MDMA Research News
1. Therapists Trained for Israeli MDMA/PTSD Study; Revised Protocol Prepared for Ministry of Health
From January 23-27, 2011, MAPS Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., conducted a training course for therapists who will be conducting the treatment sessions in MAPS' new Israeli study of MDMA-assisted psychotherapy for PTSD. The training took place over five days, with the first three days in Tel Aviv in the basement of a house built by Rick Doblin's great-grandfather in 1923. The therapists reviewed MAPS' treatment manual of MDMA-assisted psychotherapy for PTSD and were familiarized with the study protocol. As part of the training, they also studied several videos of actual treatment sessions from our completed U.S. MDMA/PTSD study.
The last two days of the program took place at Be'er Ya'akov Mental Health Center outside Tel Aviv. During their visit, the study team met with hospital administrators, who have agreed to provide us with a dedicated area in a standalone building separate from the main facility for conducting the clinical sessions, including a separate bathroom and kitchen. Although the hospital itself dates back to the 1940s, it is currently undergoing several renovations and improvements. The grounds include orange groves and walking paths, and we are excited to have access to such a secure and comfortable site for conducting the sessions.
Building on our experience with our previous Israeli study, MAPS has determined that pairing traditionally trained psychiatrists with others with more direct experience working with altered states of consciousness is likely to produce a more effective therapeutic team. After this last meeting, the clinical team has decided to use three (rather than two) male/female co-therapist teams in order to increase enrollment rates and to provide more opportunities for therapists to learn from each other. The variety of expertise brought to the therapeutic sessions by these co-therapist teams should make them more effective at achieving positive treatment outcomes.
During the visit, the clinical team also fine-tuned the study protocol by adding the third co-therapist team, a secondary self-report measure of PTSD symptoms, and a measure of sleep quality. Although the original protocol was already approved by the Israeli Institutional Review Board (IRB), the revisions required us to resubmit it to the IRB. These revisions have been submitted to the IRB by the end of this week, which will review the protocol and forward it to the Israeli Ministry of Health (the Israeli equivalent of the U.S. FDA) for final approval. On April 6, the Ministry of Health will meet to discuss the protocol and inform MAPS about whether the study may proceed. Since we have already imported the MDMA from Switzerland into Israel for the previous study, getting the go-ahead from the Ministry of the Health will be the last step before we can initiate the new study.
2. Jordanian MDMA/PTSD Clinical Team Meets; Study Awaits Final Approval
On January 30, 2011, MAPS Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., led a one-day course for the therapists who will conduct the treatment sessions in our upcoming Jordanian study of MDMA-assisted psychotherapy for PTSD. Although the Jordanian therapists were trained in using our MDMA-assisted psychotherapy treatment manual prior to our April 2010 conference, the manual has since then undergone several revisions to its adherence criteria. The course gave them the opportunity to learn the new criteria and ask questions about their implementation.
The visit to Jordan was also a chance to gather the clinical team together in preparation for initiating the study once the Jordanian FDA has decided on insurance requirements for subjects enrolled in the study. These insurance requirements are necessary should subjects experience any negative effects as a result of study participation, a necessary legal precaution even though over 480 subjects have taken MDMA in clinical or laboratory research settings to date without evidence of a single drug-related Serious Adverse Event. Since this study will be the first psychedelic research in Jordan, the first time a non-profit drug developer has requested permission to conduct a study in the country, and the first time researchers have sought to use a drug administered just a few times as part of the therapeutic process, regulators in the country must develop a brand new set of research requirements. Once the Jordanian FDA has informed us about these requirements and approved the study, and we have obtained a permit to import the MDMA from Switzerland, we will be able to begin recruitment for the study.
