MAPS News: October 2008 – MAPS’ LSD Joins MDMA and Psilocybin at the FDA
Dear MAPS Members, Supporters, and Friends,
It has been a busy transition into fall here at MAPS headquarters. We have received word from the FDA that the clinical hold on our LSD end-of-life psychotherapy study has been removed. Our ibogaine study is getting underway, and the development of our Canadian, French and Jordanian MDMA/PTSD studies are moving along at a considerable pace. Plus we have been able to help a handful of marijuana research projects and growing facilities at home and abroad.
By the time you receive this email, myself and the rest of the MAPS staff will be in San Francisco. There we are hosting a Saturday night soire to meet with MAPS members, and a Monday luncheon to honor Michael and Annie Mithoefers completion of our MDMA/PTSD pilot study.
We want to thank Tim Butcher, Jeff Crawford, and Kevin Herbert for each donating $5000 to MAPS for our US MDMA/PTSD project. At a time of economic turmoil, these donations are especially appreciated.
These are also very exciting times for our country. The next time you receive our monthly email update, we will know who the next president of the United States will be. The stakes are high. One of the candidates has publicly decried medical marijuana, while the other has stated that he would halt federal law enforcement raids on medical marijuana facilities in states that have medical marijuana laws. One of the candidates wives is a former drug addict, yet he supports the overly simplistic Nancy Reagan plan of Just say no. The other candidate has stated that he favors treatment over incarceration for first time drug offenders and opposes mandatory minimums. Perhaps most importantly to MAPS research, one of the candidates will allow religious ideology to stand in the way of science, while the other candidate has stated that his faith will not be used to prevent scientific exploration. You can probably guess which candidate is which.
Next month, we will tell you our post-election strategy for convincing the government to stop preventing Dr. Lyle Craker and our vaporized marijuana research. As the world economic markets spiral downwards it is going to be increasingly harder for us to acquire donations. We will need your support to implement our post-election strategy, and to continue all of the amazing research we are doing. Please make a donation today if you can.
Here’s a sample of whats going on:
- FDA Removes Clinical Hold on LSD Research–A Transformative Moment in Psychedelic History
- Get InvolvedHelp Us Find Opiate-Using Pain Patients Willing to Try Marijuana!
- David Magic Soap Bronner and MAPS Support Medical Marijuana in Israel and Canada
- At Long Last–Ibogaine Study Receives Approval
- Treatment Manual Seeks Key Elements of MDMA/PTSD Therapeutic Method
- Results of MAPS-Sponsored Spain MDMA/PTSD Study Published in Journal of Psychoactive Drugs
- Canadian IRB Requests Few Changes in MDMA/PTSD Protocol
- MDMA Therapy Inches Closer in France and Jordan with New MAPS-Sponsored Studies in Development
- MAPS Panel at Bioneers Conference in California on October 19
- Horizons Conference in NY Draws Large Audience, Generates Media Coverage
- MAPS President Rick Doblin, PhD Debates Drug Policy at Irelands Trinity College
- North American Ayahuasca Users Sought for Research Study
* * * 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 September 26th, 2008, the FDA issued a letter saying that we had successfully resolved all the outstanding issues in our Investigative New Drug application (#101,825) to evaluate LSD-assisted psychotherapy in our Swiss end-of-life/anxiety pilot study (PDF). FDA is now open to the possibility of the therapeutic potential of LSD-assisted psychotherapy and will accept data from our Swiss study.
FDAs acceptance of our pilot study for our Swiss LSD/end-of-life anxiety protocol is the culmination of the first phase of the psychedelic renaissance, MAPS President Rick Doblin PhD remarked emphatically.
