and make an even stronger case against the federal obstruction of research and for the need for state-level reform.
Many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans.
2. Psychedelic Education Program to Train Next Generation of Psychedelic Therapists
With MAPS preparing to expand its research program to move even closer towards regulatory approval of MDMA as a prescription medicine, there will be more need for therapists trained in MAPS' approach to MDMA-assisted psychotherapy than ever before. Phase 3 of our research program—involving scores of therapists and over a dozen studies in multiple countries—will begin in earnest in 2015.
The MAPS Psychedelic Education Program will provide access to knowledge about the history, methodology, and potential applications of psychedelic-assisted psychotherapy not available through traditional educational channels. Professional credit (CE/CME) will be available for qualifying medical practitioners. Those interested in receiving information about the Psychedelic Education Program as it becomes available may fill out and return a Psychedelic Education Profile.
Some (but not all) of those who participate in the Psychedelic Education Program may be invited for additional training in our psychedelic therapist training study, which treated its first subject on April 22 (see next item). We are not actively recruiting subjects for this study, as it is currently limited to individuals already involved in our MDMA-assisted psychotherapy research projects.
Keep watching for announcements about workshops at our upcoming 25th Anniversary, taking place December 9-11 in the San Francisco Bay Area. These workshops will be a great opportunity for anyone interested in learning more about psychedelic therapy and harm reduction, including but not limited to those who want to remain involved in the Psychedelic Education Program.
3. First Subject Treated in MDMA-Assisted Psychotherapy Training Study
On April 22, the first subject was treated in our training study for MDMA-assisted psychotherapy researchers. The protocol was designed as a Phase 1 study of the psychological effects of MDMA administered in a therapeutic setting to healthy volunteers. We are not actively recruiting for this study, participation in which is limited to individuals selected to be investigators in MAPS' MDMA-assisted psychotherapy studies. In addition to providing new information about the effects of MDMA-assisted psychotherapy in healthy volunteers, the study will enable us to train therapists to conduct our MDMA/PTSD studies. With MAPS preparing to expand its research program to move even closer towards regulatory approval of MDMA as a prescription medicine, there will be more need for therapists trained in MAPS' approach to MDMA-assisted psychotherapy than ever before. The study is led by Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. Julie Holland, M.D., is the official medical monitor. We need your support to complete this study, which costs about $8,500 per subject. Please consider contributing today and help make sure that future MAPS studies have the trained, qualified clinicians they need.
4. Israeli Ministry of Health Requests More Information about Planned Study
On April 6, the Israeli Ministry of Health reviewed our proposed protocol for our Israeli study of MDMA-assisted psychotherapy for PTSD. This protocol was originally submitted to the Ministry on March 15 after being approved by the ethics committee. On April 28, the chair of the ethics committee received a letter from the Ministry of Health (PDF; Hebrew) requesting more information about the study prior to approval. Briefly, the Ministry has asked us to provide:
We are now collaborating with the Israeli clinical team to draft a response to this request. Once we submit the response and the Ministry is satisfied, we expect that they will approve the protocol.
- More detailed data about the cardiovascular risks of MDMA, and the extent to which the site is equipped to handle these risks
- Information regarding possible or perceived conflicts of interests involving the Clinical Investigator
- A complete summary of the commercial and professional relationship between MAPS and the investigators
- Additional assurances about the objectivity of our research methodology
5. Swiss LSD Study Team Submits Annual Report to FDA; Study Nears Completion
On May 3, 2011, our clinical research team submitted to the FDA the annual report for our nearly-completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced life-threatening illness. Annual reports are designed to give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) applications. In our report, which covered all study activity between February 28, 2010, and February 28, 2011, we provided information about enrollment (including the total number of subjects enrolled for each study), demographics (such as height, weight, race, and illness), amendments to the study protocol, and the occurrence of serious and severe adverse events. Although there have been three serious adverse events over the course of the study, they were related to disease progression or accidents and not to administration of LSD.
On May 26, 2011, the 12th and last subject will undergo his last experimental therapy session. The MAPS clinical team is conducting a preliminary data analysis and finalizing the clinical database for the FDA. Statisticians at the University of Zurich working with Franz Vollenweider, M.D., will be conducting the analysis to assist Clinical Investigator Peter Gasser, M.D., in preparing a manuscript for publication.
