New Pioneers of Psychedelic Psychotherapy: MAPS News – July 2009
Dear MAPS Supporters and Friends,
I returned this week from Europe where I had the opportunity to meet with all of MAPS’ MDMA/PTSD researchers for our first ever therapist training seminar. This was a momentous event in MAPS’ history, which has laid the foundation for future research and future therapist training programs. You can read more about the retreat below.
We have several events in the near future that you should be aware of. For those of you in the San Francisco Bay area, we will be hosting a brunch on Saturday, August 8 in Santa Cruz. Later that day, MAPS President Rick Doblin will speak at a psychedelic salon in San Francisco. We will be co-hosting the Drug Policy Alliance’s international drug policy reform conference in Albuquerque, New Mexico in November and we need volunteers to help us at the event. In case you haven’t marked your calendar yet, we are hosting an international conference on psychedelic research in April of 2010. Our friend Dean Chamberlain is displaying his Psychedelic Pioneers series in Venice, California. There are details below about all of these events.
This month’s gift of the month is Beyond the Basin, a new novel by MAPS Bulletin contributor Alexander Beiner. This is a fascinating tale of a Westerner’s life becoming intertwined with a shamanic tribe. We will give this book to any current member who donates $25 or more or to any new member who donates $50 or more. We have a limited supply of books, so order quickly.
Randolph Hencken, MA
Director of Communications and Marketing
Here’s a sample of what is happening this month at MAPS:
- MAPS’ First MDMA/PTSD Therapist Training Seminar
- Training Protocol Seeks to Administer MDMA to Therapists
- Preliminary Data from US MDMA/PTSD Pilot Study Submitted to FDA
- MDMA/PTSD Manuscript Submitted to Journal on July 8
- Vancouver Observer Article: Healing Severe Trauma with MDMA
- Professor Craker’s Attorneys File Second Status Update in Court of Appeals
- Israeli Medical Marijuana Database Created
- WAMM Wins National Social Action Award
- Brunch with Rick Doblin and MAPS Staff in Santa Cruz, August 8
- Journeybook Launch with Razam, Parish, and Doblin Sat, August 8 in San Francisco
- Join MAPS at Reform! Albuquerque, New Mexico, November 12-14
- Psychedelic Science in the 21st Century Conference, April 2010
- Chamberlain’s Psychedelic Pioneers Series at 99 High Art Collective in Venice, CA
- Support MAPS by Donating Items for our Holiday Auction
- Gift of the month: Beyond the Basin by Alexander Beiner
* * * Dues-paying MAPS members are empowering staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase books, clothes, art, and other merchandise, visit: store.maps.org/ * * *
From June 25 to July 1, therapists and researchers from seven countries (US, Canada, Spain, Switzerland, Germany, Israel, Jordan) convened in Austria for a one-week MDMA/PTSD therapist training seminar. This seminar was MAPS’ first attempt to provide some formal educational sessions to therapists working, or considering working, on MAPS-sponsored MDMA/PTSD clinical trials. MAPS has identified the training of co-therapist teams as the fundamental challenge in conducting our current Phase 2 studies and possible future Phase 3 studies, for which we would need to train about 20-30 new co-therapist teams.
The seminar began with introductions, then moved into the presentation of results from our US, Swiss and Israeli studies, followed by a description of the core elements of our treatment manual, the watching of videotapes of therapeutic sessions from our US, Swiss and Israeli studies, and group discussions of a range of topics. The third day of the conference was devoted entirely to holotropic breathwork sessions, to enable people to experience the therapeutic potential of a non-ordinary state of consciousness. The schedule of the seminar is available on the MAPS website.
