Transforming psychedelics into legal medicines takes a lot of work. In the last few newsletters, we've explored how our international clinical research program is growing fast and getting great results.
Meanwhile, MAPS is helping the world imagine what will happen when people suffering from PTSD, end-of-life anxiety, and other conditions have access to the healing potential of these powerful tools. As part of our ongoing efforts to educate people about the real risks and benefits of psychedelics, we've launched a new educational website with clear, in-depth information about MDMA-assisted psychotherapy for PTSD.
Share www.mdmaptsd.org with your family, friends, and colleagues and help make this much-needed treatment a reality.
Here's just a sample of what else is new this month:
Our new study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado, is in the final stages of approval. The study will be our second-ever U.S. trial site and help train a new generation of therapists.
The DEA responds to Prof. Lyle Craker's federal lawsuit against the agency for refusing to let him grow marijuana for federally regulated research.
From April 8-11, 2012, the therapist teams for our MDMA-assisted psychotherapy for PTSD "intern" study completed therapist training in Charleston, South Carolina, with MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. The new intern study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The intern study will take place in Boulder, Colorado, and will be our second clinical trial site in the United States.
On March 27, the study protocol was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27. This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA.
On March 9, the protocol received approval from the Institutional Review Board, conditional on the pending approval of the study physician's Schedule I license. The day before, on March 8, the IRB had requested several changes to the subject informed consent documents. MAPS' clinical team made the changes, resubmitted the documents, and obtained approval in less than 24 hours. The study initiation meeting will be scheduled once the DEA approves the study physician's license application, which was submitted on March 6. The DEA has no time limit on its response, but we are hopeful that we will be able to begin the study before the summer.
On March 27, 2012, reviewers for a scientific journal responded with their comments on the paper describing the results of our long-term follow-up of subjects who participated in our initial U.S. proof of principle study of MDMA-assisted psychotherapy for PTSD. In their comments and feedback, all four reviewers concluded that it was a strong paper that substantially contributed to the existing scientific research on MDMA-assisted psychotherapy for PTSD. We have incorporated the reviewers' feedback into the paper, which will be resubmitted for publication in the next few days.
The study, conducted by lead investigator Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., found that the benefits of MDMA-assisted psychotherapy for PTSD persisted for an average of 3½ years after the last treatment. The study found no evidence of harm associated with the administration of MDMA, either immediately following treatment or during the long-term follow-up. These results are even more important than the remarkable results of our initial proof of principle of study as measured at the two-month follow-up, confirming that the benefits of MDMA-assisted psychotherapy persist over time.
On March 20, 2012, the seventh subject out of 24 was enrolled in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. This study, led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., will enroll 24 U.S. veterans suffering from chronic, treatment-resistant PTSD occurring as a result of war-related PTSD.
On March 19-23, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., completed a monitoring visit at the site to ensure data accuracy and compliance with Good Clinical Practice (GCP) guidelines.
On February 22, 2012, an Australian ethics committee rejected the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The committee raised issues relating to study design that MAPS and the Australian research team believe can be successfully addressed, and that in some cases represented misunderstandings on the part of the reviewers. MAPS and the Australian psychedelic research group Psychedelic Research in Science and Medicine (PRISM) are now preparing a reply. We are hopeful that a version of the protocol can eventually be approved.
On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker's lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA's rejection of DEA Administrative Law Judge Bittner's recommendation (PDF) that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research.
In their response brief, DEA lawyers (1) argued that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) moved to strike parts of our argument based on NIDA's September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterated previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license. Prof. Craker's lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker's legal team will be submitted in early May. Oral arguments will likely take place in Boston in May or June 2012.
On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study.
In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study.
As of April 6, 2012, seven out 30 subjects had completed follow-up in our ongoing observational study of ibogaine treatment for addiction in Mexico. Nineteen out of 30 subjects are still in the follow-up portion of the study, which entails one year of evaluations for addiction and quality of life following treatment at an independent ibogaine treatment center in Mexico. Data from this study will be compared with data from our recently approved observational ibogaine study in New Zealand.
For the latest psychedelic and medical marijuana research news, visit MAPS in the Media.
Learn from the experts about the latest breakthroughs and challenges in medical marijuana research and activism. The Science and Politics of Medical Marijuana all-day pre-conference workshop took place on December 9, 2011, as part of Cartographie Psychedelica, MAPS' 25th anniversary conference and celebration. The workshop included top researchers and activists, including Donald Abrams, M.D. (UCSF), Lyle Craker, Ph.D. (UMass-Amherst), Sue Sisley, M.D. (University of Arizona), Martin Lee (Project CBD), Clint Werner (author, Marijuana: Gateway to Health), Fred Gardner (O'Shaugnessy's), Amanda Reiman (Berkeley Patients Group), Dale Gieringer, Ph.D. (NORML), Debby Goldsberry (United Cannabis Collective), and Steph Sherer (ASA), and was moderated by Allen Hopper, J.D. (ACLU).
On March 25, 2012, MAPS Founder and Executive Director Rick Doblin, Ph.D., gave a keynote speech about psychedelics, drug policy, and social change at the 2012 Students for Sensible Drug Policy Conference in Denver, Colorado. He received a standing ovation for his talk, which addressed how the responsible use of psychedelics can help promote positive social change. Watch the short version here (21 minutes):
Since our announcement in last month's newsletter, the rousing debate on the risks and benefits of MDMA that took place at the 2011 Breaking Convention conference has received over 1,300 views. The fascinating debate between top scientific experts addressed many issues not commonly addressed in the scientific literature or popular press. The full transcript of the debate is available here (PDF).
