1. MAPS Clinical Plan for End-of-Phase 2 Meeting with the U.S. FDA to Develop MDMA as a Prescription Medicine for PTSD
On Monday, March 22, MAPS received final approval from our Institutional Review Board (IRB) to move forward with our new MDMA/PTSD study. (LINK TO IRB DOCUMENT) Michael Mithoefer, M.D. and Annie Mithoefer, BSN will conduct this new study in Charleston, South Carolina. They both ran the previous MAPS-sponsored US MDMA/PTSD study, which successfully demonstrated both safety and efficacy in treating treatment-resistant PTSD patients with MDMA-assisted psychotherapy and produced statistically and clinically significant findings. A scientific paper about the results is currently being evaluated for publication by a journal.
In the Mithoefers previous study of 21 people suffering from treatment-resistant PTSD, only two of the subjects were military veterans, and all but three of the subjects were women who were survivors of sexual assault or childhood sexual abuse. This new study will be conducted entirely with U.S. war veterans with PTSD. This study will help us determine if our treatment can be applied to people with PTSD from different causes or if our treatment itself needs to be modified to match the cause of the PTSD. Unlike the Mithoefers first study, which only had two groups (inactive placebo and full-dose MDMA), this study will compare three doses of MDMA--30 mg, 75 mg, and 125 mg, in an effort to enhance the double-blind. Most importantly, we will be testing what may become the protocol design that will be used in our large-scale, multi-site Phase 3 studies.
Because the Mithoefers previous study was the first study of its kind, we needed to establish a baseline of potential side effects of psychotherapy alone in people with PTSD who were treated with a placebo. People who received nothing but a placebo still reported side effects, so it was important that we have a pure placebo control, otherwise any of these side effects could be attributed to the MDMA. The rightful criticism of our first study, and the primary critique of the data so far, has been that it wasnt effectively double-blind because the subjects could easily tell if they were given the active drug or a placebo. That criticism will be addressed in the Mithoefers new study, and an active placebo of low-dose MDMA is being used in our other studies abroad--in Israel, Switzerland, Canada, Spain, and Jordan.
The Mithoefers new study will be a methodological response to the primary critique of our first study. In addition to our research in the United States, MAPS is currently engaged in MDMA/PTSD studies in several other countries around the world--Switzerland, Israel, and soon Canada, Jordan, and Spain. All of these studies are intended to prepare us for an End-of-Phase 2 meeting with the FDA, the purpose of which is to come to agreement with the FDA on the design of the large-scale Phase 3 studies that we want to conduct. At the meeting, we will review our data, and explain the methodological and statistical considerations in our proposed design of a large-scale, multi-site, Phase 3 safety and efficacy trial. Once weve come to an agreement on the design of our Phase 3 studies, if we get good results and show safety and efficacy, then the FDA will approve our application to market MDMA for PTSD patients.
The Mithoefers new study in veterans has been approved by both the FDA and the IRB, so now were waiting for the DEA to facilitate the licensing and transfer of the MDMA so we can begin this study. Michael and Annie Mithoefer will be giving a presentation about their work at the upcoming MAPS-sponsored Psychedelic Science conference in San Jose next month, and their workshop about MDMA and PTSD is already almost filled to capacity.
2. Update on Canadian MDMA/PTSD and Ayahuasca Studies and the Formation of MAPS Canada
There is good news from our friends north of the U.S. border. We have obtained approval in Canada for our MDMA/PTSD study from both Health Canada (in March 2009) and a Canadian Institutional Review Board (in May 2009). However, when Principal Investigator Ingrid Pacey, M.D. applied for a license to import the MDMA, she was told that theres a Canadian law which states that, because MDMA is a controlled substance, we cannot start the study without affiliation with a Canadian institution. In the United States, with Michael Mithoefer M.D.s study, we were fortunately able to proceed without an institutional affiliation other than MAPS.