6. MAPS Receives $25,000 Grant for Observational Ibogaine Study
On May 3, 2011, MAPS received a $25,000 grant for ibogaine research from Matt and Kristi Bowden of Stargate International. Stargate is a New Zealand harm reduction organization that sells legal alternatives to illegal drugs and develops new treatments for drug abuse, whose overall goal is to promote freedom from addiction. Matt is also a musician and activist committed to drug policy reform. MAPS' ibogaine research program—which includes both our ongoing observational study and our planned clinical study of ibogaine treatment for addiction—is an attempt to determine whether the potential risks and benefits of ibogaine-assisted therapy outweigh the risks of being addicted to alcohol, opiates, and other drugs. Unlike for MDMA, which numerous toxicity studies have determined can be safely administered in therapeutic contexts, basic clinical safety has not yet been established for ibogaine. Ibogaine therapy can be dangerous when administered without proper medical screening and other precautions. This donation will be used to support two observational studies of the long-term outcomes of ibogaine treatment, a new observational study in New Zealand, and MAPS' ongoing observational study at a Mexican clinic.
7. Synopsis and Budget Prepared for Proposed UK MDMA-Assisted Psychotherapy Study
Last month, we reported on the April 1 meeting of MAPS Founder and Executive Director Rick Doblin, Ph.D., British researcher Ben Sessa, M.D., Swiss psychiatrist and MAPS researcher Peter Oehen, M.D., MAPS therapist Verena Widmer, and two officials from the Wellcome Trust. Wellcome agreed to review a grant proposal from MAPS for a possible UK study of MDMA-assisted psychotherapy for PTSD. We have now completed an initial synopsis of the proposed study, as well as a preliminary budget. British psychiatrists David Nutt, M.D., and Ben Sessa, M.D., along with Sally Powell, are the tentative study investigators. Dr. Nutt will meet with Wellcome officials next week.
If the Wellcome Trust decides to fund our study, it would be modeled on our previous and ongoing studies but with an additional array of measures of physiological markers for PTSD, including tests for hormones related to stress and emotion, brain imaging, and cardiovascular and respiratory measures. This is the first time we have been able to propose a study measuring important neurobiological aspects of PTSD symptoms as they relate to MDMA-assisted psychotherapy treatment. Even more excitingly, it is also the first time a major foundation has welcomed a grant application for a study of MDMA-assisted psychotherapy.
8. Clinical Research Intern Wins Psychedelic Therapy Research Grant
MAPS Clinical Research Intern Katie Hendy, M.A., a doctoral student in Anthropology at UC Berkeley, was recently awarded a dissertation fieldwork grant by the Wenner-Gren Foundation, an organization that funds exceptional work in anthropology. The award will support her ethnographic research project on the practice and study of psychedelic therapy. Her research seeks to understand how the therapeutic and spiritual practice of using psychedelics has developed in the United States, and how clinical research with these drugs is taking this practice in new directions. With the return of psychedelic therapy to the mainstream becoming more of a reality, understanding where it has been and where it is going is more important than ever.
9. Speakers Confirmed for MAPS' 25th Anniversary
We would be delighted if you would join us for our 25th Anniversary Conference and Celebration, taking place December 9-11 in the San Francisco Bay Area. Celebrate our past successes and share our vision and plan for the future at multiple daytime and nighttime events. Festivities will include:
Continuing Education credit opportunities
Visionary art auction
Renowned authors, artists, scientists, and physicians
Unforgettable entertainment that will keep you dancing until sunrise
And some truly incredible surprises
So far, confirmed speakers include:
Rick Doblin, Ph.D.
Stan Grof, M.D., Ph.D.
Charles Grob, M.D.
Michael Mithoefer, M.D., & Annie Mithoefer, B.S.N.
Berra Yazar-Klosinski, Ph.D.
Dale Gieringer, Ph.D.
Donald Abrams, M.D.
Alex & Allyson Grey
Robert Venosa & Martina Hoffmann
Android Jones & Phaedra Ana
Formal invitations are forthcoming, so keep an eye out for more announcements.
10. MAPS Canada to Host Two Benefit Events This Fall
On September 13, 2011, MAPS will host a benefit event in Victoria, BC, for our Canadian study of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant PTSD and for MAPS Canada's study of ayahuasca treatment for addiction. Speakers will be MAPS Founder and Executive Director Rick Doblin, Ph.D., and Gabor Maté, M.D., author of In the Realm of Hungry Ghosts: Close Encounters with Addiction. Event organizer, Victoria City Councillor, and member of MAPS Canada Board of Directors Philippe Lucas will MC this event.
An additional event will take place in Vancouver, BC, on September 18, for our Canadian MDMA/PTSD study. More details about these events will be available soon. MAPS and MAPS Canada are working on beginning a study of MDMA-assisted psychotherapy for PTSD in Vancouver, and proceeds from both of these events will help make that study possible.
