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MAPS Bulletin Spring 2014: Special Edition: Psychedelics and Education
 
Media > Newsletter: July 7, 2006



Greetings, MAPS Members and Friends!

We have lots of news to report this month:

1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects Receive Supplemental Doses of MDMA or Placebo
2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study
3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored MDMA/PTSD Research Receives Final Regulatory Approval
4. MAPS Purchases 35 Grams of Research Grade MDMA from Swiss Manufacturer
5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for MAPS-Sponsored Study
6. MAPS-Sponsored MDMA/PTSD Research in Spain Resuming Active Protocol Design and Approval Process
7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine Outcome Protocol this Month
8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches Published in Neurology, the Journal of the American Academy of Neurology
9. Journal of Pychopharmacology and Quarterly Journal of Mental Health Accept Papers Advocating Psychedelic Research
10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for MAPS-Sponsored Medical Marijuana Production Facility
11. Upcoming MAPS Fundraiser on July 24 in Asheville, NC
12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration
13. Now in the MAPS Online Store: Limited Edition Ram Dass Portrait by Dean Chamberlain
14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!
15. Request for Calendar Art, Calendar Dates, T-Shirt Design
16. Classic 'Good Friday Experiment' Now Posted Online
17. $25,000 Grant to MAPS for Erowid.org

***Like What You're Reading? Click Here to Support MAPS' Work With A Financial Contribution!***

1. FDA-Approved Changes to US MDMA/PTSD Study Implemented; New Subjects Receive Supplemental Doses of MDMA or Placebo

Dr. Michael Mithoefer has now begun treatment of the 13th and 14th patients out of 20 in his MAPS-sponsored MDMA/PTSD study, implementing several key changes recently approved by the FDA, IRB, and Data Safety Monitoring Board. These changes include administering a supplemental dose of MDMA (or a placebo) 2 to 2 1/2 hours after the initial dose and adding a third experimental session to the two that are currently included in the protocol.

The first subject to receive this supplemental dosing experienced an extended period of therapeutic activity without any worrisome increase in blood pressure or heart rate. This initial reaction, while in only one subject, suggests that this protocol change may enhance the therapeutic effectiveness of the experimental treatment without significantly increasing risk.

2. MAPS Receives $25,000 Donation for US MDMA/PTSD Study

MAPS has just received a $25,000 donation from the Robert T. Keeler Foundation, restricted for Dr. Mithoefer's MDMA/PTSD study. This is the second $25,000 donation for Dr. Mithoefer's study from the Robert T. Keeler Foundation, the first donated a year ago. MAPS is seeking an additional $100,000 for this study.

3. MAPS and Swiss Medical Association for Psycholytic Therapy-Sponsored MDMA/PTSD Research Receives Final Regulatory Approval

Switzerland's DEA equivalent, the BAG, has officially given the necessary licenses for Dr. Peter Oehen's study evaluating MDMA-assisted psychotherapy as a treatment for subjects suffering from treatment-resistant Posttraumatic Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle, since Dr. Oehen has already received approval from the Ethics Committee (Switzerland's IRB equivalent) and SwissMedic (Switzerland's FDA equivalent). In addition, MAPS Clinical Research Associate Valerie Mojeiko has completed preparation of Case Report Forms (CRFs), Standard Operating Procedures (SOPs), and other documents that must be submitted to FDA under MAPS' Investigational New Drug application for MDMA in the treatment of PTSD. Dr. Oehen will receive the MDMA for his study within a few weeks and can then begin his study.

MAPS and Dr. Oehen are also going to collaborate with Dr. Franz Vollenweider, University of Zurich, on an associated study that will examine the subjects in Dr. Oehen's study before and after treatment with MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several physiological factors that have been associated with PTSD (startle response, heart rate reactivity) as well as various EEG parameters to see if the MDMA-assisted psychotherapy results in any changes in these measures.

MAPS is seeking an additional $100,000 for this study.

4. MAPS Purchases 35 Grams of MDMA for Swiss and Israeli MDMA/PTSD Studies

MAPS has completed the purchase of 35 grams of MDMA of a purity of 99.66% from a Swiss manufacturer for use in MAPS' MDMA studies that take place outside of the US. The same batch of MDMA has been used before in clinical research in Switzerland and will be used in Dr. Oehen's MDMA/PTSD study. This same MDMA will be exported to Israel for use in MAPS' Israeli MDMA/PTSD study. The cost was about $57 per gram.

5. Israeli MDMA/PTSD Team Receives Permit to Import MDMA for MAPS-Sponsored Study

The Israeli MDMA/PTSD team received a permit this week to import MDMA from a Swiss manufacturer for the MAPS-sponsored study set to take place at Beer Yaakov Mental Health Center near Tel Aviv. Once the Swiss BAG issues an export permit, the MDMA can be shipped to Israel. This is the final step before initiation of Dr. Moshe Kotler's clinical trial evaluating MDMA-assisted psychotherapy in treatment-resistant subjects with war and terrorism-related PTSD.

