* Read the May 2010 MAPS Email Newsletter in the MAPS email news archive *
Marijuana/PTSD Protocol Drafted; MAPS Tries Again to Overcome PHS/NIDA Obstacles
We’ve completed the initial draft of a MAPS-sponsored marijuana/PTSD protocol, designed as a pilot study to investigate whether medical marijuana might be a safe and efficacious treatment for PTSD. We plan to refine the protocol and submit it to the FDA in the next four to eight weeks. Sue Sisley, M.D., will lead the study, planned to take place near Phoenix, Arizona. The study is titled "Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of Smoked or Vaporized Cannabis in 32 Veterans with PTSD.” Sasha Stafford, B.S., joined us to help create the first draft this protocol. Stafford earned his B.S. in chemistry, has worked in regulatory affairs and clinical research, and is the son of Psychedelic Encyclopedia author Peter Stafford.
The need for scientific research into the risks and benefits of medical marijuana use is urgent, as evidenced by NPR’s broadcast this past week about the use of marijuana to treat symptoms of PTSD. But there continue to be major obstacles to FDA drug development research with marijuana that MAPS has been trying unsuccessfully for almost a decade to overcome. The primary obstacle is that the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana for use in clinical research and uses that monopoly to obstruct privately funded studies into the potential beneficial uses of marijuana.
With more and more states voting to legalize marijuana as a medicine, medical professionals are increasingly searching for clinical studies to draw upon when choosing whether or not to recommend marijuana as a treatment.
We anticipate that we will eventually be able to obtain FDA and IRB approval for our protocol. Realistically, based on statements by NIDA official Steven Gust, Ph.D., we expect that the NIDA/Public Health Services (PHS) review process will take at least a year (as compared to FDA’s 30-day review process), and probably much longer. The initial response from PHS/NIDA is supposed to take six months, but we’ve seen past instances where it has taken years. Since it is inevitable that there will be some critiques of some aspects of the protocol, the PHS/NIDA review process for our response will likely take at least another 6 months. This time delay is outrageous. MAPS fears that the NIDA/PHS review will result in the protocol being rejected, even though we are not asking for a penny of federal money and are seeking to purchase NIDA marijuana at cost. Hopefully our dim view of the politically required and totally unnecessary PHS/NIDA protocol review process will be disproven, perhaps due to sympathy for veterans and also to the negative publicity NIDA would receive if the protocol is rejected.
Our study is designed as a four-arm study. Three groups will receive NIDA marijuana with 2%, 6% or 12% THC. The fourth group will receive marijuana that is about 6% THC and 7% CBD, since we would like to compare and contrast the effects of marijuana with THC with marijuana with THC and CBD, which has been reported to have anti-anxiety properties. NIDA has no marijuana available with any significant levels of CBD, but claims to be able to provide whatever researchers request. The U.K. Company GW Pharmaceuticals manufactures a marijuana extract administered under the tongue, Sativex, which is 50% THC and 50% CBD. Bedrocan in the Netherlands has a plant strain that is 6% THC and 7% CBD, but their product is not yet approved by FDA for use in clinical research, though Bedrocan is seeking to obtain approval from FDA for use of its marijuana in U.S. clinical trials.
If NIDA were sincerely interested in facilitating medical marijuana research, it would already have asked Dr. ElSohly (a professor at the University of Mississippi who is the only person in the U.S. licensed to grow marijuana for research under contract to NIDA) to produce a strain of marijuana with substantial levels of CBD as well as THC. Rather, Dr. ElSohly claims that no researcher has ever requested marijuana with CBD, and has therefore not produced any. Whether NIDA will order Dr. ElSohly to produce a strain of marijuana that is 6% THC and 7% CBD for our proposed study is anybody’s guess. Even if NIDA does request it, how long it will take for Dr. ElSohly to create such a strain and have it approved by FDA for use in clinical research is also anybody’s guess. It’s been 28 years since the first paper indexed in medline showed that CBD has anti-anxiety properties (Psychopharmacology (Berl). 1982;76(3):245-50. Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal subjects. Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG.) The fact that NIDA still doesn’t have a strain with significant amounts of CBD shows that NIDA is not proactively seeking to facilitate medical marijuana research, yet another reason why the NIDA monopoly needs to end.
