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Media > Newsletter: August 11, 2006



Greetings, MAPS Members, Supporters, and Friends!

The prospects for international psychedelic drug development are looking better than ever. Last month, our Israeli MDMA/PTSD research team received government approval to import MDMA into Israel and then our Swiss MDMA manufacturer received government approval to export MDMA to Israel. In the meantime, MAPS learned that philanthropist Peter Lewis agreed to donate $250,000 to fund MAPS-sponsored MDMA/PTSD pilot studies in the US, Israel and Switzerland. As misunderstanding and violence continues to escalate in the Middle East, it's clear that technologies of peace and healing--like MDMA-assisted psychotherapy--will continue to be desperately needed in the coming years.

Later this month, MAPS will celebrate its 20th Anniversary at Burning Man, where this year's theme is "The Future: Hope and Fear." For us at MAPS, this theme seems to synchronize with our current outlook: encouraged, given the seemingly-impossible obstacles we have already overcome, but also humbled, aware that our greatest work still lies ahead.

Here's the headlines for August:

1. Peter Lewis Donates $250,000 for MAPS-Sponsored MDMA/PTSD Research in the US, Switzerland and Israel
2. Israeli Import Permit and Swiss Export Permit Approved; MDMA Arrives in Israel
3. Swiss MDMA/PTSD Study Fully Approved, Set to Begin in September
4. Dr. Mithoefer Treats 13th and 14th Patients in US MDMA/PTSD Study
5. Swiss LSD/End-of-Life Anxiety Study Design Expanded to 12 Subjects
6. Provisional Approval from Canadian IRB for MAPS-Sponsored Long-Term Ibogaine Observational Case Study
7. MAPS Teams Up with MPP to Lobby AMA, Awaiting Recommendation in Prof. Craker's MAPS-Sponsored Lawsuit for Marijuana Production Facility
8. Headed to Burning Man? Here's Where to Find MAPS
9. MAPS-Sponsored Psychedelic Harm Reduction at Portugal's Boom Festival
10. John Hopkins Study Demonstrates Link Between Psilocybin and Spiritual Experience
11. Alex Grey's "St. Albert" Auction Set for October
12. Call for Papers: "Pleasure and Drugs"
13. Watch "The ACLU Freedom Files: Drug Wars" Online
14. Asheville Fundraiser Builds Support for MAPS; Robert Barnhart Donates $20,000

***Want to renew your MAPS membership? Make a restricted donation? Browse our online store? We can't do what we do without YOU!***

1. Peter Lewis Donates $250,000 for MAPS-Sponsored MDMA/PTSD Research in the US, Switzerland and Israel

On July 28, philanthropist Peter Lewis awarded MAPS a grant of $250,000 to fund MAPS-sponsored Phase II pilot studies of MDMA-assisted psychotherapy for subjects with treatment-resistant posttraumatic stress disorder (PTSD) in the US, Switzerland and Israel. For more on the current status of these studies, see items #2, #3, and #4.

Peter Lewis' new grant is in addition to his donation in March 2006 of $250,000 to McLean Hospital for Dr. John Halpern's MAPS-initiated (but no longer MAPS-sponsored) study of MDMA-assisted psychotherapy in advanced-stage cancer patients with anxiety.

2. Israeli Import Permit and Swiss Export Permit Approved; MDMA Arrives in Israel

On Thursday, August 3rd, in the midst of war, about 5 grams of MDMA arrived in Israel for MAPS' MDMA/PTSD study, imported into Israel from Switzerland. The MAPS-sponsored MDMA/PTSD pilot study is being directed by Moshe Kotler M.D., with Dr. Rael Strous and Dr. Rakefet Rodrigez serving as the male/female co-therapist team. This study has full government approval and will be initiated in Fall 2006. If she is able to leave her psychiatric work in Israel, Dr. Rodrigez will come to Burning Man to work with and receive further training from Dr. Mithoefer and others at Sanctuary.

3. Swiss MDMA/PTSD Study Fully Approved, Set to Begin in September

Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD trial also has full government approval and has also received the necessary MDMA from the same Swiss manufacturer that supplied our Israeli study. The study is expected to begin this September.

4. Dr. Mithoefer Treats 13th and 14th Patients in US MDMA/PTSD Study

Dr. Michael Mithoefer continued treatment of the 13th and 14th patients out of 20 in his flagship 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. On July 21, after treating the 13th patient with the second experimental session that included the supplemental dose, Dr. Mithoefer described the experience as "impressive." We're grateful to the FDA for negotiating with us to modify and enhance the protocol based on data gathered during the early stages.

MAPS' MDMA/PTSD pilot studies in the US, Switzerland and Israel will take the next two years to complete. Then we'll evaluate the data to determine whether to proceed with large-scale Phase III studies that will be required to demonstrate to FDA the safety and efficacy of MDMA-assisted psychotherapy for PTSD for possible prescription use. For more information on MAPS' $5 million, 5-year plan, see "A Clinical Plan for MDMA (Ecstasy) in the Treatment of Post-Traumatic Stress Disorder (PTSD)," by MAPS President Rick Doblin, Ph.D.