MAPS is seeking an additional $50,000 for this study.

6. MAPS-Sponsored MDMA/PTSD Research in Spain Preparing to Resume Protocol Design and Approval Process

Jose Carlos Bouso, Ph.D., has returned to the protocol design and approval process for his MAPS-sponsored MDMA/PTSD study. This study was the world's first government-approved MDMA psychotherapy study, with six patients treated in 2001-02. However, in 2002, in response to positive reports about the study that appeared in the Spanish media, the Madrid Anti-Drug Authority pressured the hospital into withdrawing permission. The Ministry of Health has not withdrawn permission, and we are hopeful that since we have now obtained government approval for MDMA/PTSD studies in the US, Switzerland, and Israel, it will be politically feasible to resume research in Spain around the beginning of 2007, with a different protocol design. As a result of the political suppression of his initial MDMA/PTSD study, Jose Carlos had to initiate and complete a different research project for his dissertation before he was able to return his attention to his MDMA/PTSD study.

Jose Carlos is now in the midst of writing up for publication the results from the six subjects treated in his initial study. Ilsa Jerome, Ph.D., MAPS' expert on the scientific literature on MDMA, is assisting Jose Carlos by reviewing and commenting on early drafts of his paper.

7. Canadian Institutional Review Board to Review MAPS-Sponsored Ibogaine Outcome Protocol this Month

This week, MAPS submitted a revised version of the ibogaine case series observational study protocol to a Canadian Institutional Review Board (IRB). We have been negotiating for several months with an IRB for the observational study of 20 opiate dependent subjects to be treated at the Iboga Therapy House. We have incorporated the latest set of comments and suggestions and have submitted the protocol for review at an upcoming meeting on July 19.

8. Findings About LSD/Psilocybin as Treatment for Cluster Headaches Published in Neurology, the Journal of the American Academy of Neurology

A paper by Andrew Sewell, M.D., coauthored by John Halpern, M.D., and Harrison G. Pope Jr., M.D., describing MAPS-sponsored LSD/psilocybin cluster headache research, has been published in Neurology, the official journal of the American Academy of Neurology. The article contains interviews with people who have treated cluster headaches with LSD or psilocybin mushrooms, and reviews their medical records. Neurology is a top specialty journal, read by most neurologists throughout the world, so news of this promising use of LSD and psilocybin will be widely disseminated among doctors for the first time.

Andrew Sewell, M.D., and John Halpern, M.D., collected and analyzed hundreds of case reports from Erowid and Clusterbusters, an organization run by and for people with cluster headaches dedicated to evaluating new treatments for cluster headache, including the use of psilocybin and LSD. Based on this data, Drs. Sewell and Halpern are currently developing a protocol for a randomized, dose-response study of psilocybin and LSD in people with episodic cluster headaches.

Currently, there is no legal research with LSD in humans taking place anywhere in the world. We hope that this will be the first study to renew human research into the therapeutic use of LSD. Due to the previously expressed concerns of the new McLean Administration, funding for any clinical study will be provided by Clusterbusters, until the McLean Administration becomes comfortable again accepting research support from MAPS.

9. Journal of Pychopharmacology and Quarterly Journal of Mental Health Accept Papers Advocating Psychedelic Research

Ben Sessa, M.D., a British psychiatrist working courageously and effectively towards the resumption of psychedelic research in England, recently had two papers regarding psychedelic-assisted psychotherapy research accepted for publication in two key international academic journals. The first paper, "Is there a case for MDMA-assisted Psychotherapy in the UK?" will appear in the peer-reviewed Journal of Psychopharmacology, and draws on evidence from MAPS-sponsored FDA Phase I and Phase II research studies. The second paper, "From Sacred Plants to Psychotherapy: The History and Re-Emergence of Psychedelics in Medicine," will appear in the peer-reviewed Quarterly Journal of Mental Health.

10. Multiple Sclerosis Foundation Sends Letter of Support to DEA for MAPS-Sponsored Medical Marijuana Production Facility

This week, the Multiple Sclerosis (MS) Foundation sent a letter to DEA Administrator Karen Tandy urging DEA to issue a Schedule I license to Prof. Lyle Craker for his proposed MAPS-sponsored medical marijuana production facility at the University of Massachusetts-Amherst. Prof. Craker's proposed facility would end the government's six decades-long monopoly on the production of marijuana for research purposes and would create the necessary independence of supply to justify the time and expense for MAPS to sponsor clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved prescription medicine.