On March 6, 2010, Dr. Pacey informed Health Canada in writing that we had obtained institutional affiliation with the Center for Addiction Research (CARBC) in British Columbia, associated with the University of Victoria. MAPS is currently waiting on Health Canada for their approval of our institutional affiliation, and for the licensing of Dr. Pacey and our pharmacist, so that we can import the MDMA from Switzerland for the study and finally begin.
MAPS is currently forming a new non-profit corporation in Canada--MAPS Canada-- that will allow Canadians to give tax-deductible donations that help to fund MAPS-sponsored psychedelic research. MAPS currently has an association with Tides Canada, which acts as MAPS Canadian fiscal sponsor until weve established MAPS Canada. It will be more efficient when were able to have our own organizational tax deductible status in Canada, just like we do in the U.S. So far, the Board of Directors for MAPS Canada consists of Mark Haden, Philippe Lucas, Kirk Tousaw, Robert Barnhart, Valerie Mojeiko, and Rick Doblin, Ph.D.. Were seeking one additional Canadian so that the Board will be majority Canadian.
The formation of this new organizational branch of MAPS grew out of the successful fund-raising event that MAPS had in Vancouver, British Columbia on October 24, 2009. MAPS Canada will be involved with both helping to support the MDMA/PTSD study in Vancouver, and also an ayahuasca study in the treatment of addiction, being conducted by Philippe Lucas.
This will be our first Ayahuasca study, which will be using natural plant extractions. We will explore whether Ayahuasca administered within a spiritual context can be helpful in treating people who have problems with addiction. Philippe Lucas, who is leading the study, will be speaking about this research at the Psychedelic Science in the 21st Century conference. In fact, there will be an entire track of presentations about Ayahuasca at the conference, with talks by Philippe Lucas, Stephen Beyer, and many others.
3. Swiss MDM/PTSD Study Completes Active Treatment Phase
Our Swiss MDMA/PTSD study has now completed active treatment of all 12 subjects and has obtained data from the two-month follow-up. The long-term follow-up (12 months post-treatment) is still underway, and will not be completed until January 2011.
The results were promising, approaching significance but only reaching the .1 level. The underlying reduction in PTSD symptoms was larger than the reductions obtained in the Zoloft and Paxil studies, which led to their approval by the FDA for the treatment of PTSD. If this study had been somewhat larger with more subjects, the results we obtained would become significant.
The leading researcher in this study, Peter Oehen, M.D., will be reporting on his results from this study at the upcoming Psychedelic Science in the 21st Century conference.
4. MAPS Continues Protocol Development and Planning of Spanish MDMA/PTSD Study
In Spain, MAPS is in the protocol development stage for a study being conducted by Jose Carlos Bouso, Ph.D., Jordo Riba, Ph.D., and Manel Barbanoj M.D. Weve agreed upon the protocol design with this team of researchers, and were now in the process of elaborating it into a full protocol for submission to their Hospitals Institutional Review Board, and then the Swiss Ministry of Health.
Once approved, this study will mark our overcoming the political suppression of our early MDMA/PTSD study in Spain. Jose Carloss MAPS-sponsored study in Madrid had been the worlds first MDMA/PTSD pilot study, started in 2000 and shut down in 2002 by the Madrid Anti-Drug authorities for political reasons. Weve posted more information about the history of our early MDMA/PTSD study in Spain, as well as a paper by Jose Carlos Bouso, reporting on the results that we were able to obtain.
This study will be the only one of our pilot studies that uses an active placebo thats not MDMA. In this study, well be testing d-amphetamine as the active placebo. Were also going to be intensely focusing on evaluating videotapes of the first several therapy sessions using our adherence criteria for our revised treatment manual. All of our MDMA/PTSD studies now will start with a more intensive review of the videotapes of the first several sessions by raters to quantify therapist adherence to the therapeutic method. Over time, this should help us to make our training of therapists more effective, which will make our treatment itself more effective.
5. MAPS Closes Initial Phase of Israeli MDMA/PTSD Study
In our Israeli MDMA/PTSD study, weve currently completed a preliminary analysis of the data. All five of the subjects enrolled to date have been treated without any evidence of harm. However, while there is some evidence of efficacy, its minimal. Weve decided to close out this initial study and postpone new treatments until we have obtained adequate therapeutic training for members of our Israeli co-therapist team.
