MAPS News – November 2008: Chicago gets MDMA research – Washington gets Vaporized Marijuana Protocol
Dear MAPS Members, Supporters, and Friends,
It’s the dawn of a new era.
We have a lot to celebrate as we welcome President Obama and the tolerant, visionary, and empathetic leadership he represents, and say good-bye to the narrow-minded, unilateral, arrogance that has carried the American banner for the last eight years.
I want to publicly congratulate supporters of the Marijuana Policy Project, including Executive Director Rob Kampia and MAPS Alumnus Troy Dayton, for their huge victories for marijuana decriminalization in Massachusetts and medical marijuana in Michigan. In both states, more people voted in favor of marijuana policy reform than voted for Obama!
Now that our fellow citizens have done their part to hand the government a huge mandate for a major paradigm shift, it’s now time for President Elect Obama and his administration to do their part to put science before politics when it comes to medical marijuana research (and a host of other issues as well). The DEA still needs to issue a final ruling in response to DEA Administrative Law Judge Bittner’s February 12, 2007 recommendation that Professor Lyle Craker be issued a license for a MAPS-sponsored medical marijuana production facility, thereby ending the National Institute of Drug Abuse (NIDA) monopoly on the supply of marijuana for federally approved research. We look forward with anticipation to the DEA doing the right thing under an Obama administration.
MAPS President Rick Doblin, PhD is working on a strategy to insure that MAPS-related issues are no longer bogged down by the DEA or NIDA under the new administration. You will see in this email update that we have quite a few things keeping MAPS staff and researchers hard at work to accomplish our long-term goals on your behalf.
Fundraising is always tough during a presidential election year, particularly this one. Now that political campaigns aren’t competing for your world-changing dollars, I encourage you to consider honoring the hope of a new era by making a generous gift to MAPS so that we can continue to work within the system to legitimize psychedelics and medical marijuana.
Thank you for your commitment to science and the value of altered states. The road ahead is long and there will be many obstacles. Thank you for joining us in greeting the exciting challenges of this new era with enthusiasm and passion.
Randolph Hencken, MA BS
MAPS Director of Communication
Here is what you will find in this month’s email update:
- MAPS Researcher Michael Mithoefer MD Presents MDMA/PTSD Findings to Scientific Community
- Canadian IRB Gives Conditional Approval To MDMA/PTSD Protocol
- One Step Closer To Buying Legal Marijuana For Vaporizer Study
- Just Two More Subjects Needed: Chronic Pain/Opioid/Vaporized Marijuana Study Ends January 9
- MAPS Board Of Directors Meets
- MDMA/PTSD Study With War Veterans In The Planning Stage
- MAPS Transfers $25,000 To Our Swiss LSD Study
- MAPS San Francisco Soiree Was Simply Sweet
- Call for Papers: The Society For The Anthropology Of Consciousness
* * * Dues-paying MAPS members are empowering staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase books, clothes, art, and other merchandise, visit: store.maps.org * * *
On Thursday, November 13, Michael Mithoefer MD, the principal investigator for our US study of MDMA-assisted psychotherapy in subjects with treatment-resistant posttraumatic stress disorder (PTSD), will give his first presentation of the data to the scientific community. Michael will present a poster with the key findings from his Phase II clinical trial at the International Society for Traumatic Stress Studies, (www.istss.org) 24th Annual Meeting, to be held in Chicago. ISTSS is the largest organization in the world for researchers and therapists working with PTSD patients.
In an effort to increase public awareness about our research we have drafted a press release to announce Michael’s poster presentation. Unfortunately, we are unable at this time to report the exact data presented in the poster because doing so might compromise our ability to get a paper about the data from the research published in a scientific journal. Scientific journals are reluctant to publish work that has previously been published elsewhere, though scientists can freely present their data to their peers at scientific conferences.
On Friday, November 7 the Canadian Institutional Review Board (IRB) granted conditional approval for our MDMA/PTSD protocol. The conditions are relatively easy to meet. We must have resuscitation equipment at the research clinic, confirm that study staff will possess previous practical experience with psychological distress, especially with respect to psychedelic drugs, and add a tool for the assessment of subjects’ suicidal risk (e.g., suicidal ideation) to provide a more structured evaluation. We are now selecting a preferred measure for assessing suicide risk. We are also now preparing documents to be submitted to Health Canada (Canada’s version of the FDA).
