Newsletter: November 22, 2004

This pilot study is designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. The study will be conducted by principal investigator Dr. John Halpern, and co-investigators Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel.

The two IRBs responsible for evaluating the MAPS-sponsored protocol have each approved the protocol (the protocol is posted at , in the clinical research section at the top.)

Harvard Medical School’s McLean Hospital IRB approved the protocol on October 27, 2004 (subject to FDA and DEA approval), and requested that the informed consent form be shortened. On November 10, the McLean IRB approved the shortened consent form. McLean Hospital is where the psychotherapy and experimental sessions will take place.

Also on November 10, the Lahey Clinic Institutional Review Board (IRB) approved the study. Lahey Clinic is where Dr. Todd Shuster, the study oncologist, works and is the place from which the subjects will be recruited.

On November 19, 2004, the protocol and associated documents were submitted to FDA. FDA should receive the protocol Monday, November 22 and will have 30 days from that point to review the protocol and approve, reject or place it on clinical hold pending resolution of any issues FDA felt it appropriate to raise.

If approved by FDA, the last remaining hurdle before the study can start will be Dr. Halpern’s need to obtain a DEA Schedule 1 license. Due to the compelling nature of this study and the degree of existing support, we feel confident that DEA will issue the license sooner rather than later, most likely voluntarily.

When finally fully approved, this study will be the first psychedelic research to take place at Harvard since 1965.

With the MDMA/anxiety study protocol submitted to the FDA, MAPS is beginning to focus on developing the next Harvard study, in which LSD and psilocybin are explored as a treatment for cluster headaches. On October 22, 2004, Patient advocates, researchers, and donors met at Harvard Medical Schools McLean Hospital to discuss the development of the LSD/psilocybin cluster headache study. At the meeting, Dr. Andrew Sewell discussed his review of the 100+ case reports of people who have tried the LSD and/or psilocybin treatment, which he and Dr. John Halpern will turn into a paper for publication. This will in turn support the study protocol that MAPS will submit to the FDA, hopefully early next year. On November 10, 2004, the McLean IRB approved a questionnaire study that Drs. Sewell and Halpern will use to further support the protocol.

Cluster headaches are unbelievably painful, and people often get them in cycles that make their lives very difficult. About a year ago, Bob Wald, a cluster headache patient advocate contacted MAPS seeking assistance in conducting formal research to investigate what patients had already discovered on their own, that LSD and psilocybin can help some subset of patients to break the cycle of cluster headaches and delay or prevent the recurrence of new cycles, far more effectively than the drugs available by prescription.

The study investigating the LSD and psilocybin treatment will cost an estimated $150,000 budget, of which we already have $50,000, donated by Marsha and David Weil. On October 25, 2004, MAPS donated $10,000 of this money to McLean Hospital for work by Dr. John Halpern and Dr. Andrew Sewell on the publication of the case reports and on the protocol design and approval process.

At present, there isn’t any legal research with LSD taking place anywhere in the world. It’s our goal to get this study approved while Albert Hofmann is still alive to see the resumption of research with LSD. In early November, Rick Doblin wrote to Dr. Hofmann to tell him about the cluster headache project. He wrote back to say, “I learned with interest that MAPS is slowly transforming itself into a non-profit psychedelic and medical marijuana pharmaceutical company with the mission to transform these drugs into approved prescription medicines. What a beautiful, high goal!”

At the request of our Institutional Review Board (IRB), MAPS has established a Data Safety Monitoring Board (DSMB) that works for MAPS reviewing the data from Dr. Mithoefer’s MDMA/PTSD study on an ongoing basis. The DSMB met on November 15 to review the charts from the first five subjects who have completed their final follow-up evaluation, which takes place two months after the second experimental session. The DSM concluded that “We did not see any significant adverse events that caused us any concerns about the safety of this study.” They recommended that “the study continue without modification.” The next scheduled meeting of the DSMB will take place after the next five subjects (the 6th-10th) have completed their final follow-up evaluations. The DSMB will also meet if there is a serious adverse event.

Though only five of the intended twenty subjects have completed the study, we’re cautiously optimistic about the outcome.

As a result of a Freedom of Information Act (FOIA) request made earlier this year, MAPS now has information on National Institute on Drug Abuse (NIDA) funding awarded to Dr. George Ricaurte and Dr. Una McCann in 2003 for the study of MDMA (Ecstasy) neurotoxicity and functional consequences of Ecstasy use. The pair of Johns Hopkins researchers were awarded over $1.8 million dollars during 2003. This brings their total government funding to more than $16.4 million since 1989. Go to to learn more.

We are pleased to report that the Marijuana Policy Project (MPP) has approved MAPS’ grant request of $30,000 in full. That’s $18,000 for MAPS’ operational expenses for staff work on medical marijuana-related projects, $6,000 for legal expenses for the DEA/HHS lawsuits and Supreme Court amicus curiae brief, and $6,000 to donate to UMass Amherst for use by Prof. Lyle Craker for his efforts to obtain a license for a MAPS-sponsored medical marijuana production facility.

An anonymous family foundation has continued their support of MAPS and MDMA research with a new $30,000 donation for MDMA psychotherapy research.

A new donor generously donated $35,000, through a fund at the Tides Foundation, for MAPS operational expenses. Because most large donations are earmarked for specific research projects, donations for operational expenses are especially appreciated, so we can continue to do the work of building MAPS as an organization and a source of information and education.

MAPS is hosting an online benefit auction next month, with a fantastic collection of donated items. We will send out details on the dates as soon as we have it. Paintings, a handmade painted glass chandelier, signed books, a week in a vacation house in France, and much more will be available. There will be a site advertising these items up online very soon. Stay tuned! Meanwhile, if you have any items you’d like to donate to the auction, please contact me at .(JavaScript must be enabled to view this email address).

We have reprinted two MAPS-published books that have sold out, The Secret Chief by Myron Stolaroff and Ketamine: Dreams and Realities by Karl Jansen. The new edition of The Secret Chief is called The Secret Chief Revealed, because this edition reveals the identity of the underground psychotherapist, Leo Zeff, whose story is told. Leo Zeff worked with hundreds of people during his lifetime, and this new edition includes more testimonials from clients, new ones from his family, and photos. This book is in stock and available on the MAPS website.

Ketamine: Dreams and Realities is also being reprinted, and we expect it to be available for purchase by the end of the year. The new edition features a new preface by the author discussing the developments in ketamine use and research over the past five years.

Myron Stoloroff, author of The Secret Chief and pioneering psychedelic researcher, has generously allowed MAPS to make his book “From Thanatos to Eros: 35 Years of Psychedelic Research” available free on the MAPS website. Quoting briefly from the Forward by Alexander Shulgin and Ann Shulgin:

“The story of Thanatos to Eros takes us through two marriages, over the course of the author’s growth from a successful engineer to an independent business man, and eventually, we see his first steps and subsequent strides as a researcher and explorer of human consciousness. We move with him through the often intense and difficult changes that take place as he learns to use his chosen tools, the psychedelic drugs, beginning with LSD in 1956, and progressing to other powerful visionary plants and drugs over the subsequent years. He is trying to, in the words of Carl Jung, “make the unconscious conscious,” as the way to attain realization of his ultimate self. We discover, along with him, that this is a hard goal to attain, and that it must be sought with complete inner integrity and fearless self-examination.”