In attendance were, Dr. Michael Mithoefer and Annie Mithoefer, BSN, from our US Study; Dr. Ingrid Pacey and Andrew Feldmar, PhD, from our Canadian study; Dr. Sergio Marchevsky and Dr. Tali Nachoni from our Israeli study; Dr. Peter Oehen and Verena Widmer, RN, from our Swiss study; Jose Carlos Bueso, PhD, and Gema Guarch from Spain; Dr. Fady Hannah-Shmouni from Jordan; June May Ruse PsyD, principal author of our MDMA/PTSD treatment manual; psychologist Marcela Otalora Gomez from Boulder, Colorado, who worked as a co-therapist on our initial Spain MDMA/PTSD study; Dr. Torsten Passie, MDMA research expert from Germany; and the MAPS staff, including President Rick Doblin, PhD, Director of Operations Valerie Mojeiko, Research and Information Specialist Ilsa Jerome, PhD, Director of Communications and Marketing Randolph Hencken, MA, and Accountant, IT and Chef Josh Sonstroem. A photo of these new pioneers in psychedelic psychotherapy is on our website.
Two days were dedicated to reviewing videotapes of MDMA sessions from the US, Swiss, and Israeli studies. Every few minutes the tapes were stopped for fruitful discussions about how the therapists handled the situation in the video. There was an incredible range of comments about how the therapists and patients interacted, and numerous suggestions were made about alternative means of counseling a patient in similar circumstances. This provided for lively dialogue about the wide range of responses that a therapist could offer at any given moment. These discussions were very exciting to hear — but also presented us with a new challenge as we confronted the need to retool our treatment manual in order to create a consistent methodology. The treatment manual is designed to give guidance to people who may or may not have ever provided MDMA-assisted psychotherapy. Since there is so much individual variation in therapist style, and it’s difficult to understand the implications of therapist style to clinical outcomes, it’s a daunting task to try to narrow down the most effective key elements of the therapeutic method. However, we still believe that our therapist manual offers great guidance. We also know more than ever that there is a lot of revising to do. We wish to refine the method and operationalize a checklist that independent raters viewing videotapes of therapeutic sessions could use to quantify therapist adherence to the method.
In addition to viewing the videotapes, we had good discussions about different approaches to treating PTSD, the current state of and future revisions to the treatment manual, and the challenges of working in different cultural contexts. One entire session was devoted to the cultural challenges we will face when we begin our study in Jordan. For instance, we learned from Fady Hannah-Shmouni that some of the techniques used by our European and North American therapists, such as having male/female co-therapist teams, and touching and making physical contact with patients during therapy, may be inappropriate with some patients in Jordan.
One of the important outcomes of the training program was a decision to add a measure of functionality to all of our future protocols. Our primary outcome measure is the Clinician Administered PTSD Scale (CAPS), which measures symptoms of PTSD. We now realize the value of including a measure of functionality that would quantify changes, such as what we saw in the US pilot study — three patients who had been unable to work for years returned to work after their treatment.
At the retreat, Michael Mithoefer, Torsten Passie, and Rick Doblin had productive discussions about the protocol design for our upcoming study in US veterans with PTSD from the Iraq, Afghanistan and other wars. Ilsa Jerome and Rick are including new ideas from those discussions into the development of that study protocol, which we are planning to submit to FDA within the next two months.
On Sunday, June 28, Michael and Annie Mithoefer and Ingrid Pacey led Holotropic Breathwork sessions for the group (Michael, Annie, Ingrid, and Rick have all completed Holotropic Breathwork training with Dr. Stanislav Grof). This was a great addition to the seminar. Some of our researchers had not had any personal experiences with non-ordinary states of consciousness. Doing the breathwork permitted people to feel what it is like to explore emotions in a non-ordinary state of consciousness.
Canadian videographer Oliver Hockenhull came to the retreat during the last days to do interviews for his upcoming feature-length film, A Perfect Pill: From Neurons to Nirvana, and to create short web interviews for the MAPS website. We will be posting these interviews on the MAPS website over the next few months.
The MAPS staff gathered together after the seminar for a celebratory dinner, which took place in Munich. The seminar was a successful demonstration of MAPS’ growing organizational capacity. It was highly valued by the participants, as indicated in an anonymous feedback form distributed and filled out after the last session of the seminar. We are considering having a similar, yet shorter, meeting for current psychedelic researchers, after our April 2010 Psychedelic Science in the 21st Century conference.