On January 31, 2011, the Jordanian clinical team held an Investigators' Meeting during which the lead investigators, therapists, and representatives from Antaea Medical Services (the clinical research organization hired by MAPS to monitor both our Israeli and Jordanian studies) discussed the process for initiating and conducting the study once it has cleared the Jordanian FDA review. Antaea will be responsible for monitoring the quality of the data gathered during the study, ensuring therapists' compliance with the protocol, and ensuring that all the paperwork is in order in case the U.S. or Jordanian FDA decides to audit the study. The meeting included a welcome by MAPS Founder and Executive Director Rick Doblin, Ph.D., and Antaea CEO and Managing Director J.R. Roussos; a presentation by Dr. Mithoefer on the pharmacology and safety profile of MDMA; a presentation by MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., on the study protocol itself; and another by Antaea's Kamila Novak on investigator responsibilities.
3. Final Closeout Takes Place for Swiss MDMA/PTSD Study
From February 13-16, 2011, MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., visited Switzerland for the official closeout of our Swiss study of MDMA-assisted psychotherapy for PTSD with lead researcher Peter Oehen, M.D. This visit included cleaning up data, reviewing the investigator's files, collecting originals of essential documents and recordings, reviewing source records and case report forms, and preparing all materials for archiving. Some of the treatment session recordings from the Swiss study will also be used to compare and contrast the treatment methods of U.S. and Swiss therapists, since professional and cultural differences can lead to differences in approaches to treatment. One of MAPS' goals is to create a manualized treatment methodology that can be applied internationally, making comparisons especially important.
4. New Harvard Study Shows No Link Between Ecstasy and Cognitive Damage
On February 15, 2011, the journal Addiction published online the results of a neuroscience study finding no evidence of impaired cognitive performance in users of Ecstasy, the street name for the chemical known as MDMA. The study, conducted by researchers at Harvard-affiliated McLean Hospital and led by Dr. John H. Halpern, improves on earlier studies in several ways. It used subjects who used few or no other drugs or alcohol, compared those subjects to others from the same all-night dance community who had not used Ecstasy, performed complete psychiatric assessments, and utilized hair analysis and other drug testing procedures. Since previous studies of the neurocognitive effects of Ecstasy did not address these issues, their reports of damage to memory, strategic planning, and other cognitive tasks may have been due to confounded study design rather than to Ecstasy itself.
The results do not mean that Ecstasy use is always safe—to the contrary, there are a number of other risks associated with recreational Ecstasy use (such as the unknowable contents of illegally-acquired Ecstasy tablets and capsules and the potential for dehydration and exhaustion at all-night dance parties), and these risks need to be taken into consideration when individuals choose to use the drug. The research suggests, however, that these risks are unlikely to be due to the drug itself.
The study was funded for five years by the National Institute on Drug Abuse (NIDA) and was based on pilot data collected with the assistance of MAPS. The concept for the research was suggested by MAPS member Ben Stokes, Ph.D., a postdoctoral astrophysicist at the University of Utah. Stokes wrote to MAPS concerned that the absence of subjects who had taken Ecstasy but not other drugs was a critical methodological flaw in studies of the effects of Ecstasy on neurocognition. Stokes proposed that MAPS conduct a pilot study in a Utah population whose drug use had been almost exclusively limited to Ecstasy.
MAPS achieved an impressive leveraging of funds for the research, transforming its own initial contribution of $15,000 for the pilot study into a $1.8 million grant from NIDA independently awarded to the research team at McLean Hospital. This effective use of resources to catalyze methodologically rigorous research confirms our position as a leader in the investigation of the risks and benefits of MDMA.
Among the media commenting on the study's results was the UK National Health Service (NHS). While the NHS rightly acknowledges that "this research cannot confirm that Ecstasy is a safe drug," it also makes some glaring errors in its conclusions about the study's significance. Dr. Halpern has responded to these errors in a post on the MAPS website.
The study also received attention from a number of other media outlets, including The Guardian (UK), Reason Magazine, the India Times, and New Scientist. MAPS also sent out a press release which was picked up by over 80 media sources.
Other Research News
5. MAPS Addresses FDA Concerns about Planned Marijuana/PTSD Study
On February 3, 2011, the U.S. FDA asked MAPS to provide additional information regarding the protocol for our planned study of the safety and effectiveness of smoked and/or vaporized marijuana for the treatment of PTSD symptoms in war veterans. The agency's principal concerns involved the possibility of subjects giving or selling ("diverting") unused marijuana during or after the study. This is an important point for the FDA given that this study would be the first outpatient marijuana study to be conducted in approximately 30 years.
