MDMA Research News
1. US Veterans MDMA/PTSD Study Continues Treating Subjects
As of October 21, 2011, our ongoing Phase 2 study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD has enrolled five out of 16 subjects. Three subjects have started the long-term follow-up portion of the study, and two are still in treatment. Two additional veterans have passed in-person screening, involving thorough assessments of PTSD severity and medical eligibility, with their treatment sessions soon to be scheduled. One subject has chosen to discontinue treatment after just one experimental MDMA-assisted psychotherapy session, reporting being cured and needing no further sessions.
2. New MDMA/PTSD Training Videos Under Development
Two essential parts of conducting methodologically rigorous and state-of-the-art MDMA-assisted psychotherapy research are standardizing the method of MDMA-assisted psychotherapy itself and the method by which data is collected about subjects' PTSD symptoms. We have standardized our treatment in our MDMA-assisted psychotherapy treatment manual and related adherence criteria. Having a consistent, reliable way to measure PTSD symptoms at baseline and over time during and after treatment is also essential.
MAPS has recently completed the development of a training manual for independent raters who conduct the Clinician-Administered PTSD Scale (CAPS) interviews in our international series of Phase 2 MDMA/PTSD pilot studies. The CAPS is the primary measure used by clinicians and therapists worldwide for evaluating the severity of PTSD symptoms, and is the principle measure we use to assess the effectiveness of our treatment method.
The CAPS training manual will be supplemented by video tutorials of CAPS interviews, drawn from actual recordings of interviews with subjects enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD in veterans of war. By building on the training materials provided by the U.S. Veterans Administration, creating Hebrew and Arabic versions of the CAPS through rigorous double back translation methods, and providing a uniform set of training tools for independent raters, we will be able to standardize how the CAPS is administered across study sites. This is a necessary step before moving on to the larger Phase 3 studies required for federal approval of MDMA-assisted psychotherapy as a legal treatment for PTSD.
3. Mithoefers to Lead MDMA-Assisted Psychotherapy Workshop at 25th Anniversary Conference
Lead study investigators and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., will conduct an all-day pre-conference workshop on Friday, December 9, as part of our 25th anniversary Cartographie Psychedelica conference and celebration. "The Principles of Psychedelic Therapy: Lessons from Clinical MDMA Research" will examine past and current research into psychedelic therapy, specifically focusing on recent findings from our ongoing MDMA-assisted psychotherapy research program.
4. DEA Approves US MDMA/PTSD Relapse Study Protocol
In early November, the official study initiation will take place for our new "relapse study" of MDMA-assisted psychotherapy for PTSD. Previously, on September 14, the Drug Enforcement Administration (DEA) notified MAPS that it had approved the Schedule 1 licenses required to transport, store, and administer the MDMA for the study. The FDA cleared the protocol on May 24 and an Institutional Review Board on June 9. With all necessary clearances, we will begin enrolling subjects in November.
This study, which will take place in Charleston, SC, is limited to up to three subjects whose PTSD symptoms returned years after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. It will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.
5. Israeli MDMA/PTSD Study Initiated
On October 12, 2011, the new Independent Rater in MAPS' Israeli study of MDMA-assisted psychotherapy for PTSD began working on the training videos that we have created to standardize how the Clinician-Administered PTSD Scale is administered across all of our treatment sites. This CAPS training is the last major element to complete before we can start enrolling and treating subjects. The official study initiation took place on July 24, when representatives from Antaea Medical Services, Ltd., the clinical research organization assisting MAPS with managing our Middle East studies, visited the site to finalize documents and provide training to the study staff. The study has all necessary clearances from Israeli regulatory bodies, including the Israeli Ministry of Health and an independent Ethics Committee. We have also submitted the protocol to the U.S. FDA, which is required because we are conducting the study under a U.S. Investigational New Drug application. The Israeli Defense Forces are already prepared to begin referring Israelis with chronic, treatment-resistant PTSD once we are ready to enroll subjects, probably before 2012.