11. Transpersonal Pioneers Offer 6-Week Course on Psychology and Consciousness
From May 24 to June 28, 2011, join transpersonal psychiatrist Stan Grof, M.D., Ph.D., and transpersonal psychologist Christina Grof, Ph.D., for a six-week "tele-course" in honor of the achievements of these pioneering researchers. MAPS has signed on as an affiliate for this course, meaning that a significant portion of every registration made by clicking on the below links goes directly to supporting MAPS' research and educational projects. The course, entitled "Moving Toward Wholeness," includes weekly online seminars, including:
The course centers around a "Global Holotropic Breathwork Day" on June 11, during which practitioners of Holotropic Breathwork from around the world will "breathe as one" in an unprecedented collective healing event. This course is a rare opportunity to learn about research into altered states of consciousness and transpersonal psychology directly from the founders of the field, and is not to be missed. The course is co-sponsored by Wisdom University, the Association for Holotropic Breathwork International, the Grof Transpersonal Training Institute, and Stan and Christina Grof. Click here to register, support MAPS, and to learn more about this unique opportunity.
- Toward a Psychology of the Future: Lessons from Consciousness Research
- Cosmos, Psyche, and Society: Archetypal Forces in Personal and Collective Life
- The Power of Breath and Insight: Moving Toward Wholeness
- Bringing It Home: Integrating the Breathwork Experiences into Everyday Life
- Spiritual Emergency: Breakdown or Breakthrough?
- Celebrating Transpersonal Psychology: A Gathering of Elders
12. Tickets on Sale Now for Horizons Psychedelics Conference in NYC
On October 14-16, 2011, the "Horizons: Perspectives on Psychedelics" conference will be taking place at Judson Memorial Church in the heart of Greenwich Village in New York City. "Horizons" is an annual conference (now in its fifth year) the goal of which is to open a fresh dialogue on the role of psychedelics in medicine, culture, history, spirituality, and creativity. Speakers will be announced soon, and tickets are on sale now.
13. MAPS to Co-Host International Drug Policy Reform Conference in November
On November 2-5, 2011, the biennial International Drug Policy Reform Conference will take place at the Westin Bonaventure in Los Angeles, CA. Organized by the Drug Policy Alliance and co-hosted by MAPS, the Harm Reduction Coalition, Law Enforcement Against Prohibition, the Open Society Foundations, Students for a Sensible Drug Policy, and NORML, the three-day conference will bring together over 1,000 of the brightest minds from over 30 different countries in drug policy reform, harm reduction, medical marijuana, and psychedelic science. The conference will include a series of lectures and panel discussions with MAPS staff and researchers. The attitudes and assumptions underlying the war on drugs have a direct impact on how (and whether) psychedelic and medical marijuana research gets done, so don't miss this important event. Registration is now open!
14. Honor Thy Daughter by Marilyn Howell Now Available; Kindle Edition Released
Honor Thy Daughter, the new true-to-life psychedelic medical drama by Marilyn Howell, is now available from MAPS. Visit the book's website for excerpts, interviews, information about the author and cover artist, and resources related to cancer and psychedelic healing.
According to Stanislav Grof, M.D., Honor Thy Daughter "shows the value of psychedelic therapy as a tool for alleviating the suffering of cancer patients." According to Jean Kilbourne of the Wellesley Centers for Women, Howell "has been to the dark side of the moon…but she transforms it from a story of unfathomable loss and grief to one of love and hope." James Fadiman, Ph.D., writes that by showing the value of MDMA-assisted psychotherapy as an alternative to mainstream treatments, Howell's story "will hasten the end of an ill-conceived prohibition."
Just because we've been around for 25 years doesn't mean that we have trouble keeping up with the electronic age. Honor Thy Daughter is also now available on Amazon's Kindle. On Tuesday, May 3, MAPS sold its first electronic book.
15. MAPS Featured in ELLE and Good Times
Last month, in an article entitled "That Lovin' Feeling," ELLE magazine reviewed the origins of MDMA's therapeutic uses in marriage and family therapy and specifically discusses MAPS' role in helping psychedelic therapy return to mainstream medicine. The article is now available online, and includes an earnest and in-depth interview with MAPS Founder and Executive Director Rick Doblin, Ph.D., and discusses why—despite the possibility that MDMA-assisted therapy could also help couples reestablish lost connections—MAPS has chosen to focus on helping individuals overcome their traumatic pasts. Check out MAPS in the Media for this and even more evidence that psychedelic science is back in the mainstream.
