1. Legal Team Submits Opening Brief in Federal Lawsuit Against the DEA
On December 15, 2011, the legal team representing Prof. Lyle Craker on a pro-bono basis filed their opening brief in the First Circuit Court of Appeals in our much-anticipated lawsuit against the Drug Enforcement Administration to grow marijuana for research. Prof. Craker is suing the DEA for rejecting a DEA Administrative Law Judge's 2007 recommendation that it would be in the public interest for Prof. Craker to be granted a license to cultivate marijuana under contract to MAPS exclusively for federally regulated medical research.
The 232-page document (PDF) represents the combined efforts of Prof. Craker, Washington, D.C. law firm Covington & Burling LLP, the American Civil Liberties Union, and MAPS. The brief is a major challenge to the DEA's politically motivated decision to uphold the federal monopoly on marijuana for research. The brief highlights the DEA's arbitrary standard for rejecting the DEA judge's recommendation, and documents the agency's use of an opposite standard in other cases, showing a clear bias in the DEA's efforts to block privately-funded medical marijuana production. The DEA has received an extension until February 24 to file their brief.
2. US Veterans MDMA/PTSD Study Screens Eighth Subject
On December 1, 2011, the eighth (out of 16) veteran passed in-person screening for participation in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with PTSD. Five subjects have now been enrolled and treated, and have entered the long-term follow-up portion of the study, which will last twelve months following their final experimental treatment session. As of January 9, our clinical team had received 172 inquiries about participation in the study, emphasizing the widespread need among veterans for more effective treatments for PTSD resulting from military service. We are now seeking an additional $250,000 to expand this study from 16 subjects to 24.
3. MDMA-Assisted Psychotherapy Relapse Study Initiation Takes Place in January
On January 16, 2012, the official study initiation will take place for our upcoming relapse study of MDMA-assisted psychotherapy for PTSD. The first subject will be enrolled shortly thereafter. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again free these subjects from a diagnosis of PTSD. This study is the first time we are offering an additional MDMA-assisted psychotherapy session after a considerable amount of time has passed (up to 64 months) after completing assessments following the initial therapy.
4. MDMA-Assisted Psychotherapy Intern Study Protocol Under Development
On December 9, 2011, the MAPS clinical team met with the site team at Cartographie Psychedelica to plan for our planned intern study of MDMA-assisted psychotherapy for PTSD. This study will investigate the effectiveness of MDMA-assisted psychotherapy when one member of the standard male/female co-therapist team is a healthcare intern. The study will be led by Marcela Ot'alora G., M.A., L.P.C., and will take place in Boulder, CO. At the December 9 meeting, the clinical team began planning for a visit to the study site, and made some final adjustments to the study design. The team discussed the logistics of the trial site and Schedule I license application, reviewed investigator responsibilities according to Good Clinical Practice (GCP) guidelines, and determined how investigators could best prepare themselves for conducting the study. The protocol design stage has now been completed, and documents are being prepared for submission to FDA and Institutional Review Board. Discussions are underway for scheduling a five-day therapist training seminar for the Boulder team.
5. Contracts Finalized for Israeli Study of MDMA-Assisted Psychotherapy for PTSD
On December 25, 2011, MAPS and the Research Fund at Beer Ya'akov Mental Hospital finalized the contracts for our upcoming Israeli study of MDMA-assisted psychotherapy for PTSD. The Ethics Committee at Beer Ya'akov Mental Hospital approved the insurance certificate for the study on November 29, which was the final document required prior to finalizing the study contract. The Ministry of Health and the Ethics Committee has already approved the protocol. The second of three Israeli therapists have received MDMA in our therapist training protocol, with the third to receive MDMA in a few weeks. Our clinical team is now preparing for a study kick-off meeting with the site to prepare for screening Israeli subjects.
6. Health Canada Requests Additional Changes to Canadian MDMA/PTSD Study Pharmacy
On December 2, 2011, Health Canada sent a report of the results of their second security inspection to the manager of the pharmacy where the MDMA will be stored for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. The report summarizes several changes that will be needed at the pharmacy before Health Canada grants it the license to store the study MDMA. These include (1) the installation of an additional alarm system for the area surrounding the safe, (2) the reinforcement of the windows, door, and lock to the room containing the safe, and (3) the addition of the words "Restricted Drug" to the MDMA label. Health Canada requested additional information after their initial May 10 inspection, after which a follow-up took place on October 18. A third security inspection will be scheduled once we have made the required changes to the pharmacy site. The creation of additional security regulations following the initial inspection has delayed the security clearance, and therefore the study initiation, by almost six months.