Norwegian researcher Teri Krebs explains to BBC World News how her recent meta-analysis with Pal-Orjan Johansen from several studies of LSD treatment for alcoholism from decades ago showed that LSD given to alcoholics produced beneficial effects that diminished alcohol abuse for up to six months after a single dose. The meta-analysis was published in the Journal of Psychopharmacology (PDF).
On Friday, April 6, MAPS hosted an evening of art, music, and conversations about psychedelic science and medicine at our Santa Cruz, California headquarters. Professor James Fadiman, Ph.D., author of the Psychedelic Explorer's Guide and co-founder of the Institute for Transpersonal Psychology, led an informative yet casual discussion about psychedelic research and creativity studies, and assessed the uses of psychedelics in therapeutic and clinical settings.
We displayed the work of six young artists who support our work by offering their art for sale at our events and online store. Visitors enjoyed live music performances by Cello Joe and Homunculus Rex, plus Balinese dance by Annika Johnson and belly dance by San Francisco-based Hasna Hip Flow. Special thanks go to MAPS intern Bryce Montgomery for filming and editing this video.
Visionary individuals and family foundations fund all of MAPS' research and educational projects. MAPS deeply thanks the following for supporting this important work last month:
Richard Wolfe for $5,000 to support ayahuasca programming at next year's conference.
An anonymous donor for $12,500 for our upcoming "intern" study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado.
In addition, MAPS received 231 gifts in March for a total of $7,748, ranging from $5 to $300. Many of these smaller gifts were made easily and securely through automatic monthly payments. We would especially like to thank all the students who signed up for the monthly option at the 2012 Students for Sensible Drug Policy Conference in Colorado! If you would like to join these donors, call 1 (831) 624-6362 or visit maps.org/donate.
Includes contributions and insights from MAPS founder Rick Doblin, Albert Hofmann, Stanislav Grof, Alexander Shulgin, and many others about the potential of psychedelics as tools for spiritual development, and precautions for their use.
Learn about the rediscovery of MDMA by Dr. Alexander Shulgin in this informative, entertaining, humorous, sincere, and heartfelt documentary. Order your copy today to support MAPS' ongoing MDMA research.
Visit our online art gallery to view works by Adam Scott Miller, Alex Grey, Dean Chamberlain, A. Andrew Gonzalez, Simon Haiduk, Autumn Skye Morrison, Michael Divine, and many more. Buy a masterpiece today and help further the psychedelic research renaissance!
From April 13-28, 2012, you can get 25% off all artwork purchases from Threyda.com while supporting MAPS! Visit Threyda's breathtaking art gallery to browse works by Peter Westermann, Fernando Chamarelli, Simon Haiduk, Fabián Jiménez, Cody Seekins, and more. Use discount code MAPS419 to receive a 25% discount on artwork purchases and also trigger a 25% donation to MAPS! This fundraiser is for a limited time only.
If you're curious about why Threyda supports MAPS' efforts to study the healing potential of psychedelics and cannabis, read "Why MAPS Matters" by Threyda founder Peter Westermann.
Don't forget to visit our Events Calendar for more events at the intersection of science, art, and medicine.
Gary Fisher, a pioneer researcher during the early days of psychedelic exploration, died on March 2, 2012, at the age of 80 years. During the late 1950s and early 1960s, Fisher explored the use of psychedelic drugs in autistic and schizophrenic children. He subsequently examined the role of psychedelic treatment in adults with major mental illness and in patients with terminal cancer. He was a gifted writer, and contributed a number of valuable articles to the professional literature. MAPS readers may be familiar with his final two publications, which appeared in the MAPS Bulletin: "Treatment of Childhood Schizophrenia Utilizing LSD and Psilocybin" (Summer 1997, available online) and "Successful Outcome of a Single LSD Treatment in a Chronically Dysfunctional Man" (Summer 1999, available online).
Fisher was born in Winnipeg, Manitoba, Canada and received his Bachelor's degree at the University of Manitoba and doctoral degree in research psychology at the University of Utah. He held faculty positions in the Department of International Relations at the University of Hawaii and in the Department of International Health Education at the University of California at Los Angeles School of Medicine. Fisher was first exposed to psychedelics and their potential in psychiatric treatment through his brother-in-law, Nicholas Chwelos, a collaborator of Humphrey Osmond and Abram Hoffer in Saskatchewan, Canada. Fisher was also an early associate of Timothy Leary, and accompanied him through his travels in Mexico and the Caribbean, and at Millbrook in New York. He was also a close friend and confidante of Laura Huxley.
Fisher was a great friend and mentor to many contemporary psychedelic researchers, and played a vital behind-the-scenes role in helping to launch the current generation of psychedelic research. He had a unique outlook on life, happiness, and the potential of psychedelics as adjuncts to psychotherapy. He was also a talented artist with a generous and compassionate soul. He leaves behind his three daughters and many grandchildren.
In late 2010, Alexander "Sasha" Shulgin, discoverer of the therapeutic properties of MDMA and hundreds of novel psychoactive chemicals, suffered a stroke. Although he has been recovering since this time, the Shulgins are struggling against a tide of medical and care bills. Sasha continues to face a variety of age-related health challenges. Despite Sasha's important work in the laboratory, the Shulgins have received very little monetary gain from their endeavors. Funds raised from the auction of these limited artifacts of psychedelic history will help an elderly couple that together has transformed psychedelic science in a way that no fundraiser can ever repay. Click here to learn more.