It has taken several years for MAPS to reach this milestone with the FDA, This approval bolsters the belief that patience is the fastest way towards legitimizing psychedelic psychotherapy. In our culture, LSD is the most controversial of all the psychedelic drugs due to its association with the cultural rebellion of the 1960s, the implications of which are both celebrated and feared. The FDA has previously approved research with MDMA, psilocybin, DMT, ketamine, and mescaline. LSD is the last of the classic psychedelic drugs to be accepted as a research tool again, and the acceptance by the FDA of our Swiss LSD protocol is a transformative moment in the ongoing psychedelic renaissance.
Were requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. 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.
David Bronner, of Bronners Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachis facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years
David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to Davids $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us.
David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.
After a long struggle, weve finally obtained approval for our Mexican ibogaine outcome study.
On October 3, 2008, principal investigator John Harrison, PsyD candidate at the California Institute of Integral Studies (CIIS), received a letter from the Human Research Review Committee of CIIS granting final approval for the MAPS-sponsored ibogaine outcome protocol. John can now start our investigation into the short and longer-term outcomes of ibogaine treatment for opiate addiction.
The study will follow 30 patients who undergo ibogaine therapy at the Pangea Biomedics Ibogaine Association in Playas De Tijuana, Mexico for one year after their treatment.
In order to gather quantitative data about outcome, John will administer the Addiction Severity Index (ASI) on a monthly basis to each subject during an approximately one-hour phone conversation. Interviews with significant others will also be conducted, as a way to try to verify the accuracy of subject self-reports. Valerie Mojeiko, MAPS Director of Operations and Clinical Research, met with John Harrison to conduct a study initiation visit on October 9.
MAPS is thrilled to have this study underway after many years of incubation and delay. We recognize that drug abuse and drug addiction are realities in many peoples lives. As a result, it is important for us to support psychedelic research into approaches that try to lessen the harmful consequences of drug misuse.
The budget to conduct this study is estimated to be about $30,000, all of which remains to be raised.
From October 6-10, 2008, Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, worked on the MDMA/PTSD treatment manual. This was their second week working together in person, with a third week anticipated in December or January. They have reviewed many hours of videotapes of therapy sessions from Michael and Annies recently completed US MDMA/PTSD pilot study, with the aim of finding clear examples of the key elements of the therapeutic method. They intend to develop scales of approximately ten key elements of the therapeutic method. These scales would then be used by raters to evaluate researchers/therapists adherence to our specific therapeutic method.
The treatment manual, selected excerpts of the videotapes, and the scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan.
The fortieth edition Journal of Psychoactive Drugs published an article MDMA-Assisted Therapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder by Jos Carlos Bouso PhD candidate, Rick Doblin PhD, Mag Farr MD PhD, Miguel ngel Alczar PhD, and Gregorio Gmez-Jarabo PhD. This article reports on the MAPS-sponsored MDMA-assisted psychotherapy study in Spain that was prematurely shut down by the Spanish government. The abstract of the article is as follows:
The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented [in the article]. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.
The journals editors wrote as the first journal in the United States to address issues concerning drugs and drug abuse, the Journal of Psychedelic Drugs (the Journals previous name) was the product of its time and place (Haight Ashbury in the 1960s). The initial focus on psychedelic drugs very quickly moved on to other drugs appearing on that scene and over the years has grown into a wide-ranging interest in the seemingly endless variety of drugs that have become available to their consumers. The intent of the Journal has not changed: to provide honest and straightforward information about drugs to those who need to know more, whether they are researchers, those concerned about drug users, or concerned drug users.
Subscriptions to the journal can be found at this URL: www.hajpd.com. Normal rates are $25 plus shipping per issue and $90 for a yearly subscription. In honor of their special fortieth anniversary issue they have reduced rates to $70 (plus $30 shipping for non US orders) for a subscription and $20 for the special issue (shipping included, but non US orders add $5) for MAPS readers. Orders can be paid for via Paypal on their website: www.hajpd.com, where you can also read some articles from the earliest editions, starting in 1967. The text of the article will eventually be available online in databases such as pubmed.com.