NIDA’s monopoly fundamentally obstructs medical marijuana research. We are aware of no privately-funded medical marijuana research in the U.S. in over 40 years. It doesn’t make sense to spend money on research for which the sponsor doesn’t have control over price, availability, and content of the marijuana strains to be tested and perhaps eventually brought to market. Dr. ElSohly is the only person authorized by DEA to grow marijuana for research and has massive and obvious conflicts of interest against seeing more marijuana plant products become available as medicines. Dr. ElSohly has financial interests in generic Marinol made by Mallinckrodt from THC which Dr. ElSohly extracts from marijuana he and he alone has permission to grow for medical purposes, and for his own personal financial gain.
MAPS is going ahead with our marijuana/PTSD protocol design and approval process because of the pressing social interest in finding new treatments for vets with PTSD. In addition, since we are already sponsoring MDMA/PTSD research, we can learn a great deal more about treating PTSD if we also initiate a marijuana/PTSD study.
In February 2007, DEA Administrative Law Judge Mary Ellen Bittner ruled that it is in the public interest for the DEA to license Prof. Lyle Craker, UMass Amherst, to grow marijuana under contract to MAPS, ending NIDA’s monopoly. The DEA has tried to reject Bittner’s recommendation, but we have filed a Motion to Reconsider to which DEA has not yet responded, following its long and successful strategy of delay. The Senate confirmation hearing of Michele Leonhart, to be Administrator of the DEA has not yet been scheduled. She signed the order overruling Bittner’s recommendation and led the DEA’s efforts to arrest medical marijuana patients and providers in medical marijuana states, yet was still nominated by Pres. Obama. We’re working to have her questioned by Senators on the Judiciary Committee about the DEA’s rejection of the ALJ recommendation.
Meanwhile, U.S. vets with PTSD are increasingly using marijuana to treat PTSD without any scientific research on that use. MAPS will do its best to try to bring some science to bear on marijuana for PTSD, even with the obstacles placed in the way by the NIDA monopoly and the PHS/NIDA protocol review process that exists for marijuana but for no other drug. Perhaps the PHS/NIDA reviewers will pay attention to the words of U.S. Secretary of Defense Robert Gates, who stated during a recent appearance at a gathering of mental health professionals on October 26, 2009, “Beyond waging the wars we are in, treatment of our wounded, their continuing care, and eventual reintegration into everyday life is my highest priority, … I consider this a solemn pact between those who have suffered and the nation that owes them its eternal gratitude."
Our study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans of war is waiting for the FDA’s Controlled Substances Staff (CSS) to complete its review of the qualifications of the investigator (Michael Mithoefer, M.D.) and to evaluate the protocol from a diversion control perspective. Since Dr. Mithoefer held a DEA Schedule 1 license for our flagship MDMA/PTSD study and conducted an excellent study with all MDMA properly accounted for, the review by the CSS will almost certainly be favorable. Unfortunately, there is no time limit on how long the CSS can take to review protocols, so we can only wait for CSS to focus on our study. After the CSS approves the investigator and protocol, then the DEA must renew the Schedule 1 license of MAPS’ lead investigator Michael Mithoefer, M.D. and give him permission to order more MDMA for the new study. We hope to start this study soon.
U.S. MDMA/PTSD Paper Revised and Resubmitted; Long-Term Follow-Up Study Continues
On Sunday May 9, a manuscript about our flagship U.S. MDMA/PTSD pilot study was resubmitted to a peer-reviewed journal after receiving initial responses to the original submission from four reviewers. We should learn in the next several weeks if this version of the paper, or a slightly modified version, will be accepted for publication. If so, it will be cause for major celebration since this would become the first published paper about a completed study of MDMA-assisted psychotherapy for PTSD. The authors of the paper include Principal Investigator Michael Mithoefer M.D., Mark Wagner, Ph.D., Annie Mithoefer B.S.N., Ilsa Jerome, Ph.D. and Rick Doblin, Ph.D. While our drug development effort does not require the publication of the results of our research in peer-reviewed scientific journals, our public education efforts will be greatly enhanced if we can manage to publish our results.