6. Swiss MDMA/PTSD Study Final Report Submitted to SwissMedic
On October 14, 2011, MAPS' clinical research team submitted the final clinical study report for our recently completed Phase 2 Swiss study of MDMA-assisted psychotherapy for people with chronic, treatment-resistant PTSD to SwissMedic, the Swiss equivalent of the U.S. FDA. SwissMedic confirmed that the report had been received on October 18. The report, authored by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and MAPS Research and Information Specialist Ilsa Jerome, Ph.D., is required under International Council on Harmonization/Good Clinical Practice (ICH/GCP) and FDA regulations. The report contains information about the study protocol, information about the conduct of the study, and all study data in both raw and analyzed formats. The study team is now preparing the results for publication in a peer-reviewed academic journal.
A statistical analysis of the results reveals clinically significant decreases in scores on the Clinician-Administered PTSD Scale (CAPS), with an average reduction of 15.6 points. Due to the small number of subjects in this small pilot study, however, these decreases did not reach statistical significance. We did, however, observe trends toward statistical significance in both the CAPS and the Posttraumatic Diagnostic Scale (PDS), the two measures used to evaluate symptom severity in study subjects.
7. Health Canada Schedules Follow-Up Pharmacy Inspection for MDMA/PTSD Study
On October 18, 2011, Health Canada conducted a follow-up inspection of the pharmacy for our planned Phase 2 Canadian study of MDMA-assisted psychotherapy for PTSD. We expect that Health Canada will report on the results of this inspection within four to six weeks. Frustratingly, even though we followed Health Canada's exact written requirements, the requirements have now changed and additional security measures may be needed. This will delay the start of the study for several additional months. The pharmacy inspection is required under Canadian regulations to ensure that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. Once we obtain clearance from Health Canada we will be able to import the MDMA for the study into Canada from Switzerland.
The lead investigator for this study, Ingrid Pacey, M.D., will speak on the MDMA-Assisted Psychotherapy for PTSD Research Panel at our 25th anniversary conference this December.
More Research News
8. NIDA Rejects Marijuana Protocol, Blocking FDA-Approved Research for Vets with PTSD
On September 16, 2011, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five reviewers from the National Institute on Drug Abuse/Public Health Service had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. According to MAPS Executive Director Rick Doblin, Ph.D., the reviewers offered contradictory critiques, misunderstood key protocol design elements, requested expensive and tangential additions to the protocol, and made unfounded assumptions about the study design, revealing their focus on basic science research and lack of familiarity with drug development research. The reviewers also treated the submission as if MAPS were requesting a government grant for the study rather than using private funds. Even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.
For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS' detailed, point-by-point response to the HHS review, see the annotated reviewer comments.
Download MAPS' official press release announcing the HHS rejection.
9. Last Two-Month Follow-Up Completed in Swiss Study of LSD-Assisted Psychotherapy for End-of-Life Anxiety
By October 21, 2011, five out of 12 subjects have completed the long-term follow-up portion of our Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness. These long-term follow-ups take place at least 10 months following subjects' final treatment sessions. The last two-month follow-up visit was completed on July 26, 2011. This concludes the data collection portion of the first clinical LSD study in over 35 years. The results from the treatment period of the study are now being prepared for publication in a peer-reviewed scientific journal. The clinical team is now collecting long-term follow-up data in the form of additional interviews and psychiatric measures from subjects who have completed treatment, 10 or more months after their final treatment session. Five out of 12 subjects have now completed the long-term follow-up portion of the study. Once this data has been collected, the clinical team will prepare the final report for submission to SwissMedic and the U.S. FDA, and will submit the results for publication in a peer-reviewed scientific journal.
Principal Investigator Peter Gasser, M.D., will be giving a lecture and answering questions about LSD-assisted psychotherapy for end-of-life anxiety at our 25th anniversary conference this December.