5. Swiss LSD/End-of-Life Anxiety Study Design Expanded to 12 Subjects

As we reported in the June 2006 email update, MAPS and Dr. Peter Gasser have begun work on the design of a study that will investigate LSD-assisted psychotherapy in subjects suffering from anxiety associated with advanced-stage cancer and other life-threatening illnesses. Dr. Gasser's study is in the early stages of protocol design.

MAPS originally pledged to donate $50,000 for this study, which MAPS has already raised from the sale of art and books signed by Albert Hofmann. Because of budgetary concerns, we had initially intended to design an open-label study with four subjects to gather basic information on safety for this patient population and to develop a treatment approach. However, as a result of MAPS' increasing fundraising capacity and optimism, we've decided to expand the study design to 12 subjects and increase the budget to $150,000. MAPS will be seeking grants for the additional $100,000 and hopes to raise the remaining funds before the study is fully approved, which we expect will take place around December, 2006 (prior to Albert Hofmann's 101st birthday on January 11, 2007). If approved, this will be the first LSD-assisted psychotherapy study conducted in about 35 years.

This LSD/end-of-life anxiety study will complement Dr. John Halpern's MAPS-initiated research investigating MDMA-assisted psychotherapy and Dr. Charles Grob's Heffter-sponsored research investigating psilocybin-assisted psychotherapy, both with subjects suffering from anxiety associated with advanced-stage cancer.

MAPS' grand plan is to complete three MDMA/PTSD pilot studies and two pilot studies (in MDMA and LSD) addressing anxiety associated with end-of-life issues over the next two years, so that we will have a wide range of data to help us plan strategically for potential Phase III studies.

6. Provisional Approval from Canadian IRB for MAPS-Sponsored Long-Term Ibogaine Observational Case Study

After years of work and a number of significant changes to the original protocol, a MAPS-sponsored research team has received "conditional approval" from a Canadian Institutional Review Board (IRB) to proceed with a long-term observational case study that will examine changes in substance use in 20 consecutive people seeking ibogaine-based addiction treatment for opiate dependence at Iboga Therapy House in Vancouver. While originally designed as an "outcome study," the protocol was later changed to an observational case-study when the IRB expressed concerns that the initial design was too close to a clinical trial, which has a much stricter approval process, and was never the intention of the research team anyhow. The Principal Investigator is none other than Rick Doblin, Ph.D., and he'll be aided by Dr. Ken Alper and Leah Martin, with data analysis to be conducted by MAPS Research Associate Ilsa Jerome, Ph.D.

On August 9, British Columbia's The Tyee published "Psychedelics Could Treat Addiction, Says Vancouver Official," reporting that Vancouver's top drug policy official and B.C. public health physicians believe addicts might be treated by giving them psychedelic drugs, and they hope the city will lead in exploring the controversial approach.

7. MAPS Teams Up with Marijuana Policy Project to Lobby American Medical Association, Still Awaiting Recommendation in Prof. Craker's MAPS-Sponsored Lawsuit for Marijuana Production Facility

MAPS and medical marijuana reform advocates nationwide are eagerly awaiting a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner within the next several months in Prof. Craker's MAPS-supported lawsuit against the DEA for refusing to license a privately-funded medical marijuana production facility at 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. This MAPS-funded facility 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.

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. Towards this end, MAPS initiated a campaign last week with David Ostrow, M.D., who is funded by the Marijuana Policy Project (MPP), to lobby the American Medical Association (AMA) to pass a two-fold resolution at this November's annual meeting. The first part of the resolution says that privately-funded, FDA-approved research into marijuana's potential therapeutic uses should be encouraged, and that privately-funded production facilities that meet all regulatory requirements should be licensed by DEA to produce pharmaceutical-grade marijuana for use exclusively in FDA- and DEA-approved research. The second part of the resolution says that in states where patients are permitted to use medical marijuana for serious and/or chronic illnesses and the patient's physician has recommended its use in accordance with that states medical practice standards, that patients should not be subject to federal criminal penalties for such appropriate medical use.

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, 38 members of the US House of Representatives, and the California and Texas State Medical Associations, the two largest US state medical associations. If we do receive a positive recommendation, we will need all MAPS supporters to contact their Congressional Representatives, so keep an eye out for news on this front!

For more information, see MAPS' DEA lawsuit page.