The long-term follow-up study for this research project is still ongoing, with just a few additional subjects still to be assessed. The remaining data on long-term effects of MDMA-assisted psychotherapy to be collected from the subjects is extremely valuable to the final data analysis and submission to the FDA. Preliminary results from the long-term follow-up are encouraging.
Health Canada Official to Meet With MDMA/PTSD Researcher Ingrid Pacey, M.D.
An official with Health Canada is working to schedule a meeting in June with MAPS-sponsored researcher and Principle Investigator Ingrid Pacey M.D., to discuss the remaining issues in the authorization process for our MDMA/PTSD study. Frustratingly, our research project in Vancouver, with co-therapists Pacey and Andrew Feldmar, M.A., has been on hold since March 2009, when Dr. Pacey filed for her authorization to administer the MDMA. We had been under the impression that our application to import the MDMA for the study was ready to be approved since we had obtained approval of the protocol from a Canadian Institutional Review Board (IRB) and Health Canada. However, Dr. Pacey heard nothing for many months and then, in November 2009, was informed that before she could be authorized to administer the MDMA and before we could apply for a permit to import MDMA, we needed to obtain affiliation with a Canadian institution. In February 2010, Dr. Pacey obtained institutional affiliation, and in March 2010, she notified Health Canada of this affiliation, again hearing nothing for several months. We are hoping this upcoming meeting with Health Canada will clearly outline the remaining steps we must take before the MDMA can be imported and the study can begin. While it has been discouraging to have waited over a year since the protocol itself was fully approved, we are hopeful that Health Canada will move forward with our effort to start the first psychedelic research project in Canada in over 35 years.
Switzerland MDMA/PTSD One-Year Follow-Up Study Proceeds
The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase. The experiential portion of the study was completed in January 2010. Six subjects have completed the long-term follow-up, one subject has withdrawn from the long-term follow-up, and five subjects are yet to complete this portion of the study.
MAPS has built a new database to store the data for this study and the database has been verified for accuracy. We are now recruiting an intern or two to assist with data entry from this study. We will be choosing interns amongst applicants who pass stringent tests of accuracy in data entry. Katharina Kirchner, M.A. who is assisting our Swiss LSD/end-of-life anxiety study, will also be assisting the investigators of this study with data entry and data clean up. We anticipate that the data entry will take two months to complete, with additional time required to ensure accuracy of data in the database. The final analysis won’t be completed until the study ends at the beginning of 2011.
Second MDMA/PTSD Therapist Training Program, Soliciting More Applicants
From April 7 to 12, Michael Mithoefer, M.D., and Annie Mithoefer B.S.N. led an MDMA/PTSD therapist-training program with eight attendees in South Carolina. The group reviewed our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was reviewing videos from past experimental psychotherapy sessions from our first U.S. MDMA/PTSD study. This training program, and those planned for the future, will be used to teach applicants to conduct our future research projects. Applicants who complete the non-drug training program and satisfy screening criteria may have the opportunity to take MDMA in a therapeutic setting as part of our Phase 1 study to investigate the effects of MDMA on healthy volunteers; this study is also designed to give therapists subjective experiences of what MDMA therapy is like.
We are anticipating that we will need more therapist teams in approximately three years, if and when we start our Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. If interested please contact Berra Yazar-Klosinski, Ph.D. at: berra@maps.org
Jordanian MDMA/PTSD Team Participates in Training Program/Conference
Our Jordanian MDMA/PTSD team, led by Nasser Shuriquie, M.D., participated in a six-day therapist-training program conducted by Michael Mithoefer, M.D. and Annie Mithoefer B.S.N. in Charleston, South Carolina. The Jordanian team, which included Tayseer Shawash, Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social worker Rudiana Abubaker, then traveled to San Jose to attend our conference, Psychedelic Science in the 21st Century.
Our clinical research team has drafted a second amendment to the protocol for our Jordanian MDMA/PTSD study. The new amendment increases collection of safety information. We will send this amendment to the Jordanian IRB in the coming weeks.