10. Canadian Study Explores Ayahuasca-Assisted Therapy for Addiction and Dependence
On September 23, 2011, the final treatment session (consisting of a five-day therapeutic retreat) took place in MAPS Canada's observational study of ayahuasca-assisted therapy for individuals suffering from addiction and dependence. The research team has now recruited and is following up with 15 study subjects that have been treated. This study is taking place in British Columbia, and is overseen by MAPS Canada Board Member Philippe Lucas, M.A., with Principal Investigator Gerald Thomas, Ph.D., Rielle Capler, M.H.A., and Kenneth Tupper, Ph.D. Combining Western psychotherapeutic techniques with South American shamanic (Vegetalista) healing practices, this study is gathering preliminary evidence about the safety and effectiveness of ayahuasca-assisted therapy. Treatment consists of participation in a five-day retreat (facilitated by Gabor Maté, M.D.) including ayahuasca-assisted therapy, which may help reduce problematic substance use as well as addictions, compulsive behavior, and self-harming thought patterns. The study is being conducted in cooperation with a British Columbia First Nations band.
Philippe Lucas, M.A., will speak on ayahuasca research for addiction, and Lucas and Kenneth Tupper, Ph.D., will both participate in the all-day "Ayahuasca Healing: Medical, Legal, and Cultural Considerations" workshop at our 25th anniversary conference this December.
11. MAPS Hungary Publishes Report on European Ayahuasca Research Symposium
On October 15, 2011, the Multidisciplinary Association for Psychedelic Studies, Hungary (MAPS Hungary) completed a report on the European Ayahuasca Research Symposium (EARS), a half-day seminar co-sponsored by Stichting OPEN and MAPS which took place in April 2011 at the University of Amsterdam. Over 300 people were in attendance. The Symposium brought together researchers from across Europe who over the last few years have been studying ayahuasca and DMT within the disciplines of anthropology, neuroscience, psychology, and religious studies. The next morning, other European ayahuasca scholars joined presenters from the seminar for a closed-door researcher workgroup intended to stimulate future ayahuasca research and possible collaborations in Europe. The workgroup succeeded in building a shared knowledge base of ongoing and planned ayahuasca research, in facilitating discussions on methodology and obtaining institutional approvals for research, and in developing personal and professional contacts among the few ayahuasca researchers currently based in Europe. The short report shares some of the highlights of the workgroup.
12. Observational Study of Ibogaine Treatment for Addiction Enrolls Final Subject
The 30th and final subject was enrolled in our ongoing observational study of ibogaine treatment for addiction on August 29, 2011. This final subject has completed treatment at an independent ibogaine clinic in Mexico and will be evaluated for addiction and quality of life for 12 months. As of October 20, 2011, 28 subjects have completed their three-month follow-up interviews, and 20 have completed the six-month follow-up interviews. Given the increasing numbers of people around the world seeking ibogaine treatment for drug addiction, this study aims to gather evidence about the safety and effectiveness of the treatment and to compare different approaches to that treatment.
Thomas Kingsley Brown, Ph.D., the lead investigator for the study, will be speaking about the goals and progress of MAPS' ibogaine research program on Saturday, December 10 at Cartographie Psychedelica, our 25th anniversary conference in Oakland, CA.
13. Clinical Team Prepares Protocol for New Study of Ibogaine Treatment for Addiction in New Zealand
On October 17, 2011, the lead investigators for MAPS' ibogaine research program held a conference call to discuss the next steps for our new observational study of ibogaine treatment for addiction in New Zealand. Thomas Kingsley Brown, Ph.D., who leads our U.S.-based study of independent ibogaine clinics in Mexico, and Geoff Noller, Ph.D., who will lead the new study, shared perspectives and lessons from ibogaine therapy research in order to guide the development of the new study protocol. The new study will take place at an independent ibogaine clinic in New Zealand, and will examine the safety and long-term effectiveness of ibogaine treatment for addiction severity and quality of life in 20 to 30 patients. The clinical team will submit the protocol and other documents to the Ethics Committee by the end of October.
Since this will be an observational study (as opposed to clinical) the protocol does not need to pass through an additional review process, meaning that we can begin enrolling subjects as soon as the study clears the Ethics Committee. Data from this study and our ongoing study of Mexican ibogaine treatment centers may be used to make a case for a possible future clinical study (see our original ibogaine Request for Proposals).