On February 9, 2011, MAPS and the FDA had a teleconference to discuss these concerns. It was a major success. Prior to the meeting, MAPS prepared responses to each of the seven points raised in the February 3 letter and developed a chart listing of the advantages and disadvantages of several strategies for preventing diversion. We proposed a two-part solution: First, each subject will be given a handheld video camera (the Flip) with which they will record themselves removing the marijuana from its canister (containing one week's supply), using it, and replacing unused material. Study staff will review these videos on a weekly basis prior to giving subjects their next week's marijuana. Second, subjects will be asked to give us the name of a significant other who we can call weekly for independent verification that subjects used the marijuana themselves. If it cannot be verified that subjects used the marijuana themselves, they will be removed from the study.
During the teleconference, the FDA said our approach was reasonable. They indicated that we should submit the revised version incorporating the new safeguards for FDA review. The FDA saw that we were sincere in trying to address the issue of diversion control, and we saw that the FDA was willing to move forward with our study. However, if the FDA approves the protocol, we still need to run the gauntlet of the redundant Public Health Service/National Institute on Drug Abuse review process, which is likely to be much more difficult and much less reasonable than that of the FDA. At the very least, we are one crucial step closer.
6. Scientist Files Final Brief in 10-Year Fight with DEA to Grow Marijuana for Research
For nearly a decade, MAPS has been challenging the federal government's monopoly on marijuana for research by supporting one scientist's efforts to start his own marijuana farm. On March 7, that scientist and his lawyers at the American Civil Liberties Union and Washington, D.C., law firm Jenner & Block submitted their final brief in their marathon lawsuit against the Drug Enforcement Administration.
Right now, a lab at the University of Mississippi is the only facility in the U.S. with a license to grow marijuana for research. Any scientist who proposes a study of marijuana must purchase it from this lab, whether they're interested in its risks or in its medical uses. Unfortunately, the National Institute on Drug Abuse—which funds the lab and therefore decides which studies get marijuana and which do not—only supports research into the potential harms of marijuana. That makes it practically impossible to do the research with the greatest potential for helping actual patients.
The only way to change the situation is to end NIDA's monopoly, which is exactly what MAPS and Professor Lyle Craker, Director of the Medicinal Plant Program at the University of Massachusetts-Amherst, have been trying to do for nearly ten years. We're expecting the FDA to allow us to proceed with our proposed study of the safety and effectiveness of smoked and/or vaporized marijuana for PTSD in war veterans, and NIDA (and its parent agency the Public Health Service) are the only ones standing in its way.
Read the MAPS press release announcing the latest developments in the case.
7. Swiss LSD Study in Final Stages
From February 17-19, 2011, in yet another stop on her whirlwind international tour, MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., met with Clinical Investigator Peter Gasser, M.D., in Switzerland to monitor the progress of our Swiss study of LSD-assisted psychotherapy for end-of-life anxiety. The study has completed recruitment, with 11 of 12 subjects having received LSD-assisted psychotherapy with either a full dose or a low dose of LSD. Preliminary data has been collected for an interim analysis. During her visit, Yazar-Klosinski also trained Christina Blank, a new study coordinator who will be conducting follow-up interviews with subjects in the Swiss LSD study. Blank previously worked with as a research associate with psychedelic researcher Franz Vollenweider, M.D. Subjects will be interviewed for at least 10 months after their final treatment session in order to gather qualitative and quantitative data about their anxiety symptoms and health. Results from the follow-up extension study will be compared with the quantitative data gathered during the treatment phase of the study.
