MDMA Research News
1. Israeli Ministry of Health Approves MDMA/PTSD Study
On June 1, 2011, Israel's Ministry of Health approved our Israeli study of MDMA-assisted psychotherapy for PTSD. This approval indicates that the Ministry was satisfied with our response to their April 28 request for additional information. Now that the study has the full approval of Israeli regulatory bodies, we have begun preparing to submit the protocol to the US FDA, which must prospectively approve the study before we can start enrolling subjects since it is being conducted under a US Investigational New Drug application. The study initiation will take place in approximately one month, during which time we will finalize the study insurance documents and contracts with the study site. Training materials containing the measures to be used in the study have been provided to the investigators and independent raters, and we continue working with clinical research organization Antaea Medical Services, Ltd., to prepare the remaining documents and forms.
2. FDA Approves New MDMA/PTSD Relapse Study
On May 24, 2011, the FDA approved our study of MDMA-assisted psychotherapy for up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. After participating in our initial study, subjects were interviewed using the Clinician Administered PTSD Scale (CAPS), a diagnostic tool used by psychiatrists and researchers to assess the severity of PTSD symptoms. At the two-month follow-up after treatment, over 80% of subjects no longer met the diagnostic criteria for PTSD. In the long-term follow-up (conducted an average of 41 months after treatment) we found that CAPS scores had declined even further, demonstrating that benefits persisted over time. For several of these subjects, however, some symptoms did eventually return. The new study will be limited to these subjects, and is intended to determine whether a single additional open-label MDMA-assisted psychotherapy session can be effective for eliminating these relapse symptoms.
The FDA approval came just one week after the agency received our protocol submission on May 17—the fastest turnaround we have ever seen for an FDA protocol approval. This expediency could be attributable to the fact that the risks of treatment are low: Eligible subjects have already been through treatment and been shown to tolerate MDMA in a clinical context.
3. Data Finalized for Swiss MDMA/PTSD Study
On June 1, 2011, MAPS' clinical research team completed their quality inspection of the database for our Swiss study of MDMA-assisted psychotherapy for PTSD. The database has been closed and locked (with a 0.04% error rate, far below the 0.5% required to pass), officially concluding the data collection phase of the study. With the final data set ready, the research team can now begin analyzing the data and assisting the investigator in preparing a manuscript to be published in a peer-reviewed scientific journal. The article will be co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The locked database will also be used for our final report to the US FDA.
4. Health Canada Completes Pharmacy Inspection for Canadian MDMA/PTSD Study
On May 10, 2011, officials from Health Canada completed their inspection of the Vancouver pharmacy that will be used to store the MDMA capsules to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. According to Canadian regulations, the pharmacy must have adequate security and accountability before we can be granted a license to import MDMA from Switzerland in Canada. Health Canada has told us to expect the results of the inspection before the end of June. Once the import license has been approved, we will submit the final study documents to Health Canada and schedule the study initiation. We have now been working for about two years (since Health Canada approved the protocol) to obtain the import permits for the study, and we are hoping to start this study soon.
5. First Subject Unblinded in US MDMA/PTSD Veterans Study
On May 20, 2011, the first subject was unblinded in our ongoing US Phase 2 study of MDMA-assisted psychotherapy for PTSD in veterans of war. Now that the research team knows which dose of MDMA the subject received (low, medium, or high), they can determine whether the subject is eligible to participate in Stage 2 of the study or continue on to the long-term follow-up portion of the study. Stage 2 involves giving the subject an additional MDMA-assisted psychotherapy session, and is reserved for those subjects who received either low ("active placebo") or medium dose of MDMA in Stage 1 in order to provide all subjects with the same opportunity to experience the effects of a full dose. If the subject received a full dose of MDMA, they will advance to the long-term follow-up portion of the study in which treatment effects (if any) are evaluated 12 months following treatment by the re-administration of the Clinician Administered PTSD Scale (CAPS). This study is our first to compare the safety and effectiveness of three (rather than two) different doses of MDMA in combination with psychotherapy. All MAPS MDMA/PTSD studies with the exception of our completed Phase 2 pilot study have used active placebos in order to effectively maintain the study blind.