14. Autism Protocol Development: MAPS Releases Request for Proposals (RFP)
MAPS is offering a grant of $10,000 for protocol development expenses for a pilot study of MDMA for the treatment of high-functioning autism or Asperger's syndrome. We have prepared a Request for Proposals (RFP) for U.S.-based researchers. One of the factors that we'll look for in selecting a research team is whether they would also have a chance of obtaining funds for research from other grant agencies (autism research is currently a well-funded field). At present, we do not have the funds for the study itself but we do have funds for protocol development. Once we have a completed protocol, we can develop a budget and a fundraising plan. MAPS itself would be in a much better position to raise funds for a study with a completed protocol from a qualified research team.
15. Cartographie Psychedelica: December 8-12, Oakland, CA
16. International Drug Policy Reform Conference: November 2-5, Los Angeles, CA
17. Spirituality & Psychology Conference: February 17-19, 2012, Atherton, CA
18. Washington Post Makes Federal Marijuana Research Blockade National News
On October 1, 2011, the Washington Post continued the trend of positive media coverage with an exposé about the federal government's refusal to sell us marijuana for the planned study ("Marijuana study of traumatized vets stuck in regulatory limbo", October 1, 2011). See MAPS' http://www.maps.org/mmj/MAPS_HHS_rejection_PR_FINAL.pdf">official press release for more about the federal obstruction of medical marijuana research, and learn why MAPS is taking the DEA to federal court.
The exposé was followed two weeks later by a persuasive Washington Post op-ed condemning the federal government's ongoing refusal to allow legitimate, necessary medical marijuana research from moving forward ("Marijuana may help PTSD. Why won't the government find out for sure?" October 14, 2011).
Steve Fox of the Marijuana Policy Project writes: "It is time for government officials to take this nation's veterans off the medical marijuana battlefield. NIDA should grant the researchers' request to purchase marijuana and allow the FDA-approved study of veterans to move forward. These brave men and women don't have decades to wait for relief."
19. Public Support Builds for MAPS' International Psychedelic Research
On September 30, 2011, The Guardian reported on a possible new MAPS-sponsored study of MDMA-assisted psychotherapy for PTSD to take place in the UK ("Ecstasy trial planned to test benefits for trauma victims", September 30, 2011). MAPS, together with psychopharmacologist Dr. David Nutt and psychiatrist Dr. Ben Sessa, are considering submitting a grant proposal to a major UK foundation for the study. If it receives funding and regulatory approval, the study would be the first of its kind in the UK. The article concludes with Dr. Nutt's observation that more cautious UK media such as The Daily Mail would not welcome the news, a recent positive article in that same publication clearly shows that times are changing. As The Guardian article points out, MAPS' research on MDMA-assisted psychotherapy for PTSD "has caused some in the scientific community to think what was until recently unthinkable."
Additional coverage of MAPS' possible UK study of MDMA-assisted psychotherapy for PTSD also appeared in The Herald Sun, the Sydney Morning Herald, the Hindustan Times, and The Times of India.
A long and in-depth article on Salon.com also shed light on the wide-open field of medical psychedelic research, focusing primarily on recent and ongoing studies at NYU and Johns Hopkins. You may also remember that last year, the influential medical journal The Lancet Oncology noted that the growing support for psychedelic and (in public opinion if not government policy) medical cannabis research is part of a larger pattern involving "the increased willingness of researchers and regulatory bodies to look beyond stigma, and take a more rational approach to the controlled medical use of compounds that are more often linked with the war on drugs."
For more snapshots of how MAPS is helping change how the world sees psychedelics and medical marijuana, visit MAPS in the Media.
20. Mind Body Health & Politics Radio Show Hosts Psychedelic Medicine Series
"Mind Body Health & Politics" with Dr. Richard Miller is hosting a series on Psychedelic Medicine, featuring personal interviews with scientists and thinkers in psychedelic and medical marijuana research. "Mind Body Health & Politics" airs the first and third Tuesday of the month at 9 AM on National Public Radio affiliate KZYX FM (Mendocino County Public Radio). You can also listen live online at mindbodyhealthpolitics.org.