The process of meeting the security requirements of Health Canada is exceedingly frustrating. At times, the amount of security required for about $1500 of MDMA seems absurd, as compared to security for other items at the pharmacy worth much more. Nevertheless, our policy is still to comply with whatever is required and to continue to persevere until we are able to start this study.
7. Protocol Design Completed for New Australian Study of MDMA-Assisted Psychotherapy for PTSD
On January 8, 2012, our clinical team finalized the basic design of the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The study, which will be led by Clinical Investigators Dr. Stuart Saker, MBBS, and Fiona MacKenzie, MPsych(Clinical), will compare the effectiveness of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD using two different dosages of MDMA: a full dose of 125mg (with a supplemental 62.5mg) and a low dose of 30mg (with a supplemental 15mg). Seven subjects will be allocated to the full dose condition, with the remaining five to the low dose condition. Subjects in this study will receive two experimental sessions instead of three, enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies. The lead investigators both completed MAPS' training course for MDMA-assisted psychotherapy researchers, which took place in Israel last January. The protocol will be submitted to an Independent Human Research Ethics Committee (HREC) by February 8, and to the Australian Therapeutic Goods Administration (TGA) once it has been approved. MAPS has pledged $25,000 to this study, which the researchers already matched with their own $75,000. We are now offering an additional $25,000 if they can raise an additional $75,000 in matching funds.
More Research News
8. MAPS' International Clinical Team Meets at Cartographie Psychedelica
MAPS' 25th anniversary Cartographie Psychedelica conference and celebration provided a rare opportunity for MAPS' international clinical research team to gather in person for a series of meetings to plan for the next steps in our ongoing MDMA-assisted psychotherapy for PTSD research program. On December 9, 2011, lead investigators, research coordinators, independent raters, interns, and other staff and associates met to discuss how training would be conducted for therapists and adherence criteria raters. Adherence criteria raters, who evaluate the extent to which therapists in our MDMA-assisted psychotherapy studies adhere to the methods outlined in MAPS' treatment manual, will be selected from qualified therapists or those who are working towards a license in therapy and have been trained by experienced raters. MAPS will also offer training in the techniques of MDMA-assisted psychotherapy for PTSD both to qualifying licensed therapists and to qualifying individuals who are still working towards their license. The clinical team also discussed the Psychedelic Education Program, which will be offered to the general public and include lectures and workshops on the history and science behind psychedelic-assisted psychotherapy trials.
9. Psychiatric Times Article on MDMA-Assisted Psychotherapy Tops "Most Popular Reads"
An article published last year in Psychiatric Times by psychiatrist Michael Mithoefer, MD, about the current state of research into the therapeutic potential of MDMA-assisted psychotherapy was at the top of the journal's list of "Most Popular Reads" for January 2012. Dr. Mithoefer and his wife and co-therapist Annie Mithoefer, BSN, are the lead investigators for MAPS' ongoing study of MDMA-assisted psychotherapy for veterans with PTSD. The popularity of the article indicates the growing interest in psychedelic-assisted psychotherapy research among medical professionals, therapists, and clinical researchers. Read "Does MDMA Have a Role in Clinical Psychiatry?"
10. UK Psychiatrist Publishes New Article on MDMA-Assisted Psychotherapy for PTSD
On December 15, 2011, a new article by UK psychiatrist Ben Sessa, M.D., on the potential of MDMA-assisted psychotherapy for treating PTSD was published online in the journal Progress in Neurology and Psychiatry ("Could MDMA be useful be in the treatment of post-traumatic stress disorder?" Volume 15, Issue 6). Sessa describes how 3,4-methylenedioxymethamphetamine (MDMA) has shown promise in the treatment of PTSD as an adjunct to post-trauma psychological therapy. However, because of historical associations with its use as the recreational drug Ecstasy, MDMA research remains a controversial subject. Sessa discusses these controversies and describes a possible future MAPS-sponsored, UK-based study of MDMA-assisted psychotherapy for PTSD. The article is available as a free download.
11. MAPS in the Media
MAPS' psychedelic and medical marijuana research and education continues to make headlines. Here's a sample of media hits from the past month.
Get the latest psychedelic and medical marijuana research news at MAPS in the Media, or visit our Audio and Video Archive.