The MS Foundation letter is in support of Prof. Craker in his ongoing MAPS-supported lawsuit against DEA taking place in a DEA Administrative Law Judge (ALJ) hearing. With oral arguments complete and the final legal briefs submitted, we are now awaiting a recommendation from ALJ Mary Ellen Bittner, expected in 2-4 months. In the meantime, we are focusing our attention on preparing to pressure the DEA to accept Judge Bittner's recommendation if she actually recommends that the DEA should issue a Schedule I license to Prof. Craker. DEA has already received letters of support for Prof. Craker's marijuana growing facility from Americans for Tax Reform, the Lymphoma Foundation of America, the National Association for Public Health Policy, the United Methodist Church, the American Medical Students Association, several state nurses' associations, the Massachusetts Dept. of Public Health, Massachusetts Senators Kerry and Kennedy, and 38 members of the US House of Representatives.

This latest letter was the result of work by MAPS' part-time staffer Kelly Burns, who is currently laying the groundwork for an effort to obtain a letter from the American Medical Association to DEA, urging DEA to issue Prof. Craker's license so that the controversy over the medical use of marijuana can be resolved through scientific research. We expect that such a letter from the AMA would require action by the AMA House of Delegates at its November 2006 meeting. Any physicians who belong to their state Medical Associations who wish to help in this effort should contact Kelly at: .(JavaScript must be enabled to view this email address)

11. Upcoming MAPS Dinner Fundraiser on Monday, July 24 in Asheville, North Carolina

MAPS will be holding a dinner fundraiser on Monday, July 24 in Asheville, North Carolina. MAPS researchers Dr. Michael and Annie Mithoefer (co-therapists for MDMA/PTSD study) and Dr. Andrew Sewell (LSD/psilocybin research), along with MAPS President Rick Doblin, Ph.D., and MAPS Program Director and Clinical Research Associate Valerie Mojeiko will each give presentations. The event will also feature a delicious 5-course tasting menu courtesy of Sirius Catering and an art installation by Jelena Cvetkova, with proceeds of art sales going to MAPS.

We have only thirty-five seats available for this special opportunity to dine intimately with MAPS researchers and staff. Tickets 1-10 will sell for a minimum donation of $45, tickets 11-20 for a minimum donation of $50, and tickets 21-35 for a minimum donation of $55. To RSVP, ask questions, and purchase tickets, please contact Logan MacSporren at .(JavaScript must be enabled to view this email address) or 772-708-6810.

12. Camp with MAPS at Burning Man for MAPS' 20th Anniversary Celebration

Registration is now open for ENTHEON village at Burning Man, an interactive theme camp on the Esplanade that is a co-creation of MAPS on the occasion of its 20th anniversary, artists Alex and Allyson Grey, Robert Venosa and Martina Hoffmann, and a great team from Chicago building much of the infrastructure and organizing the community kitchen. Entheon Village is hosting psychedelic elders Ann and Sasha Shulgin, numerous current psychedelic researchers, several domes for art, a large tent structure for a psychedelic research and culture lecture series and music concerts, a Zen meditation center (Zendo) being built in Switzerland and transported to Burning Man, and kitchen, showers, shade structures and places for about 250 people in tents and RVs. All you need to bring are your personal camping structure and supplies, some extra food and water, and a helping hand.

The mission of Entheon is to demonstrate a future in which psychedelic experiences, emergent from the underground, are a welcomed and integrated part of society, and where art, spirituality and creativity is central to that vision. Entheon will be a grounded gathering place offering an intellectual, therapeutic, artistic and creative cornucopia of interactive opportunities. The village of Entheon will merge science and healing, art and spirituality in a site for celebration. As part of its offerings to the Burning Man community, MAPS is assisting the Burning Man Rangers at Sanctuary to provide support to people going through difficult emotional experiences, about half psychedelic-related and half from other causes.

Please note that after you register on the website, you will be sent an email to which you must respond before your registration is activated. If you can pay your full camp fee up front, rather than making a deposit, please do. Each individual must register separatelythe system does not allow people to register in groups.

We are also accepting applications for volunteers who are interested in working with us at Sanctuary. To receive more information and an application to volunteer in Sanctuary, please contact Valerie Mojeiko at: .(JavaScript must be enabled to view this email address)

Note for First-Time Burners: Camp fees for Entheon Village are separate from tickets to the Burning Man event itself. Everyone MUST purchase their own Burning Man tickets separately. These are for sale on the Burning Man website. There you will find an extremely useful first-timers guide which is recommended reading for anyone who has never been before.

To sign up for ENTHEON village, click here.