Amendment to LSD Protocol Submitted to Swiss Ethics Committee
On May 4, 2010, Peter Gasser, M.D. submitted an amendment to our Swiss LSD/end-of-life anxiety study to his Ethics Committee (EC). The EC will meet on May 25 to evaluate the amendment. The amendment requests that we 1) include audio and video recording of the treatment sessions for later analysis, 2) add interim data analysis in order to get a sense of the safety and effectiveness of treatments before the study is over, and 3) make the protocol more flexible to meet the needs of the study population, which are people with advanced-stage cancer or other life-threatening diseases. Often these subjects have difficulties leaving home because of pain. As a result, we would like to expand some of the timelines in the current version of the protocol in order to be more flexible with the subjects.
Currently, the eighth subject out of 12 has been enrolled, with the eighth subject’s experimental treatment to take place soon. We are also adding a new clinical study assistant to the staff, Katharina Kirchner, M.A. of Switzerland. She will assist with data entry for this study and for our Swiss MDMA/PTSD study.
New Ibogaine Study Under Development
The MAPS clinical research team met during our Psychedelic Science in the 21st Century conference to develop a new ibogaine outcome study. Principal Investigator Valerie Mojeiko and co-investigator Tom Kingsley Brown, Ph.D., will lead the new study. They will collect data from patients who undergo ibogaine treatment for opiate addiction at Pangea Biomedics in Tijuana, Mexico, in order to evaluate the long-term changes that follow ibogaine treatment. The team discussed details of the new protocol, one of which will add random urine tests as another assessment technique.
The previous ibogaine study sponsored by MAPS and led by John Harrison has ended, and we are currently evaluating the data. We are applying insights from our initial study to the design of the new protocol.
If you are looking for edutainment this festival season, MAPS Director of Communication Randolph Hencken and MAPS Director of Field Development Brian Wallace will be giving presentations at three amazing festivals: Lightning in a Bottle, Raindance, and Alchemeyez.
This Memorial Day weekend they will speak at Lightning in a Bottle near Irvine in Southern California. Lightning in a Bottle (LIB) is one of the premier west coast art and music festivals. But LIB is more than just dancing and having fun, LIB seeks to inspire positive growth, change, and community. In this light, LIB offers a speaker series with Rev. Michael Beckwith, Daniel Pinchbeck, Chris Paine, Bashar, and Randolph and Brian; over 40 workshops about topics such as sustainability, composting, and permaculture; and several yoga classes. Information and tickets can be found at: http://lightninginabottle.org/
Raindance will take place in the Santa Cruz Mountains from June 4-6. This is a smaller festival that has real community atmosphere. Beyond bringing in dozens of world-class musicians, Raindance also hosts several workshops dedicated to progressive thinking. Raindance has limited capacity and will sell out. Tickets can be purchased at: http://www.raindancepresents.com/campout2010/index.php
Alchemeyez will be held on the big island in Hawaii from June 10-13, and will bring many of the most notable names in visionary art together to lead workshops. Artists attending include Robert Venosa, Martina Hoffmann, Alex and Allyson Grey, Luke Brown, Android Jones, and Autumn Skye Morrison. Alchemeyez has limited capacity and will sell out. Tickets can be purchased at: http://www.alchemeyez.com/Alchemeyez_Home.html
50 limited-edition, signed and numbered prints of Ann and Alexander "Sasha" Shulgin by Alex Grey
On Saturday, April 17, during the Shulgin tribute dinner at Psychedelic Science in the 21st Century, Alex Grey unveiled his newest portrait of Ann and Sasha Shulgin, "The Shulgins and Their Alchemical Angels." Fifty numbered limited edition prints of this portrait, signed by Alex, Sasha, and Ann are available through the MAPS webstore. Nearly half of these prints have already sold. Prices vary from $1500 to $3500, depending on the number (#1 sold at auction for $6600). Proceeds will be split between MAPS’ MDMA/PTSD research with veterans of war and Alex and Allyson Grey’s Chapel of Sacred Mirrors, with an honorarium to Ann and Sasha.