6. Update on the Jordanian MDMA/PTSD Study
The Jordanian MDMA/PTSD study that MAPS is sponsoring has been approved by the Jordan IRB, and will soon be submitted to the Jordanian FDA. A team of five Jordanians from Al-Rashid Hospital in Amman will be coming to the United States from April 6th to 12th for an MDMA/PTSD therapist-training session, which will be held in Charleston, South Carolina and taught by Michael Mithoefer M.D. and Annie Mithoefer B.S.N. MAPS Executive Director Rick Doblin will be there on the first day of their arrival to welcome them all to the U.S., to express his appreciation for their coming to learn about MDMA, and to let them know how important their project is to MAPS. After the MDMA/PTSD therapist-training seminar, the five Jordanians from the Al-Rashid Hospital will travel to San Jose, California to participate in our Psychedelic Science in the 21st Century conference.
7. Monitoring Visit Conducted on Swiss MDMA and LSD Studies
In late February, MAPS Clinical Operations Manager Amy Emerson, Deputy Director Valerie Mojeiko, and MAPS new clinical research specialist Berra Yazar Ph.D., conducted a monitoring visit in Switzerland. They worked with Peter Oehen M.D. on the Swiss MDMA/PTSD study, which has completed treating all 12 patients, to help prepare the data for reporting to Swiss Medic and the FDA, and also for writing an article for submission to a scientific journal.
This same team also paid a monitoring visit to Peter Gasser M.D.s MAPS-sponsored Swiss LSD/end-of-life study. The monitoring visit revealed that its more difficult than we had originally anticipated to work with people who are close to dying, because their underlying disease process affects their health and their anxiety, as well as their ability to come to the psychotherapy sessions on a schedule.
Swiss LSD researcher Peter Gasser had a teleconference with Rick Doblin, Ph.D., MAPS Research and Information Specialist Ilsa Jerome, Ph.D., and MAPS Clinical Research Associate Berra Yazar, Ph.D. They discussed ways to align the windows during which certain procedures should be taking place with the diminished abilities to keep to a schedule of the actual patient population that they are working with.
8. Marijuana PTSD Study in the Works in Arizona
MAPS is currently working with Principal Investigator Sue Sisley M.D., of Phoenix, Arizona to develop a new marijuana/PTSD protocol in order to get a marijuana study underway in the U.S. Weve already developed a protocol summary. Were anticipating that the protocol will be ready for submission to the Institutional Review Board (IRB) and the FDA this summer. Were sadly anticipating that this study is likely to be delayed for at least a year by NIDAs review process-- should they even approve it, which is doubtful. In addition, were asking for marijuana with THC and CBD in it, which NIDA does not have available.
There is not at yet a possibility of importing any marijuana into the United States that contains significant amounts of both THC and CBD. This shows clearly how the DEA support of NIDAs monopoly on the supply of marijuana for research is fundamentally obstructing drug development research aimed at transforming marijuana into an FDA-approved prescription medicine. The DEA/NIDA obstruction of FDA research is one of the primary reasons why state medical marijuana reform efforts are essential.
9. Professor Craker, UMass, and MAPS Efforts to Create a Privately-Funded Medical Marijuana Production Facility
Since 2001, MAPS has worked with Professor Craker at UMass Amherst to try to obtain a license for our own production facility of marijuana for FDA-approved research. NIDA currently has a monopoly on cannabis production for research purposes, and the DEA has been protecting that monopoly, which fundamentally obstructs drug development research for a number of reasons.
President Obama has recently nominated Michelle Leonhart as the new DEA Administrator, which will complicate the fate of our marijuana drug development efforts. Since 2004, Leonhart has been the Acting Deputy Administrator of the DEA, after being appointed by President Bush. Although she had several jobs, shes been in a leadership role at DEA, and has been behind the crackdown on the state medical marijuana patients, growers, and providers. Most significantly, she rejected the February 12, 2007, recommendation of DEA Administrative Law Judge Mary Ellen Bittner, who found that it would be in the public interest for Professor Craker to receive a DEA license for the production of marijuana for research.