- The Vancouver Observer speaks with MAPS researchers about the challenges of initiating a study of MDMA-assisted psychotherapy for PTSD in Canada. Read about how hard it can be to get approval to store a few grams of pharmaceutical MDMA. (January 4, 2012)
- Israel's Channel 2, Mako, publishes an interview with an Israeli psychiatrist about her experience undergoing MDMA-assisted psychotherapy as part of MAPS' training program for clinical therapeutic researchers. Read about our MDMA-assisted psychotherapy for PTSD research in Israel. (December 21, 2011)
- Alternet reports on MAPS' $10,000 grant for developing a protocol for a new study of MDMA-assisted therapy for adults with autism spectrum disorders and Asperger's syndrome. Read about autism, MDMA, and the science of emotion. (December 6, 2011)
- Catalyst Magazine published an enthusiastic review of MAPS' 25th anniversary Cartographie Psychedelica conference and celebration, highlighting the various facets of the four-day event that made it such a success. Read "Academia on Acid". (December 28, 2011)
- The Chronicle of Higher Education speaks with Brad Burge of MAPS about a new study of recreational Ecstasy use, the tricky issue of study design, and how sensationalist headlines can dangerously distort scientific results. Read the Ecstasy interview. (January 3, 2012)
- Brad Burge of MAPS speaks on PsychTalk Radio about how psychedelic drugs became stigmatized and what modern research is revealing about them. Listen to the PsychTalk interview. (December 20, 2011)
- MAPS Founder Rick Doblin, PhD, speaks with CKNW in Vancouver about recent headlines surrounding the dangers of recreational Ecstasy use, the benefits of MDMA-assisted psychotherapy for PTSD, and MAPS' efforts to conduct medical marijuana research. Listen to Rick Doblin's interview (mp3). (January 9, 2012)
12. National Geographic Documentary Series Zooms in on Psychedelics Sundays in January
Tune in Sundays in January for the National Geographic Channel's "Drugs, Inc." documentary series, which explores the politics, science, and controversies surrounding psychedelics, cannabis, and other substances. MAPS was a major resource for the producers of this series, providing both scientific expertise and connections to the psychedelic therapy research community.
An episode on ketamine will also air as part of this series on Sunday, January 22 at 9 PM EST/PST. See the episode guide for more information.
- "Ecstasy" (which aired Sunday, January 8) showed the social and environmental devastation caused by the criminal black market in Ecstasy pills, and explored what researchers know—and don't know—about the pure ingredient, MDMA. The episode included a segment describing the possible therapeutic benefits of MDMA-assisted psychotherapy. Watch this video excerpt of a real underground MDMA-assisted psychotherapy session.
- "Hallucinogens" airs this Sunday, January 15, at 9 PM EST/PST on the National Geographic Channel. The episode concludes with never-before-seen interviews with MAPS researcher Peter Gasser, MD, as well as a subject from our recently completed Swiss study of LSD-assisted psychotherapy for end-of-life anxiety.
13. Video of MAPS at 2011 Women's Visionary Congress Now Available Online
On July 30, 2011, MAPS staff members Amy Emerson (Clinical Program Manager) and Linnae Ponté (Executive & Clinical Research Assistant) gave an outstanding presentation at the 2011 Women's Visionary Congress. Their presentation addressed the prominent role of women in the field of psychedelic therapy research and explored who MAPS is, how it works, and why our attention to cultural and gender-related factors make MAPS an especially effective non-profit pharmaceutical development organization.
The Women's Visionary Congress is an annual gathering of visionary women healers, scholars, activists and artists who study consciousness and altered states. The WVC supports the transfer of knowledge among women who apply the insights of their research and spiritual path. Watch the presentation online or listen to the audio version (mp3, 49 MB).
14. New Biography of Albert Hofmann Chronicles the Life and History of LSD
If you don't read German, this book could be a reason to learn. Albert Hofmann and his LSD ("Albert Hofmann und sein LSD"), a new book in German by Dieter Hagenbach and Lucius Werthmueller, chronicles the exciting life and a short history of an important discovery—the LSD molecule. Few (if any) discoveries of the 20th century had a greater influence on science, society, and culture than this potent substance, which causes profound changes in consciousness at dosages of millionths of a gram. Eventually, LSD became the subject of thousands of clinical observations, a tool for obscure experiments in secret government labs, a propellant of the youth movement of the 1960s, a catalyst for the development of the computer industry, and a technology for creating a holistic relationship between humanity and its environment. Read the foreword by Stanislav Grof in English (PDF). The book may be purchased here.