- Psychedelic Medicine I: Ethnobotany with Dennis McKenna
Broadcasted September 20, 2011 (mp3).
- Psychedelic Medicine II: The Historic MDMA study
Dr. Miller and MAPS researchers Michael Mithoefer, M.D., and Ann Mithoefer, B.S.N., discuss their FDA-approved clinical trials of 3,4-methylenedioxymethamphetamine (MDMA) as a therapeutic tool to assist psychotherapy for the treatment of posttraumatic stress disorder (PTSD). Broadcasted October 4, 2011 (mp3).
- Psychedelic Medicine III: The Psychedelic Explorer's Guide
Jim Fadiman, Ph.D. discusses his new book The Psychedelic Explorer's Guide: Safe, Therapeutic and Sacred Journeys (available in the MAPS Store). Broadcasted October 18th, 2011 (mp3).
The mission of "Mind Body Health and Politics" is to enhance health, provoke thought, expand consciousness, and encourage mental health.
- November 1: Mark Blumenthal , Ph.D., founder and executive director of the American Botanical Council.
- November 15: Dave Nichols, Ph.D., pharmacologist, medicinal chemist, founding president of the Heffter Research Institute, and one of the world's leading experts on psychedelics.
- November 29: Charles Grob, M.D., psychiatrist, psilocybin researcher, and conductor of the first government-approved study of MDMA in humans.
21. DMT: The Spirit Molecule Now Available on Video
The highly anticipated documentary DMT: The Spirit Molecule was released on October 1, 2011 through Warner Bros. and Gravitas Ventures. The film explores psychedelic ecology, the cultural history of psychedelics, shamanism and ayahuasca, psychedelic research, the effects of psychedelics, spirituality, consciousness, and much more. By remixing current research, thoughts, and theories about psychedelic tools the film helps create a new paradigm for consciousness.
To support the release, the filmmakers created the DMTrmx Project, which utilizes the entire media library (over 100 hours of interviews, 30 hours of footage from the Peruvian Amazon, one hour of VFX, original music, and sound files). Their goal is to enhance the cultural dialogue about psychedelic research by offering the content via a non-commercial Creative Commons license, and making it available for viewing and/or downloading from YouTube and a soon-to-be-launched standalone site (http://www.DMTrmx.com).
Check out this amazing film, and share it with friends, colleagues, and family members. Both the documentary and the DMTrmx Project aim to have a positive influence on the psychedelic narrative. The film can be seen on iTunes, and a variety of other platforms.
22. Dirty Pictures Documentary Looks at the Genesis of MDMA
A festival hit since its world premiere at the 2010 SXSW Film Festival, Dirty Pictures is a look inside the creation of psychedelics and the mind that made it all possible. Alexander "Sasha" Shulgin is the scientist behind more than 200 psychedelic compounds—including MDMA. Considered to be one of the greatest chemists of the 20th century, Dr. Shulgin's vast array of discoveries have had a profound impact in the field of psychedelic research, making him a subject of fascination and controversy among fellow scientists and a folk hero to recreational users of psychedelics.
23.Yarindin Documentary Explores Trauma, Combat, and Psychedelic Healing
Yarindin is a feature-length documentary of combat, love, and the healing journey. It will capture the drama of a band of brothers and sisters who fought together on the fields of battle and now fight to heal together in the fields of the soul, blessed by the beauty of nature and the healing magic of indigenous medicine. Yarindin is the story of a group of veterans ravaged by war who journey to South America for initiation into the indigenous plant medicine of the Amazon. To manifest his vision, ayahuasquero and sound healer Dr. Richard Grossman teamed up with award-winning filmmaker Mark Schwartz. They are currently raising funds for recruiting six to eight traumatized veterans, bringing them to the jungle of Peru for three weeks of ceremonies in late spring of 2012, and documenting the process before, during, and after their journey. The hope is to tell a story so compelling it will touch hearts and minds on a wide scale. Watch the video demo and discover more about this film.
