Greeting MAPS Members and Friends,
The new year has arrived, and here at MAPS we have already made some amazing breakthroughs. After celebrating the 100th Birthday of Albert Hofmann in Basel, Switzerland, we return to our work initiating MDMA studies in Switzerland and Israel. As we make progress in our clinical research goals, we are striving to increase our accessibility to a wider audience. This month, we are pleased to present a podcast for your listening enjoyment–created for this email news update by MAPS staffer Jag Davies about MAPS DEA medical marijuana lawsuit. So after you read the latest news, give your eyes a break and take in some information in audio form. Please give us your feedback, and let us know whether you would like us to make podcasts a monthly feature.
***If you are not a MAPS member yet, or if your membership has expired, please consider joining MAPS! If you are already a member, we can always use additional support. Please consider making a special donation to support your favorite project.***
And now the news:
1. Final Testimony in DEA Lawsuit Cancelled; Lawyers Now Working on Final Legal Briefings
2. MDMA Study in Switzerland Nearly Ready to Begin
3. US MDMA/PTSD Study Now at Halfway Point–Data Under Review
4. Israel MDMA/PTSD Study Moves Forward
5. Ibogaine Outcome Study Protocol Submitted to IRB
6. Two Womens Entheogen Fund Awards Announced
7. LSD Conference in Basel, Switzerland
8. Ayahuasca-Themed Issue of the Journal of Psychoactive Drugs
9. Merchandise Available at MAPS
10. In Memoriam: Carla Higdon, MAPS staffer from 1995-2001
1. Final Testimony in DEA Lawsuit Cancelled; Lawyers Now Working on Final Legal Briefings
To hear a podcast that goes into greater detail about this item, featuring interviews with Dr. Lyle Craker, Rick Doblin, and Al Byrne, click here.
Oral arguments in Professor Lyle Craker’s DEA Administrative Law Judge hearings about DEA refusal to issue a license for a MAPS-sponsored medical marijuana production facility have officially come to a close. DEA lawyers cancelled the final hearing, scheduled to take place on January 17th, in which they had planned to cross-examine Al Byrne, a medical marijuana advocate who has seen the poor quality of NIDA’s “research-grade” marijuana first-hand. After DEA lawyers learned that Al Byrne was willing to testify under oath, they decided they didn’t really want to hear what he had to say!
Lawyers from the ACLU Drug Law Reform Project and two Washington D.C. law firms working pro bono are now turning their attention to final legal briefings. No date has yet been set for when the briefs are due but we expect it will be in March or April. MAPS expects a decision from Judge Mary Ellen Bittner by early summer. If Judge Bittner recommends that DEA grant a license to Prof. Craker, we will then need to generate major political pressure on DEA Administrator Karen Tandy, encouraging her to accept rather than reject the recommendation. You can read background information, media coverage, and court transcripts from the case on the MAPS website.
2. MDMA Study in Switzerland Nearly Ready to Begin
On December 27, 2005, we received a report from Swiss psychiatrist Dr. Peter Oehen saying that he has received final approval for his MDMA/PTSD study from the ethics committee. This study will be co-funded by MAPS and the Swiss Medical Association for Psycholytic Therapy. Dr. Oehen submitted his protocol to Swissmedic (the Swiss FDA) for a review process, and received comments back from them in mid-January. The changes they suggested were all relatively minor, with no suggested changes to the protocol design. This study will test the efficacy of three MDMA sessions, rather than just two, and will use supplemental dosing of half the initial dose administered about 2 hours after the first dose. This procedure extends the period of maximum therapeutic effectiveness. On January 10, MAPS Clinical Research Associate Valerie Mojeiko, MAPS President Rick Doblin, and MDMA researcher Dr. Michael Mithoefer met with Dr. Oehen in Solothurn, Switzerland for a prestudy monitoring visit. We are planning another monitoring visit in early March to begin the study.