6. Training Manual Completed for Independent Raters in MDMA/PTSD Studies
The increasing number and global reach of MAPS' MDMA-assisted psychotherapy studies means that maintaining consistency of therapeutic approach across study sites is essential. In light of this challenge, MAPS has created a training manual for the blinded independent raters involved in our studies of MDMA-assisted psychotherapy for PTSD. The purpose of this manual and its accompanying video tutorials is to provide instruction in the reliable administration of the Clinician Administered PTSD Scale (CAPS), the primary outcome variable in our studies used to evaluate the severity of PTSD symptoms before and after treatment with MDMA-assisted psychotherapy.
The CAPS was one of the first diagnostic interviews developed specifically for PTSD. Because of the flexibility of the CAPS interview format, there can be differences between how interviewers use it to evaluate PTSD symptoms. By standardizing how these interviews are conducted and scored, we will obtain more consistent data and in doing so enable our research staff to conduct meta-analyses and compare data across sites—of major importance when conducting international clinical trials.
The manual will enable our independent raters to (1) identify symptoms of PTSD, (2) understand the history and purpose of the CAPS, (3) become familiar with the features of the CAPS, (4) become familiar with techniques in completing the CAPS interview, (5) understand the benefits and limitations of using the CAPS for assessing the effects of exposure to traumatic events, and (6) score the CAPS interview reliably and effectively. Based on training materials provided by the US Veterans Administration, the manual was collaboratively developed by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., MAPS Research and Information Specialist L. (Ilsa) Jerome, Ph.D., and MAPS Clinical Program Manager Amy Emerson. Videos of real CAPS interviews will be used to assess the effectiveness of the training manual.
7. PTSD Diagnostic Scale Translated for Middle East MDMA/PTSD Studies
With our Israeli study approved and our Jordanian study awaiting final government approval, we have been working hard to make our research tools accessible to clinical researchers in the Middle East. One of these tools is the Clinician Administered PTSD Scale (CAPS), which is the primary measure used by our researchers to determine the severity of PTSD symptoms before and after treatment. MAPS has now completed the translation of the CAPS into both Hebrew and Arabic, and we are working on back-translations which will verify the accuracy and consistency of the translations. By sharing these translations freely with the Veteran Administration's National Center for PTSD, and with researchers throughout Israel and the Arab world, MAPS is promoting the development of effective PTSD treatments by fostering collaborations between international research teams and across different cultures.
Other Research News
8. Last Subject Treated in Swiss Study of LSD-Assisted Psychotherapy for End-of-Life Anxiety
On May 26, 2011, the 12th and final subject was treated in MAPS' Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness. Once we collect follow-up data from this subject in July, we will have completed the first clinical LSD study in a patient population in over 35 years, representing a major milestone in the renaissance of psychedelic research. In 30 treatment sessions, not a single subject experienced severe negative reactions (serious adverse events, or SAEs) such as psychotic experiences, suicidal crises, flashbacks, or severe anxieties (bad trips). According to Clinical Investigator Peter Gasser, M.D., all 12 patients reported benefits from the treatment—however, it is too early to say whether the results will be statistically significant. Regardless of statistical significance, however, the preliminary results indicate that the risk of administering LSD in carefully controlled clinical settings is acceptably low, and that there is a promising future for LSD research. You can also read more about the historical significance of this study in David Jay Brown's May 27 article, "Landmark Clinical LSD Study Nears Completion."
9. New Study of Ibogaine Treatment for Addiction Planned for New Zealand
MAPS has agreed to donate $15,000 to a new observational study of ibogaine treatment for addiction to take place in New Zealand, under the direction of Principal Investigator Geoff Noller, Ph.D., Research Fellow in Psychological Medicine at the University of Otago, NZ. This will be an investigator-sponsored study conducted with assistance from MAPS, and has been made possible by a generous $25,000 grant for ibogaine research from Matt and Kristi Bowden of Stargate International. This study will complement our ongoing ibogaine research program in Mexico, to which the remaining $10,000 of the Bowdens' donation will be allocated. Like our other observational ibogaine studies, this research will investigate the long-term effects of ibogaine therapy at independent treatment centers, perhaps up to three different New Zealand clinics. This data may be used to make a case for a possible future clinical study and to evaluate differences in treatment approach and effectiveness between clinics. We are expecting to submit study documents to a New Zealand ethics committee this summer, and anticipate initiating the study in late Summer or early Fall.
10. UK Researchers Seek Participants for Drug Experience Survey
A psychedelic research team at Imperial College London directed by Robin Carhart-Harris, Ph.D., and associated with David Nutt, M.D., is conducting a new study about individual experiences with specific drugs. You are eligible for this survey only if you have had at least one previous experience with all of the following drugs: cannabis, alcohol, ketamine, magic mushrooms, and amphetamines. The survey is available online.