The IRB met on Wednesday, November 5 to review our replies to changes previously requested by the IRB. The IRB reviewed our responses and approved them. We replied to issues related to the open label stage of the protocol, the age of enrollment, and prior substance abuse history of subjects. The IRB agreed that we can retain the open label stage 2 portion of the protocol—the portion of the protocol in which everyone who was randomized to placebo in Stage 1 receives open label MDMA in the Stage 2. The inclusion of an open-label Stage 2 in our protocol has multiple purposes: 1) The therapist can better learn the contribution that MDMA itself plays in MDMA-assisted psychotherapy by treating patients who initially received placebo (psychotherapy without a full dose of MDMA); 2) It is scientifically valuable since subjects who receive placebo initially act as their own controls; 3) It helps with recruitment and retention of subjects, since subjects know that by participating in the study they will eventually get the opportunity to receive MDMA-assisted psychotherapy
We reached a compromise agreement with the IRB on the age of enrollment and prior substance abuse history. Subjects must be 21 years old to enter the treatment and cannot have abused drugs during the six months leading up the treatment. We also shortened the length of the informed consent form, as requested. Our success with the Canadian IRB is an important milestone in our march toward the globalization of MDMA/PTSD research.
On November 6, 2008, Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol (PDF) to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers.
We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research.
The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study–which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA.
Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. We’ve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.
We are optimistic that the incoming Obama administration will allow science to prevail over ideology, thus allowing us to conduct medical marijuana research with fewer roadblocks. As it stands now, our vaporizer protocol has been repeatedly impeded and we are virtually the only people in America who, after more than five years of trying, remain unable to purchase 10 grams of marijuana!
Dr. Donald Abrams’ National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are using opioid medications for pain ends January 9th and two subjects are still needed! This is the only medical marijuana study with human subjects currently taking place in the U.S. We had previously reported that there were two medical marijuana studies with human subjects taking place in the U.S. However the study that was being conducted by the Multiple Sclerosis Society at UC Davis has changed locations and has been held up for the last several months waiting on the DEA to reissue a license for the new location.
It is urgent that Dr. Abrams’ study enrolls the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study.
MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University.
Thanks to our supporters and friends who helped us enroll many subjects this past month!
On October 21, MAPS’ Board of Directors met in San Jose, California. The board reviewed our financial record from fiscal year 2007-08, as well as our accomplishments and upcoming goals. Our in-house accountant Josh Sonstroem attended the meeting to present our financial records and budgets. At the conclusion of the meeting, Board Members John Gilmore and Ashawna Hailey each committed $150,000 for the upcoming fiscal year 2008-09.
We are very grateful for John and Ashawna’s continued support financially and for their insightful, intuitive, and forward-thinking contributions to our strategic planning.
The European Medicines Agency has recently issued guidelines for sponsors interested in developing drugs to treat PTSD. The PTSD guidelines suggest that research be conducted in subgroups of people with PTSD, grouped according to the cause of their PTSD, for example, sexual assault or war-related PTSD. The purpose of such research is to identify if PTSD that is caused by a different type of trauma (i.e. sexual assault, war) responds to a specific treatment with similar or different success rates. If the treatment appears to have similar efficacy across subgroups, then people with PTSD from different causes can be enrolled in the same Phase 3 study but if the treatment is different, the Phase 3 studies should each be in a homogenous group of subjects by cause of PTSD.
As a result of the EMEA guidelines, MAPS, Michael Mithoefer MD, and Annie Mithoefer BSN will soon start the design and approval process for a new study investigating subjects whose PTSD is a result of war trauma. This study will include seven veterans, four women and three men, so that we can also gather some preliminary information on possible gender differences in response to MDMA-assisted psychotherapy.
Principal Investigator Peter Gasser MD has enrolled 4 patients in his Swiss LSD/end-of-life anxiety study. On November 3, the second of the patients had an LSD session. On Friday, November 7, MAPS transferred $25,000 to the Swiss bank account of the Swiss Medical Association for Psycholytic Therapy (SAEPT), with the funds restricted to the Swiss LSD end-of-life anxiety study. We would like to thank Robert Barnhart for his continued and generous support for this research.
The study’s budget is $225,000, we have already raised about $125,000. We are still seeking the final donations of $100,000.
On October 11th, MAPS hosted a Soiree in San Francisco, which completely sold out. We wish to publicly thank Jim Siegel for welcoming us into his home (the William Westerfeld House). We are also grateful to all of our speakers, performers, DJs, and volunteers, some of who traveled a considerable distance to appear at the party. These people include Ralph Metzner, Anjuli Verma, David Jay Brown, Tucker Teutsch 3.0, Shrine, T.W. Monk, Mr. Projectile, Spacetime Continuum, Lunacy, and Epic Chocolate!
We were very pleased with the kind-hearted spirit of all of those who attended. Jim Siegel appreciated our community so much that he has invited us back next year. We have tossed around a few ideas, and we will let you know when we are ready to have a party that is somehow or other even a bit better!
Our friends at the Association for Transpersonal Psychology are now an official Co-Sponsor of the Society for the Anthropology of Consciousness’s conference, “Bridging Nature & Human Nature.” The conference in Portland, Oregon will be held April 1-5, 2009.
The organization is seeking papers on “Entheogens and the Legacy of Albert Hofmann.”
Conference information is available at www.sacaaa.org
You should also visit MAPS on youtube and myspace.
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