3. US MDMA/PTSD Study Now at Halfway Point–Data Under Review
Dr. Michael Mithoefer, Principal Investigator of the MAPS-sponsored MDMA/PTSD psychotherapy study in Charleston, South Carolina, filed an Annual Status Report with his Institutional Review Board (IRB) in December. There have been no drug-related Serious Adverse Events (SAEs) and the results on treatment efficacy are very promising. The IRB approved the project for another year, and the data, now at halfway, is currently being reviewed by the Data Safety Monitoring Board (DSMB). A total of eleven of 20 subjects have completed the study. We are now preparing a letter to the FDA requesting that the protocol be revised so that we can be permitted to add a third experimental session and supplemental dosing, to evaluate whether these methods can increase therapeutic effectiveness even further.
4. Israel MDMA/PTSD Study Moves Forward
In Israel, as we reported in November, Dr. Moshe Kotler, Chair, Department of Psychiatry, Sackler School of Medicine, Tel Aviv University and former chief psychiatrist of the Israeli Defense Forces, has received all approvals for his MAPS-sponsored MDMA/PTSD study. We are now working to obtain MDMA for the study from Switzerland so that the same MDMA will be used in both the Swiss and Israeli studies. We are now working to schedule a visit by the Israeli co-therapists, Dr. Rael Strous and Dr. Rakefey Rodrigez, to Charleston, SC, to observe Dr. Michael and Ann Mithoefer conduct an MDMA/PTSD session, hopefully around the end of March or in early April. Dr. Strous, Director of Research at the Beer Yaakov Mental Health Center, has published several interesting papers about PTSD in war veterans and holocaust survivors which can be viewed on the MAPS website.
Fundraising efforts have now started for this study, seeking the necessary $100,000. We have recently received a donation of $10,000 for this important project from MAPS Patron donor Ami Shinitzky. We are planning a pre-study monitoring visit to the site of this study in early March 2006.
5. Ibogaine Outcome Study Protocol Submitted to IRB
MAPS’ protocol for an outcome study of ibogaine in the treatment of addiction has been submitted to a Canadian IRB, and we have received feedback. All of the concerns with the protocol seem relatively easy to address. The IRB basically just asks for more information about the treatments. The protocol is only for the outcome study, not the treatments themselves, which will be provided legally on a fee-for-service basis by the Iboga Therapy House, directed by Sandra Karpetas. MAPS has hired Philippe Lucas to shepherd the protocol through the IRB. Philippe has previously obtained permission from the IRB for a clinical study of the therapeutic use of marijuana.
6. Two Women’s Entheogen Fund Awards Announced
Sandra Karpetas was awarded a $5000 grant from the Women’s Entheogen Fund, established at MAPS by an anonymous donor. Sandra won the award for her work with the Iboga Therapy House. Sylvia Thyssen was also awarded $5000 from the Women’s Entheogen Fund, for her work with Erowid and all she does for the psychedelic community.
7. LSD Conference in Basel, Switzerland
MAPS researchers and staff traveled to Basel, Switzerland in January, where we celebrated the 100th birthday of Albert Hofmann, the man who discovered LSD and first synthesized psilocybin. The Spirit of Basel hosted a symposium for the occasion, where MAPS brought several speakers to discuss topics related to psychedelic psychotherapy, including Drs. Michael Mithoefer, John Halpern, Andrew Sewell, Charles Grob, and MAPS staffers Rick Doblin and Valerie Mojeiko. MAPS associate Brandy Doyle also attended the conference and created several podcasts which can be downloaded from our website. The event received much media coverage, including feature stories on several local television stations in Switzerland and an article in the New York Times.
MAPS’ new edition of Albert Hofmann’s famous book, LSD: My Problem Child was available and for sale at the conference and is currently available from our online bookstore. MAPS also completed a Chinese translation which is available on our website along with a Russian and Polish translation. A Spanish edition is also available. MAPS is now exploring the idea of creating a Japanese edition.