24. MAPS Celebrates Recent Fundraising Successes
The Multidisciplinary Association for Psychedelic Studies would like to publicly thank all of those who continue to support us in our ongoing work. As psychedelic research expands and more opportunities emerge for medical marijuana, acquiring the financial resources to conduct our work becomes more important than ever. Whether you've purchased a book from the store, signed up for a monthly membership, attended a MAPS event, or made a one-time contribution, we—and the countless people who could benefit from these medicines—sincerely thank you.
We especially want to highlight the courage and commitment of the following individuals and foundations:
If you would like to help MAPS develop safe and legal contexts for the therapeutic use of psychedelics and marijuana, please make a donation. Visit our Funding Priorities page to learn more about our specific projects and how your gift will be used.
- Joseph Kolb for personally contributing $1,000, of which $500 was matched by his employer Xinet for a combined total of $1500.
- Gerald Gaines and the Compassion First Caregiver Circle of Phoenix, AZ, for a $10,000 grant for our continued work on the protocol review and approval process for our planned study of marijuana for 50 veterans with PTSD.
- Matt and Kristi Bowden of Stargate International for a $25,000 donation for our upcoming "intern study" of MDMA-assisted psychotherapy for PTSD.
- Riverstyx Foundation for $50,000 of unrestricted funds for MAPS' research and educational projects.
- The Mental Insight Foundation for $60,000 to be used for our ongoing study of MDMA-assisted psychotherapy for PTSD in U.S. veterans.
- Adam Wiggins for $100,000 of unrestricted funds for MAPS' research and educational projects.
New in the MAPS Store
25. The Psychedelic Journey of Marlene Dobkin de Rios: 45 Years with Shamans, Ayahuasqueros, and Ethnobotanists
This book is a look inside almost half a century of pioneering research in the Amazon and Peru by a noted anthropologist of ayahuasca and other psychedelics. Marlene Dobkin de Rios reveals how ayahuasca can be used to successfully treat psychological and emotional disorders through a cross-cultural examination of adolescent drug use and a discussion of the harmful effects of drug tourism in the Amazon. Although late Harvard ethnobotanist Richard Evans Schultes was credited in the early 1950s as being the first to document the use of ayahuasca, other researchers, including Dobkin de Rios, were responsible for furthering his findings and uncovering the curative capabilities of this fascinating compound. The Psychedelic Journey of Marlene Dobkin de Rios presents the accumulated experience of the author's 45 years of pioneering field studies in the area of psychedelics in Peru and the Amazon. All proceeds help fund MAPS' psychedelic and medical marijuana research and education.
26. The Psilocybin Solution: The Role of Sacred Mushrooms in the Quest for Meaning
In The Psilocybin Solution, Simon G. Powell traces the history of the psilocybin mushroom and discusses the shamanic visionary effects it can induce. Detailing how psilocybin acts as a profound enhancer of consciousness and reviewing the research performed by MAPS, Johns Hopkins University, and the Heffter Research Institute on psilocybin's beneficial effects on anxiety in the terminally ill and obsessive-compulsive disorder, Powell examines the neurochemistry, psychology, and spirituality underlying the psilocybin experience, revealing the interface where physical brain and conscious mind meet. All proceeds help fund MAPS' psychedelic and medical marijuana research and education.
27. Donate an Item to MAPS' 25th Anniversary Adventure Auction
28. International Ayahuasca Researchers to Meet at Cartographie Psychedelica
29. A Deck of Medicine: Stormrider Calling Cards by Requa Tolbert
Medicine artist Requa Tolbert, with the support of the Women’s Visionary Council, has published her deck of medicine cards. The deck was first assembled in 1995 for a Day of the Dead shrine, after years of pioneering research with husband George Greer, M.D., on the therapeutic and spiritual uses of MDMA and ketamine. Having suffered from health problems for a year, the production of the cards have had a profound influence on Requa’s healing process, as she used the images and poetry they contain to come to a deeper understanding the healing power of these ancient substances, used for millennia in shamanic contexts. A book of essays that further addresses the lore, natural history, and imagery of each card is also available online.