13. Limited Edition Ram Dass Portrait Now Available

We are pleased to announce the availability of signed portraits of Ram Dass (Richard Alpert), the fourth in a special signed and numbered limited edition of prints selected from Dean Chamberlain's Psychedelic Pioneers Series. There are only 50 of these beautiful signed and numbered archival pigment prints. The image is 11"x14" and is printed on fine-art matte paper. Prints numbered 1-10 are offered at $1000 each, prints numbered 11-40 are offered at $1500 each, and prints numbered 41-50 are offered at $2000 each. Profits from the sale of these prints will be used for MAPS-sponsored research in Switzerland into the use of LSD-assisted psychotherapy in subjects with anxiety associated with end-of-life issues. MAPS is also offering signed portraits of Albert Hofmann, Sasha and Ann Shulgin, and Laura Huxley, also created by Dean Chamberlain. Please visit our online store or contact .(JavaScript must be enabled to view this email address) if you would like to purchase one of these prints.

14. Three Prints of Alex Grey's Portrait of Albert Hofmann Now Available!

We are now making available for purchase three out of the series of 50 numbered prints of Alex Grey's portrait of Albert Hofmann, signed by Albert, for sale for $3000. Forty-six out of 50 prints have already been sold. Profits from the sales of the portraits will be divided between MAPS, with funds restricted for LSD and psilocybin research and for supporting Albert's writings, and Alex and Allyson Grey's Chapel of Sacred Mirrors (COSM). Please contact .(JavaScript must be enabled to view this email address) if you would like to purchase one of these prints.

After these three prints have been sold, MAPS and COSM will auction off on Ebay the last remaining print, numbered 1/50.

15. Calling Creative MAPS Supporters: New MAPS T-Shirt Designs and Calendar Art

We are currently requesting submissions of art for the 2007 MAPS calendar. If you have a piece of art that you think would go particularly well with a certain month, or if you have something that is generally psychedelic and would fit in anywhere, we'd love to see it! Keep in mind that we can only use high-resolution digital images. The deadline for calendar submissions is July 21. Please send submissions to: .(JavaScript must be enabled to view this email address)

On that note, we're also seeking information about interesting and amusing psychedelic- and marijuana-related events that took place on a specific date to add to the dates featured in the 2006 MAPS calendar. If you have any suggestions, please send them to .(JavaScript must be enabled to view this email address)

MAPS will also be producing one (or possibly two) new t-shirts to add some variety to our MAPS-logo t-shirt and hoodie offerings. If you are inspired to submit a t-shirt, hoodie, or bag design, please feel free to do so anytime this summer. Submissions must be in by September 1st and will be chosen by mid-September. The new t-shirt line will be out mid-autumn 2006. Please email t-shirt designs to: .(JavaScript must be enabled to view this email address)

16. Classic 'Good Friday Experiment' Now Posted Online

Dr. Walter Pahnke's classic 1963 Harvard thesis, "Drugs & Mysticism: An Analysis of the Relationship between Psychedelic Drugs and Mystical Consciousness," better known as the 'Good Friday Experiment,' has been scanned by MAPS and is now posted online in PDF format. This landmark study evaluated the potential of psychedelic drugs to catalyze religious experiences. Rick Doblin's undergraduate thesis "Pahnke's 'Good Friday Experiment': A Long-Term Follow-Up and Methodological Critique," consisted of interviews and questionnaires administered to most of the subjects in the original study twenty-five years after the experiment took place.

This coming Tuesday, July 11, a prominent peer-reviewed scientific journal will publish the first attempt to replicate the results of the Good Friday experiment in over forty years, with a different experimental design and several remarkable supportive commentaries from well-established scientists.

MAPS has also now posted an amazing and long-lost LSD session report from Dr. Stan Grof, from 11-17-1970. We recently found this in MAPS' files, after Stan's copy was burned up years ago in a fire that consumed his home and collected papers. Stan took 250 micrograms of LSD and was wired to EEG machines and other monitoring equipment. While under the influence of LSD, Stan conducted ESP experiments and explored a range of unusual mystical/spiritual states of mind. The session was conducted by Dr. Walter Pahnke, who conducted the Good Friday Experiment, on which the new study was loosely based. The new study and Stan's trip report both point to the tremendous potential of psychedelic research, which we are only now starting to explore again after decades of repression.

17. $25,000 Donation to MAPS for Erowid.org

MAPS Patron Member John Gilmore recently donated $25,000 to MAPS, restricted for Erowid.org. MAPS serves as the fiscal sponsor for Erowid, an educational website focused on providing information about psychoactive plants and drugs. Erowid is the most frequently visited psychoactive drug information site on the web.


We have completed our move to our new office location in Ben Lomond, CA and are now back in full operation. From everyone at MAPS, thank you for your support! We couldn't be doing what we do without you!


Have A Gently Jolting July,

Jag Davies, MAPS Director of Communications


























































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