8. Headed to Burning Man? Here's Where to Find MAPS

As you probably know by now, MAPS will be celebrating its 20th anniversary at Burning Man in Nevada's Black Rock Desert from Aug. 28 to Sep. 3. MAPS will be hosting a theme camp in association with artists Alex and Allyson Grey, Roberto Venosa, Martina Hoffmann, and a great team from Chicago organizing the infrastructure. We will also be assisting the Black Rock Rangers to provide psychedelic emergency services in an area known as "Sanctuary" as well as helping coordinate a lecture series in the Entheon Village theme camp. Coincidentally, this is also Burning Man's 20th anniversary. If you are planning to attend Burning Man, but not camping with us, you can find the lecture series at 4:00 and Esplanade. To check out the amazing line-up for this year's lecture series, featuring Sasha & Ann Shulgin, Rob Kampia, Ethan Nadelmann, Alex & Allyson Grey, Daniel Pinchbeck, Earth & Fire Erowid, John Gilmore, Dr. Michael Mithoefer, MAPS President Rick Doblin, and many more, click here.

We are no longer accepting applications for volunteers at Sanctuary. For those of you who have applied to volunteer at Sanctuary but have yet to receive official reply, you will be contacted within the next week.

There are a few spots remaining to camp with MAPS at Entheon Village. Click here to register.

For more about Entheon, please see the thick description in last month's update.

9. MAPS-Sponsored Psychedelic Harm Reduction at Portugal's Boom Festival

As a result of MAPS' work at Burning Man, MAPS has been asked to provide psychedelic emergency services at the Boom Festival in Portugal from August 3-9. The Boom Festival organizers awarded MAPS $9600 for staff travel and other expenses and provided 23 free tickets and a week's worth of food to our eight core team members and our 15 volunteers.

Our team of therapists consists of Dr. Peter and Verena Oehen from Switzerland (MDMA/PTSD researchers), Dr. Andrew Sewell from Harvard (LSD/Psilocybin in cluster headache researcher), Jose Carlos Bouso, Ph,D., from Spain (MDMA/PTSD researcher), Sandra Karpetas (ibogaine researcher) and several others from Vancouver, Canada, along with fifteen other volunteers.

10. Modern Continuation of Classic "Good Friday" Experiment at John Hopkins Demonstrates Link Between Psilocybin and Spiritual Experience; Media Reacts Enthusiastically

On Tuesday, July 11, a National Institute on Drug Abuse (NIDA) and Council on Spiritual Practices (CSP)-funded research team from John Hopkins University published in Psychopharmacology the first modern-day continuation of the Good Friday Experiment, finding that psilocybin induced spiritual experiences in most subjects. A former NIDA director and a former deputy director of ONDCP supported the results of the study in associated commentaries published with the article, but the current NIDA director issued a statement distancing NIDA from the study. The study attracted a lot of serious media coverage from the Wall Street Journal, The Economist, NPR, the Washington Post, ABC News, and several other large outlets, and is a major step toward the legitimization of psychedelic research.

11. Alex Grey's "St. Albert" Auction Set for October

Now that 49 out of 50 of Alex Grey's limited edition signed portraits of Albert Hofmann have been sold, MAPS and the Chapel of Sacred Mirrors (COSM) will hold an Ebay auction in October to sell the last remaining print, numbered 1/50. We will announce the exact date of the auction in next month's email update. Profits from the sales of the portraits have been divided between MAPS, with funds restricted for LSD and psilocybin research and for supporting Albert's writings, and COSM. MAPS and COSM have raised over $42,000 each from sales of these portraits.

12. Call for Papers: "Pleasure and Drugs"

The International Journal of Drug Policy (IJDP) has issued a call for papers for a special upcoming issue with a focus on the role of pleasure in drug use and harm reduction, which will be guest edited by Martin Holt and Carla Treloar of the National Centre in HIV Social Research, Australia. Outline abstracts (no more than 250 words) are invited before September 5. If you're interested, reply to this email and I'll send you a document with a full summary of the call for papers.

13. Watch "The ACLU Freedom Files: Drug Wars" Online

"The ACLU Freedom Files: Drug Wars" premiered on Court TV on June 15, and is now available to view online. This riveting 30-minute documentary focuses on four issues: racist drug raids, the Drug War in schools, excessive prison sentencing, and medical marijuana.

The ACLU Drug Law Reform Project, based in Santa Cruz, CA, is one our new drug policy neighbors, and has supported MAPS by providing pro bono legal services in Prof. Lyle Craker's ongoing lawsuit against DEA/NIDA/HHS for obstructing his proposed MAPS-sponsored medical marijuana production facility.

14. Asheville Fundraiser Builds Support for MAPS; Robert Barnhart Donates $20,000

On July 24, MAPS held a dinner fundraiser in Asheville, NC, featuring presentations by 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. Thank you to event organizer Logan MacSporran, artist Jelena Cvetkova, chef Josh Sonstroem of Sirius Catering, and Jinx at the Flood Gallery for making this event possible.

The event was successful, particularly thanks to Robert Barnhart, who traveled all the way from Austin, Texas for the dinner. He was so inspired by the event that he donated $20,000 to MAPS a week later in an unrestricted gift! Thank you, Robert!


Have an Awesome August,

Jag Davies, MAPS Director of Communications

























































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