Professor Crakers lawyers have filed a motion to reconsider to Michele Leonhart, with her response still pending. President Obamas nomination of her to be the Administrator of the DEA is not encouraging, even though President Obama has also ordered his Attorney General Eric Holder to stop the DEA raids on cannabis dispensaries in states that allow medical marijuana, so long as they are operating in compliance with state law. Were hoping that opening the door to scientific research is something that President Obama, his senior staff, members of Congress, and members of the Senate confirmation hearing will understand is a priority principle that Michele Leonhart needs to share to be confirmed as the next Administrator of DEA.
We expect the senate confirmation hearings to take place in the next month or two. We strongly encourage people to contact their Senators about the Michelle Leonhart confirmation, saying that she should not be confirmed unless theres a pledge to accept the recommendation of the Administrative Law Judge, or a pledge to facilitate medical marijuana research and not protect the NIDA monopoly.
10. Last Chance to Register for Psychedelic Science Conference: April 15th-18th
The Psychedelic Science in the 21st Century conference that MAPS will be hosting next month in San Jose, from April 15th-18th is gathering enormous momentum and were all very excited about it. Andrew Weil, M.D., Stanislav Grof, M.D., Ph.D., Charles Grob, M.D., Earth and Fire Erowid, Alex and Allyson Grey, and many others will be there. Almost every psychedelic research project on the planet will be represented at the conference, with lectures by the worlds leading experts. Over 800 people have registered, and the conference is now at full capacity.
11. Pre and Post-Conference Seminars
We would also like to encourage people to check out the pre- and post-conference workshops that will be taking place at the conference, as were reaching maximum capacity with some of those. The workshop with Michael and Annie Mithoefer and me about MDMA/PTSD research and our therapeutic method is almost full. The wonderful news is that visionary artists Alex and Allyson Grey will both be at the conference! As many of you are aware, Alex and Allyson were recently in a serious car accident that injured some of the vertebrae in their backs. Were happy to report that the Greys are both doing better, and that they will be able to attend the conference--in their body casts--to lecture, lead a pre-conference workshop, and unveil Alexs new painting of Sasha Shulgin at the benefit dinner.
In order to facilitate the continual growth of the psychedelic renaissance into further social acceptance, were using our main public conference as an opportunity to spread awareness about psychedelic research, and we have also created a two-day seminar to take place on Tuesday April 20th and Wednesday April 21st. This will be for the researchers to speak among themselves, in a peer-to-peer, non-media context about the actual fundamental issues that are raised by this research, and to explore opportunities for mutual collaboration, and sophisticated methodological challenges by the worlds most knowledgeable peers.
12. MAPS Outreach at SSDP Conference in San Francisco March 13-14
Students for a Sensible Drug Policy (SSDP) organized a conference in March that was attended by 470 campus activists in San Francisco to network, strategize, and share updates on the War on Drugs and the widening range of youth resistance efforts. MAPS Executive Director Rick Doblin gave three different talks at the conference, Events and Outreach Coordinator Brian Wallace had a membership table there, and Deputy Director Valerie Mojeiko interviewed several SSDP people for job opportunities at MAPS.
There is a great article about the SSDP conference on Alternet.
Someone at the SSDP conference asked Rick Doblin, Are psychedelics back? Rick replied, If you’re talking about college campuses, psychedelics never left.
13. Alex Grey Podcast with MAPS
Alex Grey recently spoke to Ken Allen on our Psychedelic Spotlight podcast series promoting Psychedelic Science in the 21st Century conference. They discuss Alex and Allysons recent car accident and his upcoming workshop at the Psychedelic Science conference.