11. Wellcome Trust Considers Accepting Grant Application for UK MDMA/PTSD Study; May Convene Advisory Meeting
On May 19, 2011, British psychiatrist and psychopharmacologist David Nutt, M.D., met with officials from the Wellcome Trust, the philanthropic organization that is considering whether to allow us to submit a grant request for a proposed MAPS-sponsored UK study of MDMA-assisted psychotherapy for PTSD. In this meeting, Wellcome officials explained that the study, which would be coordinated by Dr. Nutt, would need to have a significant neuroscience component in order to be eligible for funding. They also expressed concerns about how UK psychology and PTSD researchers would view Wellcome Trust support of the study. In order to gauge how such support would be received, Wellcome is considering holding a small meeting later this year of UK and perhaps also international experts to discuss the potential of drug-assisted psychotherapy. This is a promising move, since it indicates that the foundation is taking our proposal seriously. However, it also highlights Wellcome's ongoing concerns about their reputation in the research community. We will be invited to submit a grant application only if they determine that supporting psychedelic psychotherapy research is more of a "reputational opportunity" than a "reputational risk."
12. Psychiatric Times: Does MDMA Have a Role in Clinical Psychiatry?
On May 6, 2011, MAPS Clinical Investigator Michael Mithoefer, M.D., published an article in the Psychiatric Times about the current state of research into the therapeutic potential of MDMA. Dr. Mithoefer describes the history of MDMA's use in psychiatry, the most recent results from MAPS' studies of MDMA-assisted psychotherapy for PTSD, the risks and benefits of MDMA for therapy, and the mechanisms by which MDMA is believed to help people confront trauma and overcome anxiety. Dr. Mithoefer's extensive experience administering MDMA-assisted psychotherapy to PTSD sufferers suggests to him that "MDMA may find an important place in the future of psychopharmacology."
13. American Botanical Council: FDA Accepts Protocol for Study on Marijuana and PTSD
The latest edition of the American Botanical Council's quarterly peer-reviewed journal HerbalGram (Volume 8, Number 6, June 2011) contains a thorough and well-researched article on the FDA's April 28, 2011, approval of MAPS' planned study of smoked and/or vaporized marijuana for PTSD in 50 veterans of war. The article presents a nuanced summary of the background, rationale, design, and outlook for what could become the first controlled clinical trial of the therapeutic potential of marijuana for PTSD. "I wasn't surprised with FDA's favorable review since I have come over the last two decades to respect the FDA's willingness to put science over politics," explains MAPS Founder and Executive Director Rick Doblin, Ph.D. "Still, it's breathtaking every time FDA gives us permission for a new precedent." Now that the FDA has given the study its stamp of approval, it falls to the National Institute on Drug Abuse/Public Health Service to conduct their own redundant and politically-motivated review process (existing for marijuana but not for research on any other drug) to decide whether to allow us to purchase the marijuana we need for the study at cost from NIDA.
14. Cell: Cannabinoid System Offers New Therapeutic Possibilities and Challenges
The most recent edition of Cell Chemistry and Biology (Volume 18, Issue 5, May 2011) includes a feature article by Chandra Shekhar entitled "Mixed Signals: Cannabinoid System Offers New Therapeutic Possibilities As Well As Challenges" on the history, promise, and challenge of MAPS' medical marijuana research. The article briefly outlines the history of cannabis research, and explains how the marijuana plant has been the key to one of the most significant medical discoveries of the last century: the endocannabinoid system. While private companies and government agencies have invested a great deal in developing medicines based on isolated and synthetic versions of the active chemicals in the marijuana plant, research on the safety and effectiveness of the marijuana plant itself still lags behind. The article explains how naturally-occurring cannabinoids help regulate some of the most important biological functions, and how modern researchers—including MAPS—are trying to learn which delivery systems and which cannabinoid combinations work best for which conditions.