On June 22, 2009, we submitted a protocol to FDA seeking permission to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS’ MDMA/PTSD studies. We learned that we could provide much in the way of educational experiences during our therapist training seminar. Nevertheless, we also believe it will benefit therapists administering MDMA to patients to have a personal subjective understanding of MDMA’s effects when administered to them within a therapeutic setting. The only way such an MDMA experience can be legally provided to therapists is through an FDA protocol designed for that purpose. The protocol requires possible participants in the MDMA training sessions to have first successfully completed a MAPS-conducted therapist training program.
There is a precedent from the 1970s for our therapist training protocol. Dr. Albert Kurland’s LSD research team at Spring Grove Hospital had FDA permission to administer LSD to help train nurses, attendants and others working with patients in clinical studies, and to mental health professionals (doctors, therapists, counselors, priests, rabbis) to help them better understand patients or congregants who had experienced LSD or other psychedelics. Over 100 people received LSD in those training sessions. We submitted letters to FDA from one of the researchers conducting that training program, Johns Hopkins researcher William Richards, PhD, and from a participant who reported long-term benefits to his therapeutic skills.
This protocol, if approved, will significantly enhance our ability to train therapists to work more effectively on our MDMA/PTSD studies. We should hear from FDA within 30 days of submission.
On June 22, 2009, we also submitted to FDA safety and efficacy data from our US MDMA/PTSD pilot study. The safety data was submitted along with our therapist training protocol to enable the FDA to more fully evaluate the risks to therapists potentially volunteering for our training protocol. The efficacy data was submitted to help the FDA understand why we believe the results from our pilot study justify expanding our research into more Phase 2 and eventually Phase 3 studies, for which we will need to train 20-30 more co-therapist teams.
On July 8, 2009, after months of extensive data analysis, numerous drafts, and our own informal peer-review process by friendly but tough readers, we submitted a manuscript about our US MDMA/ PTSD study to a scientific, peer-reviewed journal. The authors of the manuscript are Dr. Michael Mithoefer, Mark Wagner, PhD, Annie Mithoefer, BSN, Ilsa Jerome, PhD, and Rick Doblin, PhD.
Publishing our data in a peer-reviewed journal is a crucial step in communicating to the scientific and psychotherapeutic communities the exceptional potential of MDMA-assisted psychotherapy in subjects with treatment-resistant PTSD. While we hope the paper will be accepted by the first journal we submitted it to, we’re prepared to keep working on the paper until it is accepted for publication and indexed on Medline. Traditional pharmaceutical companies often forgo submitting their data for publication and only submit their data to FDA in order to keep their research secret from their competitors. MAPS differs in that our approach is to be transparent, freely sharing our data with other research groups and the public. For us, the full value of the study itself will not have been obtained until the data is published in a peer-reviewed journal. The data will be available to MAPS members once it is published.
The Vancouver Observer, an online publication, published a feature story (permalink) about our planned MDMA/PTSD study. Journalist Brandi Cowen interviewed Principal Investigators Dr. Ingrid Pacey and Andrew Feldmar, PhD, as well as MAPS President Rick Doblin, PhD for the story. The Canadian research project will start as soon as the government grants the research team a license to import MDMA.
On July 2, 2009, Professor Lyle Craker’s ACLU Drug Law Reform Project lawyers filed the Second Status Update with the US Court of Appeals, First Circuit. The update reports on DEA’s lack of response to the witness and document list filed with DEA on June 5, 2009, in support of Prof. Craker’s Motion to Reconsider DEA’s Final Ruling. The lawyers are asking the Court to hold the appellate proceedings inabeyance until we learn the DEA’s final decision. DEA’s final order was scheduled to go into effect July 1, 2009, but DEA lawyers have previously indicated that it is not unusual to have a Motion to Reconsider still pending after the effective date of a final agency order.
Craker’s lawyers are required to file a status report with the Court of Appeals every 60 days until a decision is finalized by DEA. These status report filings preserve Craker’s right to appeal should DEA deny him a license to grow marijuana for research purposes at UMASS Amherst, under contract to MAPS. We are currently comfortable with DEA’s delay as we are hoping that new leadership at DEA will soon be appointed by the Obama administration. New leadership at DEA will hopefully be more likely to reverse the rejection of the Administrative Law Judge (ALJ)’s recommendation to license Prof. Craker than the Bush-holdovers still running DEA who initially rejected the ALJ’s recommendation.