8. Long-Term Ibogaine Treatment for Addiction Outcome Study Progresses
As of March 1, 2011, MAPS' observational study of the long-term efficacy of ibogaine-assisted therapy for drug addiction has enrolled 16 out of 30 subjects. All participants in this study have already received ibogaine-assisted therapy at one of two independent treatment centers in Mexico, and the study is an attempt to evaluate the quality and duration of their treatment outcomes. The rationale for this study is based on the increasing numbers of people turning to ibogaine and ibogaine-assisted therapy for addiction treatment despite its high level of risk and little scientific knowledge about its long-term effectiveness. Over the course of the study, MAPS researchers use the Addiction Severity Index (ASI) to evaluate patterns of drug use including addictive behavior and overall quality of life. We are also using the States of Consciousness Questionnaire (SOCQ) to determine whether there is a correlation between the depth or intensity of the ibogaine experience and the duration of its therapeutic effects. The study also involves random drug testing of subjects to correlate data from the ASI with the results. A database is also currently under construction for managing and analyzing study data.
9. Beckley Foundation Psilocybin/fMRI Study Progresses
As of January 31, 2011, 13 of 15 total subjects have been scanned in the Beckley Foundation's ongoing study using functional magnetic resonance imaging (fMRI) to examine the effects of psilocybin on the brain activity of healthy volunteers. So far, 6 subjects have received psilocybin and 7 have received placebo. The study, led by Robin Carhart-Harris, Ph.D., in collaboration with Richard Wise, David Nutt, Ph.D., and Amanda Feilding, aims to discover whether psilocybin improves subjects' memory of significant events from their own lives. The Beckley Foundation is a UK-based organization that funds and encourages scientific investigations of consciousness and altered states. Both MAPS and the Heffter Research Institute have contributed $10,000 for the study to help cover some of the costs, with the Beckley Foundation covering most of the costs.
10. Researcher Seeks Psychiatrists' Response to Survey
Robin Carhart-Harris, Ph.D., a psychedelic researcher in the Neuropsychopharmacology Unit at Imperial College London, is currently running a study requiring psychiatrists' responses to a survey. Take the survey today to contribute to this new research!
11. MAPS Nearing $15,000 Goal in Watch, Learn, & Share Video Campaign
Thanks to the enthusiasm and support of MAPS supporters worldwide, our videos from "Psychedelic Science in the 21st Century" have logged nearly 13,000 views! An extremely generous MAPS donor's pledge to donate $1 every time a video is watched has enabled you to help us raise almost $13,000—just by watching videos on psychedelic science, art, and culture. We aren't far away from logging 15,000 views for $15,000. Help us reach our goal by watching a video today!
12. Buy Your Tickets Now for MAPS' 25th Anniversary Texas Tour This Week
Starting tonight, from March 9-11, 2011, MAPS will be visiting the state of Texas for the first time since 2007 to re-connect with local supporters, meet for dinner and discussion, and celebrate our upcoming 25th anniversary. MAPS Founder and Executive Director Rick Doblin, Ph.D., will be in attendance each evening to discuss the past and future of psychedelic psychotherapy research and education. Each evening will be an intimate gathering at the elegant home of a local MAPS supporter, and will feature fine food followed by brief presentations by MAPS staff and local colleagues. We will also be featuring a small selection of works by Martina Hoffmann, A. Andrew Gonzalez, and other artists, with proceeds from sales to benefit MAPS. The minimum suggested donation for each event is $100, with all proceeds going to support our research fund for MDMA-assisted psychotherapy for PTSD. It's not too late to purchase your ticket!
13. Rick Doblin to Speak at UK Psychedelics Conference in April
On April 2-3, 2011, the University of Kent at Canterbury in association with the Beckley Foundation will be hosting "Breaking Convention: A Multidisciplinary Conference on Psychedelic Consciousness." The two-day conference, of which MAPS is an affiliate, will feature workshops, seminars, and presentations on research into psychedelics and consciousness. The four main symposia will address the cultural role played by psychedelics; current scientific investigations into psychedelics; the future of psychedelic research; and the place of MDMA and Ecstasy in society, medicine, and politics. MAPS Executive Director Rick Doblin, Ph.D., will be speaking and participating in workshops on the history and future of MDMA research. MAPS MDMA researcher Peter Oehen, M.D, will also be in attendance. See the conference website for more information.