15. Stanislav Grof Holotropic Breathwork Training Workshop: February 10-12, 2012, Los Angeles, CA
16. High Times Medical Cannabis Cup: February 11-12, 2012, Los Angeles, CA
Join MAPS at the High Times Medical Cannabis Cup at Los Angeles Center Studios from February 11-12, 2012. MAPS is hosting an educational art lounge on the top floor of Los Angeles Center Studios, and MAPS medical marijuana researcher Dr. Sue Sisley will speak on a panel of experts and activists about MAPS' efforts to start our FDA-approved but NIDA-rejected study of marijuana for veterans with PTSD. Network with experts in the medical cannabis research field and contribute to the exciting potentials of the cannabis community. Make sure to explore the MAPS Store and Art Gallery's collection of scientific knowledge and museum-quality masterpieces, with all proceeds going to MAPS.
17. IONS Total Immersion Noetic Film Experience: March 9-11, 2012, Petaluma, CA
From shamanic healing and psi research to meditation, mythology, and personal transformation, the Institute of Noetic Science's inaugural Noetic Film Experience weekend will have something for everyone. Join us March 9–11, 2012, at the IONS EarthRise Retreat Center in Petaluma, CA, where we will celebrate the power of film while sharing our experiences via panels, receptions, and Q&A with filmmakers and scientists. The lineup includes
Early registration discount ends February 13, so act soon!
- The Sacred Science, a documentary about seriously ill people who travel to Ecuador to work with shamanic healers.
- The Dhamma Brothers, a powerful documentary about the introduction of meditation techniques into a high-security Alabama prison.
- Maya 2012, the definitive guide to the spellbinding prophecy.
- Finding Joe, which explores the work of mythologist Joseph Campbell and his focus on The Hero's Journey.
- Something Unknown..., considered by many to be the best film on parapsychology research ever made.
- And many others...
18. Mind Altering Science: June 1-3, 2012, Amsterdam
The OPEN Foundation for interdisciplinary psychedelic research is now accepting papers for its next conference, Mind Altering Science 2012. The deadline for submission is February 19. With researchers and therapists from a wide variety of academic disciplines, this event will be dedicated to the exploration of a broad range of subjects relating to scientific research into psychedelic substances and the psychedelic experience. MAS was first organized in 2010; MAS2012 will be the second installment. The organizers welcome papers from the broad and interdisciplinary field of psychedelic science. Researchers who are still in the process of writing are also strongly encouraged to submit. Poster presentations are also welcome to apply. Papers can be submitted through this online form.
19. MAPS Canada Receives Official Non-Profit Status in Canada
On December 12, 2011, the Multidisciplinary Association for Psychedelic Studies Canada, Inc. was approved for federal non-profit status in Canada. MAPS Canada was officially incorporated on July 7, 2011. The next step will be to apply to the Canada Revenue Agency for charitable status so that donors can obtain tax deductions. MAPS and MAPS Canada are working together to conduct research into MDMA-assisted psychotherapy for PTSD and ayahuasca-assisted therapy for addiction. Meanwhile, Canadian citizens can make tax-deductible contributions to MAPS' projects through TIDES Canada's MDMA/PTSD Fund.
20. Seeking Research Participants: Experience with MDMA-Assisted Psychotherapy
A researcher not affiliated with MAPS invites you to participate in a dissertation study on the long-term effects of MDMA-assisted psychotherapy conducted outside of government-approved clinical research settings, provided you meet these qualifications:
- Have you undergone MDMA-assisted psychotherapy, as a client, at least two years ago?
- Are you willing to participate in a 1-2 hour interview about your experience?
21. Seeking Research Participants: Histories of Psychedelic Use in People over 65
A researcher not affiliated with MAPS is collecting histories of people older than 65 who have used psychedelic compounds. This is for a preliminary data collection which could lead to a study looking at whether some psychedelic use might be of benefit to older people. The researcher is looking for people over 65 who:
Names and contact information will be encrypted and replaced with anonymizing IDs for records. Drug use information will be used for research purposes and identifying information will not be given to law enforcement. This is an unfunded preliminary research effort. If interested, contact Brian Hanley, PhD, at brian (dot) paul (dot) hanley (at) gmail.com.
- have not used marijuana, or have not done so for 10 years or more
- are non-smokers (this applies to all substances)
- have generally good life habits
- have good levels of exercise
- are productive and contributing within their social milieu
- have reasonably good diets
- have some use of psychedelics in their lives at any age
- are willing to be interviewed