Also, on April 13, 2011, Santa Cruz's Good Times magazine published an inspiring and engaging cover article interviewing David Jay Brown, regular guest editor for the MAPS Bulletin, award-winning Santa Cruz writer, and all-around psychedelic expert. In his interview, Brown talks about his own research on brain stimulation, psychedelics, and altered states of consciousness; his thoughts on consciousness and death; his deep friendships with such historical figures as Timothy Leary and Robert Anton Wilson; and the past, present, and future of psychedelic research.
16. Scientists Publish First Comprehensive Review of LSD Pharmacology
http://www.amazon.com/Pharmacology-LSD-critical-review/dp/0199589828" target="_blank">The Pharmacology of LSD: A Critical Review by Annie Hintzen, M.D., and Torsten Passie, M.D., Ph.D., is the first-ever comprehensive review of the biochemistry and psychopharmacology of LSD. After the discovery of its effects in 1943, lysergic acid diethylamide, or LSD, became the most extensively studied psychopharmacological agent in history and had a tremendous impact on neurotransmitter research. During the 1950s and 1960s, more than 5000 scientific articles were published about its pharmacology and psychological effects. Today, there is a resurgence of interest in LSD as a psychotherapeutic and neuroscientific tool. The introduction to the book is a concise overview of the history, politics, scientific use, and therapeutic potential of LSD. According to psychopharmacologist Leslie Iversen, Ph.D., of Oxford University (who writes the foreword to the book), "We should be grateful to the authors for their patient compilation of a huge literature...The subject has always raised controversies, but this volume provides a much-needed sober and neutral scientific account." Drawing on data from over 3000 experimental and clinical studies and including over 1000 references, this book is a unique and invaluable resource for anyone interested in better understanding this complex and controversial psychedelic compound.
17. MAPS Needs Your Old iPad, iPhone, or iPod Touch
MAPS has taken its tabling and outreach capabilities to the next level by utilizing the latest in mobile technologies, and we need your help. Using these devices we are able to accept donations, make sales, and stay on top of our record keeping much more easily than ever before. We are currently limited by the number of devices we have, so we are seeking additional in-kind donations of these devices from our members and supporters. We are especially seeking donations of iPads, though old iPhones and iPod Touch devices are also needed. Please visit MAPS' page at The Giving Effect to make your donation. Tax receipts will be issued for the current market value of each donated device.
18. Professional Credit Still Available for 2010 Psychedelic Science Conference Videos
MAPS and David Lukoff, Ph.D., of the Spiritual Competency Resource Center (SCRC) have teamed up to continue offering Continuing Medical Education (CME) and Continuing Education (CE) credits to qualifying physicians, psychologists, MFTs, nurses, and other healthcare professionals. All you have to do is watch the videos on the SCRC website and complete a short quiz. Courses include talks by psychotherapist Michael Mithoefer, M.D., psychedelic researcher David Nichols, Ph.D., psychiatrist Stan Grof, M.D., Ph.D., MAPS Founder and Executive Director Rick Doblin, Ph.D., and alternative health guru Andrew Weil, M.D. A portion of course fees goes directly to funding MAPS' research and educational projects. Take a course today and get professional credit while supporting MAPS!
19. Psychedelic Science Film Seeks Contributions
From Neurons to Nirvana: The Great Medicines is a new film about the science of psychedelics, including the connection between their neurochemical effects and their ability to change our consciousness. The film explores what that connection means for our understanding of ourselves, our relationships with others, and our understanding of the world. The film argues that the historical taboo against psychedelics is connected to a general fear of the ecstatic state— a state of mind that helps detach the self from the roles assigned to us by language and society—in Western cultures. Psychedelics have been seen as threatening drugs not because of their harmful physical effects (which appear to be quite limited), but because of their ability to so thoroughly throw into question our most basic assumptions about consciousness and identity. This film is currently under production, and needs further support to be completed. For each donation over $10, you will receive a complimentary DVD once the film is completed. Visit the film's website to learn more and contribute.
20. Help Build the World's First Psychedelic Art and History Museum
A small team has taken the first steps toward opening the world's first museum dedicated to psychedelic science and art. By showcasing art, memorabilia, and historical items, the museum will educate the public and serve as a community center and event space for the global psychedelic community. From their original use in psychiatry and medicine to the emergence of modern visionary art culture and the growth of mainstream psychedelic culture, the museum will objectively showcase the role that psychedelics have played throughout history.
21. New Documentary Project Explores Human Impact of War on Drugs
Framing drug policy as a criminal justice problem rather than a public health problem makes it more difficult to conduct research on scheduled substances like psychedelics and marijuana, but it also has direct effects on the lives on individuals. The Exile Nation Project, Charles Shaw's new oral history of the war on drugs, is an online archive of interviews, short films, and other features that will continue to grow over the next two years. Visit the film's website to learn what you can do to support this important project.