14. New Charles Shaw Drug War Documentary to Premier in SF, LA, Chicago
On March 31 and April 1, 2011, journalist and activist Charles Shaw will be premiering his newest film project about the personal tragedies and social injustices caused by the failed war on drugs. The Exile Nation Project: An Oral History of the War on the Drugs and the American Criminal Justice System is a collection of testimonials from criminal offenders, their family members, and experts on the criminal justice system, and puts a human face on the real costs of the war on drugs. The film will premier on Thursday, March 31 in San Francisco and http://exilenationhollywood.eventbrite.com/" target="_blank">Friday, April 1 in Los Angeles. There will also be a screening on April 2 in Chicago, but details are still to be announced.
15. O Magazine Helps Move MDMA Therapy into the Mainstream
On February 15, 2011, Oprah Winfrey's O Magazine published a magnificent cover article on MDMA-assisted psychotherapy, perhaps the most significant and widely read media coverage MAPS has received in years. In a thoroughly researched and well-balanced portrait, Sarah, who suffered from PTSD for 20 years as the result of severe childhood trauma, gives us a brutally honest look at her experience as a patient in MAPS' groundbreaking study of MDMA-assisted psychotherapy for PTSD. Jessica Winter, the author of the article, also gives us a first-hand account of her own experience of MDMA therapy. To see MDMA-assisted psychotherapy discussed so honestly and personally in such a prominent media source is to be reminded of the ever-broadening mainstream acceptance of psychedelics as medicines.
In a short interview complementing the main article, journalist Jessica Winter talks about her experience doing the research for her for O feature article. She cites a 2006 Boston Globe article about Marilyn Howell's (referred to in the 2006 article as "Diane") experience with MDMA-assisted therapy for her dying daughter as the inspiration for her research. Keep an eye out for Howell's gripping new book Honor Thy Daughter about her and her daughter's experience, to be published by MAPS in April 2011.
16. MAPS Hits the Headlines
It's getting hard to keep track of all the media attention MAPS has been receiving lately. Between our last email newsletter and March 1, 2011, MAPS' MDMA/PTSD research has been featured in over 20 individual news stories around the world. These include O Magazine, The Huffington Post, German news show Odysso, German magazine Basler Zeitung, the Santa Cruz Sentinel, the San Jose Mercury News, Reason Magazine, The Guardian (UK), the Miami New Times, the India Times, Fox 5 News Atlanta, the UK National Health Service's Choices, New Scientist, and more. That's not including the over 80 media outlets that picked up MAPS' press release announcing the results of Dr. John Halpern's new NIDA-funded Harvard study of the risks of recreational Ecstasy use. MAPS funded Dr. Halpern's pilot study. As if that weren't enough, we have also been contacted by major television producers from CBS Evening News, BBC, Canadian national current events show Global TV, and others. See the MAPS in the Media section of our website for summaries and full text as well as links to the original stories.
17. Now on Sale in the MAPS Store: Psychedelic Healing by Neal M. Goldsmith, Ph.D.
Is there a connection between science and spirituality? How are some of the world's most prestigious scientists transforming the politics of psychopharmacology? If you're curious about these questions—or if you think you already know the answers—then the latest book by psychotherapist Neal M. Goldsmith, Ph.D., definitely belongs on your bookshelf.
Psychedelic Healing: The Promise of Entheogens for Psychotherapy and Spiritual Development is a biography of psychedelic medicine, taking you from its shamanic youth through its adolescent troubles with the law and into its current blossoming as a healthy and responsible member of mainstream society. According to MAPS Founder and Executive Director Rick Doblin, Ph.D., Psychedelic Healing represents "a major contribution to…the continued expansion of the psychedelic research renaissance." Drug Policy Alliance Executive Director Ethan Nadelmann, J.D., Ph.D., calls it "a brave and wonderful book," and ethnopharmacologist Dennis McKenna refers to Goldsmith as "one of the leading architects of the emerging paradigm of psychedelic therapy."