8. Ayahuasca-Themed Issue of the Journal of Psychoactive Drugs
As we await a decision from the US Supreme Court in the religious freedom case about whether the Uniao do Vegetal (UDV) will be able to use ayahuasca legally in the US in its religious ceremonies, a special themed issue of the Journal of Psychoactive Drugs, “Ayahuasca Use in Cross-Cultural Perspective,” has recently been published. Edited by Marlene Dobkin de Rios, Ph.D., and Charles S. Grob, M.D., this 120-page journal covers a spectrum of current developments in ayahuasca use and research, including articles based on qualitative, neuropsychological and psychiatric assessments. Use of ayahuasca as a sacrament by the UDV and other groups is explored, as is the phenomenon of “drug tourism.” This special theme issue, volume 37, number 2, is available from Haight Ashbury Publications for $25 plus shipping. Please call 415 565 l904 or email .(JavaScript must be enabled to view this email address).
9. Merchandise Available at MAPS
We have an exciting line of limited availability merchandise to offer including:
Hofmann-signed prints by Alex Grey–
Visionary artist Alex Grey was recently commissioned to paint a portrait of Albert Hofmann, with the intention of creating an edition of 50 prints, each 16″ x 20″, numbered and signed by both Alex Grey and Albert Hofmann. 50% of the profit from the sales of these prints are going toward funding MAPS-sponsored LSD and Psilocybin research and for promoting Albert’s writings (such as translating LSD-My Problem Child into Chinese). The other 50% is going toward the Chapel of Sacred Mirrors, Alex and Allyson Grey’s temple which houses all of the Sacred Mirrors as well as other examples of Alex’s most transformative works of art. There were only 50 of these available, and only one is left for sale, numbered 1/50. We will be auctioning it on ebay and will announce in next month’s email update when the auction will begin.
Hofmann-, Huxley-, and Shulgin-signed prints by Dean Chamberlain–
We have sold all 50 of the original Hofmann-signed light painting prints by artist Dean Chamberlain, and are pleased to announce that we are now offering 25 larger versions of this same print (22 x 28 on 30 x 36 heavyweight fine-art archival paper), also signed by Albert Hofmann. We still have 20 left. This edition of prints was created to help fund MAPS-sponsored LSD and psilocybin research, as well as to commemorate Albert’s 100th birthday. Prints numbered 1-5 were offered at $4000 each; 6-15 are still available for $5000; 16-20 will be $6000, and 21-25 will be $7000.
Also by Dean Chamberlain, we have available signed portraits of Laura Huxley, profits from which will go to research the use of psychedelics to ease the dying process, with the cost $1000 each for the first 10 (7 available); and signed portraits of Sasha and Ann Shulgin, profits from which will go to MDMA-psychotherapy research, with the cost $1000 each for the first 10 (8 available).
Signed Copies of LSD: My Problem Child
A limited number of hardcopies of LSD-My Problem Child signed by the author are available through MAPS for $250 each. They will be available in about a month. To be put on a list to reserve your copy, contact .(JavaScript must be enabled to view this email address).
Please visit our online store to browse our other exciting merchandise including psychedelic-inspired art by the Huichol, books, clothing, and more!
10. In Memoriam: Carla Higdon, MAPS staffer from 1995-2001
It is with great sadness that we report that Carla Higdon died in her sleep Sunday night, at age 42. Carla was a courageous woman with a warm and powerful spirit. She was a loving and compassionate friend. She grew up in North Carolina and combined her love of art and her love of children to be an art teacher in the public schools in Charlotte, NC. In 1995, Carla met Sylvia Thyssen and Rick Doblin who at that time were the only two MAPS staffers. Carla started volunteering for MAPS and also helped Rick and Lynne Doblin take care of their babies, as the whole Doblin family grew to love her. Carla eventually became MAPS’ third full-time staff person. In 1998, she and Sylvia moved the main MAPS office to Sarasota and created a home in what is now the MAPS house. Carla continued to work for MAPS until 2001. Carla increasingly felt called to live in California and finally moved there, where she felt close to her community. It was Carla who first conceived of honoring the work of women in entheogen research, resulting in the creation of the Women’s Entheogen Fund. She became its first recipient.
Carla’s ashes will be spread on Siesta Key in Sarasota, Florida, where she loved to walk on the beach.
Thanks for reading.
-Valerie Mojeiko
Program Director and Clinical Research Associate
MAPS