15. Details Announced for MAPS Canada Benefit Events This Fall
On September 13, 2011, MAPS Canada will host a benefit event in Victoria, BC, for our Canadian study of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD and for MAPS Canada's study of ayahuasca treatment for addiction. "Out of Mind: The Therapeutic Applications of Psychedelics to Treat PTSD and Addiction" will take place Tuesday, September 13, from 7:30-9 PM at Alix Goolden Hall, located at 907 Pandora Avenue in Victoria, BC. Hosted by Philippe Lucas, M.A. (research affiliate at the Center for Addictions Research and member of the Victoria City Council and the Board of Directors of MAPS Canada), speakers will include Rick Doblin, Ph.D. (MAPS Founder and Executive Director) and Gabor Mate, M.D. (physician and author of In the Realm of Hungry Ghosts: Close Encounters with Addiction). Advance tickets ($20) will be available starting in July at locations to be announced, and will also be available at the door ($25; $10 for students with valid identification). Event sponsors include the Center for Addictions Research of British Columbia (CARBC), Indoor Jungle, Sacred Herb, Sunset Room, and the Beyond Prohibition Foundation. The event will also be streamed live online, so stay tuned for more information. All proceeds will go toward MAPS Canada's research into the therapeutic applications of MDMA-assisted psychotherapy and ayahuasca.
Additional details about our September 18 fundraising event in Vancouver, BC, are forthcoming. Also keep an eye out for more information about our upcoming events in the Pacific Northwest, happening on September 20 in Portland, OR, and September 21 in Seattle, WA.
16. MAPS Discusses Psychedelic Research and Education with Student Activists
On Monday, May 23, MAPS Development Associate Brian Brown delivered a presentation to Students for a Sensible Drug Policy (SSDP) at Kalamazoo College, Michigan. The presentation covered the history of MDMA, including its discovery by Alexander Shulgin, its dissemination in the field of psychotherapy, the social circumstances that made it illegal in 1985, and the founding of MAPS one year later. The presentation emphasized the MDMA-assisted psychotherapy protocol that MAPS has designed for treating PTSD, outlined MAPS' efforts to develop marijuana and psychedelics into prescription drugs, discussed MAPS' perspective on psychedelics' role in social change, reviewed recent media coverage of MAPS and psychedelic psychotherapy. During his visit, Brown encouraged students to educate themselves, share their knowledge, and engage local government and media to look closely—with facts, not fear—at the potential for psychedelics in medicine. MAPS thanks Kalamazoo College and SSDP for their generous honorarium, which will be used to support MAPS' psychedelic and medical marijuana research and educational projects.
17. European Ayahuasca Research Symposium Convenes in Amsterdam June 17
On June 17, 2011, an international group of scholars and scientists will convene in Amsterdam for the European Ayahuasca Research Symposium, a one-day lecture series exploring the current state of research into the medical, therapeutic, and spiritual uses of ayahuasca. Ayahuasca is a psychedelic brew made from plants native to the Amazon Basin. Long used as part of shamanic ceremonies, over the last few decades ayahuasca has been gaining increasing recognition as a ceremonial rite, a neuroscientific tool, and as a potential treatment for addiction. The symposium is presented by the OPEN Foundation and co-sponsored by MAPS, COGnITO, and the Núcleo de Estudos Interdisciplinares sobre Psicoactivos (NEIP). See the EARS website for program details as well as time and location information.
18. Special MAPS Discount for 2011 Science and Nonduality Conference This October
On October 19-23, 2011, the Science and Nonduality Conference will take place at the Embassy Suites and Marin Center in San Rafael, CA. SAND 2011 will gather together over 60 of the world's leading scientists, spiritual leaders, authors, and teachers to explore the concept of "time" through the integrated perspectives of modern science, ancient tradition, art, philosophy, and experience. MAPS will be sponsoring a panel at the conference where scientists and other members of the MAPS community will discuss the conference theme from the perspective of psychedelic research. Speakers will include Stanislav Grof, John Hagelin, Richard Rohr, Gangaji, David Peat, Zoketsu Norman Fischer, Michael Harner, Rabbi David A. Cooper, Fred Alan Wolf, and many others.
MAPS supporters can also take advantage of a special offer: Receive $45 off registration simply by entering the coupon code MAPS when ordering your tickets. To learn more, visit the Science and Nonduality website.
19. Speakers Announced for Horizons Psychedelics Conference in NYC
Speakers have now been announced for Horizons: Perspectives on Psychedelics, an interdisciplinary conference taking place on October 14-16, 2011, 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 include ethnopharmacologist Dennis McKenna, Ph.D., MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Institute of Transpersonal Psychology co-founder James Fadiman, Ph.D., and more. Tickets are on sale now.