On July 1st 2009, the first version of the Israel Medical Marijuana database (shared by all Ministry of Health approved Medical Marijuana growers, distribution centers and patients) was released and demonstrated to the Israeli Ministry of Health. The database was built as a collaboration between Shlomi Vakin of Tel Aviv, Mimi Peleg of Wo/Men’s Alliance for Medical Marijuana (WAMM) who is moving to Israel soon, and MAPS (with significant help from MAPS staff member Joshua Sonstroem), and with support from an anonymous donor.
The database is for Israeli medical marijuana patients and was originally hosted on the MAPS website. The database has now been transferred to a server used by the Israeli Ministry of Health. Data will be collected that can be used for future research about medical marijuana’s efficacy, benefits and risks, and the cost of medicines replaced by medical marijuana. The database is based on OpenEMR, an open source Electronic Medical Records software used in clinics worldwide both for clinic and patient management, and in collecting statistical medical information. The customized version of this program will be stored in English on the MAPS server for other medical marijuana projects to download, use, and modify.
The Society for the Study of Social Problems (SSSP), a national organization of sociologists, has honored MAPS’ sister organization, Wo/Men’s Alliance for Medical Marijuana (WAMM), with the 2009 Social Action Award.
WAMM, a not-for-profit patient-caregiver cooperative in Santa Cruz, California, has since the early 1990s collectively grown and given away millions of dollars worth of cannabis to seriously and terminally ill patients. The $1,000 Social Action Award will be presented to WAMM at the SSSP annual dinner in San Francisco on Saturday August 8th at 8 p.m.
MAPS is hosting a brunch in Santa Cruz, California on Saturday, August 8, 2009, at 10 AM at Peachwood’s Steakhouse (located at the Inn at Pasatiempo, 555 Highway 17). This is an opportunity for people in the Santa Cruz area to meet Rick Doblin and MAPS staff members from MAPS’ operational headquarters. Rick will talk, and take questions, about the state of the organization, future plans, and other psychedelic and medical marijuana-related matters. Brunch is $25 and reservations are encouraged by Tuesday, August 4, and required by Friday, August 7 at 4 PM. Tickets are available on MAPS’ website (https://maps.org) or by calling MAPS’ office at 831-429-6362. The brunch is open to MAPS members and the general public. Proceeds benefit MAPS.
Come celebrate the San Francisco launch of the Journeybook, the world’s best psychedelic anthology. The book launch will feature author readings by Rak Razam and Tim Parish, and a Psychedelic Salon panel discussion by leading experts, including MAPS President Rick Doblin, PhD, and MAPS guest editor David Jay Brown, MA, as well as live electronic music, psyart gallery space and more.
If you haven’t yet heard, MAPS is hosting a conference, Psychedelic Science in the 21st Century, in the San Francisco Bay Area, from April 16-18, 2010. We are bringing leading psychedelic researchers from around the world to present the state of the art of psychedelic research. We are planning to offer continuing education credits for physicians, psychologists, social workers, and nurses. We will be honoring Sasha and Ann Shulgin for their lifetime of achievements at a special benefit dinner on Saturday evening, April 17.
Dean Chamberlain’s light paintings of psychedelic pioneers Timothy Leary, Albert Hofmann, Richard Alpert aka Ram Dass, Laura Huxley, Terence McKenna, Richard Evans Schultes, John Lilly, Nina Graboi, Ann & Sasha Shulgin and Oscar Janiger, are on display at 99 High Art Collective in Venice, California. Proceeds from sales of the prints benefit MAPS.
This month we are pleased to offer a Beyond the Basin, a new novel by Alexander Beiner. Beyond the Basin follows the intertwining narratives of a young journalist and a little girl living in an undiscovered shamanic tribe. Exploring the social and metaphysical implications of humanity’s communion with psychedelics, this gripping piece of visionary fiction seeks to unravel some of the mysteries around these amazing substances. We will give this book to new donors who give $50 or more, or to current members who give $25 or more. We only have 24 copies of this book – so order quickly. If you are donating primarily to receive the book, please call our office at 831-429-6368 before making a payment in order to verify that we still have copies remaining.
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