14. April Playboy Magazine Article About the Psychedelic Renaissance
The April issue of Playboy magazine ran a positive feature article by Steven Kotler about the new medical research into psychedelics entitled The New Psychedelic Renaissance. The article juxtaposes two stories; that of a dying woman seeking the help of an underground psychedelic therapist, and an overview of the resurgence of scientific research into the therapeutic potential of psychedelics, including the work that MAPS has been doing.
15. Spring MAPS Bulletin on Its Way to Members
MAPS members should check their mailboxes, and be on the lookout for the special theme bulletin that David Jay Brown edited about psychedelics, death and dying. This exciting new issue includes fascinating interviews with Joan Halifax, Ph.D., Charles Tart, Ph.D., Roland Griffiths, Ph.D., Alicia Danforth, Ph.D.c., Peter Gasser, M.D. and Stanislav Grof, M.D., Ph.D., as well as contributions by Ralph Metzner, Ph.D., David Nichols, Ph.D., and Charles Grob, M.D., Brummbaer, Andrew Android Jones, and others. Considering that the dying process is probably the most universally feared of all human experiences, that the death of loved ones causes more suffering in this world than anything else, and that death appears to be an inevitable fact of nature--we believe that the idea of using psychedelics to ease the dying process is worth exploring. Thats why this special edition of the MAPS Bulletin brings together scientific researchers, undertakers, caregivers, physicians, poets, and artists to explore the important relationship between psychedelics, death and dying. A digital version of this bulletin is also available on online.
16. Save the Date! Horizons NYC, Sept 24-26
Horizons is a forum for learning about psychedelics, held annually in New York City. The goal of the conference is to open a fresh dialogue on the role of psychedelics in medicine, culture, history, spirituality, and art. Previous speakers have included researchers from NYU, UCLA, Johns Hopkins, Purdue, the University of Zurich, and numerous writers, historians, artists, and thought leaders. Horizons 2010 will be the conferences fourth year.
In the 1950s and early 1960s, legal research with psychedelics spurred important discoveries in science and psychology. During the 1960s, psychedelics entered worldwide popular culture. Questions about their safety, medical value, history and implications in politics and culture were unfortunately answered with numerous myths spread by both users and the media.
In recent years, a small group of dedicated researchers, scholars, and activists has orchestrated a renaissance that is re-shaping the publics understanding of these unique substances. Horizons brings together the brightest minds and the boldest voices of this movement to share their research, insights, and dreams for the future.
17. Check out AlterNets Drug Reporter for up to the Minute Drug Policy News
AlterNet’s Drug Reporter newsletter is a great way to stay on top of the cutting edge of the failed war on drugs, the US’s incredible and rapid transformation to tolerate marijuana and the fascinating and ever expanding world of psychedelic research. Drug Reporter brings you the latest on the tragic and horrific Mexican drug war, discoveries about the healing potential of ecstasy and LSD -- sign up now. http://www.alternet.org/newsletter/subscribe/
18. New Movie: Dirty Pictures, Chronicles the Shulgins and Other Psychedelic Luminaries
Dirty Pictures is a documentary directed by Etienne Sauret about Dr. Alexander Sasha Shulgin, the rogue neurochemist who invented hundreds of psychedelic drugs and introduced MDMA (aka Ecstasy) to society at large. His discoveries have brought him into conflict with the law, but made him a worldwide underground hero. Dirty Pictures examines Dr. Shulgin’s lifelong quest to unlock the mysteries of the human mind.
The film recently was shown to sell out crowds at South By Southwest in Austin Texas. The film will be screened at a theatre near the Psychedelic Science in the 21st Century conference in San Jose California on Saturday, April 17, 2010.
19. Patients out of Time Conference in Rhode Island, April 15-17
If you cant make it to San Jose, California for Psychedelic Science in the 21st Century, perhaps you can make it to the Patients Out of Time medical cannabis conference in Rhode Island, April 15-17. We chose to have this conference simultaneously for the synergies amongst our psychedelic research renaissance and the medical marijuana movements great successes. In fact, we will be broadcasting Andrew Weil live from our conference to the Patients Out of Time conference. You can learn more by watching this Youtube clip.