In a clear summary of cutting-edge clinical research, Goldsmith explains how the medical community has found psychedelics to be a crucial part of therapies that ease anxiety in the dying, loosen the grip of addictive drugs, relieve posttraumatic stress disorder, and help people overcome profound pain and suffering. He also tells of his own experiences using psychedelics as healing tools, and offers guidelines for working with them in psychotherapy. Psychedelic Healing is a true story about the past, present, and future of psychedelics as therapeutic tools.
By purchasing Psychedelic Healing directly from MAPS, you will be an essential part of that story. All proceeds from sales through the MAPS store will go directly to funding MAPS' groundbreaking work to make psychedelic healing available to those who need it most.
18. Coming Soon from MAPS Press: Honor Thy Daughter by Marilyn Howell, Ed.D.
Keep an eye out in early April for the newest book from the MAPS press. Honor Thy Daughter is an intimate true story by Marilyn Howell, Ed.D., about her family's search for physical, emotional, and spiritual healing as her daughter struggles with terminal cancer. The family's journey takes them through the darkest corners of corporate medicine, the jungles of Brazil, the pallid hallways of countless hospitals, and ultimately into the hands of an anonymous therapist who offers the family hope and healing through MDMA-assisted psychotherapy. The story was originally featured in a 2006 Boston Globe article in which Howell's identity was concealed. With psychedelic medicine increasingly a part of the mainstream vocabulary, in Honor Thy Daughter Howell comes out of the closet and shares with us how psychedelic therapy helped heal the bonds ripped apart by illness. An excerpt from the book will appear in the next edition of the MAPS Bulletin.
19. MAPS Welcomes Brian Brown as New Development Associate
MAPS is immensely pleased to announce the arrival of Brian Brown as the new MAPS Development Associate. Brian studied Medical Anthropology and Visual Culture at the University of California, Santa Cruz where he researched the social prospects for psychedelics using a community-centered approach. Undergraduate fieldwork investigating the creative, recreational, spiritual, and medicinal uses for psychoactive compounds quickly led Brian to MAPS. He is now developing MAPS' membership base by assisting with education and outreach efforts. Before joining MAPS, Brian worked extensively as an intellectual property consultant and event organizer, and believes in a self-directed path of psychological and spiritual development. By combining his family history in psychology, his education in social investigation, and his personal love for community, people, and art, Brian's broad range of talents are well-suited to generating wider public interest in the endeavors of MAPS.
20. New Documentary on Secret History of LSD Needs Your Help
A brand new documentary by Connie Littlefield on the history of underground psychedelic chemistry needs your help. Better Living Through Chemistry features in-depth and personal interviews with early LSD manufacturers Nicholas Sand and Tim Scully, whose commitment to making and distributing "the finest, purest LSD ever created" eventually brought them face to face with the law. The film promises to throw the doors wide open on the (until now) secret history of psychedelics and the war on drugs. $15,000 is required to begin production and early publicity efforts—of which nearly $6,000 has already been raised—all of which must be raised by March 21, 2011. Help make sure this film sees the light of day!
21. Psychedelic Healing Documentary Wants Your Story
22. New Film on Ayahuasca Shamanism by Rak Razam Seeks Funding
AYA: Awakenings is an audiovisual journey into the world and visions of ayahuasca shamanism, and needs your financial support for completion. Produced by the Undergrowth collective and adapted from the book Aya: A Shamanic Odyssey by Rak Razam (editor of The Journeybook), AYA: Awakenings is a "video book" merging narration gleaned from select chapters of the book with interviews and innovative sound design. It takes viewers on a journey into the jungles of Peru, where the practice of traditional shamanism has an unbroken lineage to the present day. The documentary uses interviews with practicing curanderos and incorporates traditional icaros ("magic songs"), photographs, and video recorded in Peru, with traditional patterns to reproduce the visions seen in the ayahuasca trance. Please contribute now to directly fund cutting-edge animation, video editing, sound design, artwork, and operating costs for completing the film and releasing it to the public.
23. Can MDMA Help Relieve Stuttering?