The Institutional Review Board that is reviewing our Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted (PDF) . We were delighted to receive this letter since it is clear now that the study itself will be approved. The IRB has some issues of concern that need a further exchange of information before being resolved.
The issues of concern relate to the open-label stage 2 portion of the protocol, the age of enrollment, and prior substance-abuse history of subjects. In addition, the Canadian IRB stated that our informed consent form was too long and detailed for subjects to fully comprehend and needed to be significantly shortened. This is in stark contrast to our United States IRB, which wanted an exhaustive informed consent form. The US form was so long that we instituted a non-graded quiz at the end to make sure that the subjects understood the nature of the risks of MDMA-assisted psychotherapy and the key elements of the study design.
We are gathering letters of support for the Canadian protocol from various experts, and will respond soon to the IRBs concerns. Once the IRB approves a final version of the protocol and informed consent, we will then submit it to Health Canada Canadas version of the FDA. We hope to have this study fully approved and ready to begin in early 2009.
The budget for this study is $150,000, all of which remains to be raised.
On September 17, 2008, French psychiatrists Olivier Chambon and Fred Rosenfeld met with Patrick Lemoine MD in Lyon, France to discuss possibilities of starting a MAPS-sponsored MDMA/PTSD pilot study at a clinic where they work and that Dr. Lemoine directs. MAPS President Rick Doblin PhD and Director of Operations Valerie Mojeiko spoke in Paris in March 2008 at a conference about hallucinations in an attempt to catalyze MDMA/PTSD research [Link to article in current MAPS Bulletin on page 17]. On June, 28 2008, Valerie and Josh Sonstroem, MAPS Clinical Research Associates, conducted a site visit at the clinic where Drs. Chambon and Rosenfeld work.
After meeting with Drs. Chambon and Rosenfeld, Dr. Lemoine was intrigued but raised some concerns about MDMA neurotoxicity and cardiotoxicity. We sent detailed scientific information about those risks and await news as to whether we can move to the next stage of the project, which would be to develop a protocol that would be submitted to an Ethics Committee and the French Ministry of Health
On October 7, 2008, MAPS sent a draft of a protocol for a MAPS-sponsored MDMA/PSTD pilot study to Royal Jordanian Military psychiatrist Nasser Shuriquie. Dr Shuriquie needs to show the protocol to other medical officials to gauge whether there is sufficient support to justify submitting a final draft of the protocol to a Jordanian Ethics Committee and the Jordanian Ministry of Health. This version of our protocol differs from other pilot studies in several ways. It begins with a three-subject open label run-in in which both the subjects and the therapists know that MDMA is being administered. In this way, the therapist gets a chance to practice our therapeutic technique and become familiar with the therapeutic process before administering MDMA or placebo to other subjects in the context of a placebo-controlled, randomized, double-blind study. We believe that it is important for the therapist to get a chance to become comfortable with the procedure prior to starting a controlled study. The remainder of the protocol is a nine-person study, where six subjects receive three sessions of full-dose MDMA, 125 mg followed one-and-a-half to two-and-a-half hours later by 62.5 mg. Three subjects would receive active placebo, in this case 40 mg followed 1.5-2.5 hours later by 20 mg. Our Swiss, Israeli and Canadian MDMA/PTSD pilot studies are using 25 mg as the active placebo while our US study used an inactive placebo.
On October 19, MAPS President Rick Doblin, MAPS Director of Operations and Clinical Research Associate Valerie Mojeiko, and consciousness explorer Ralph Metzner will speak on a panel titled, Studying the Healing Potential of Psychedelics at the annual Bioneers Conference in San Rafael, California. The Bioneers conference hosts a range of presentations related to social and scientific innovations. Nearly 10,000 people are expected to attend to discuss and learn about practical environmental solutions and innovative social strategies for restoring Earths imperiled ecosystems and healing human communities. The conference takes place from October 17-19, and the MAPS panel is on Sunday at 2:45 PM. There are satellite locations where the conference will be aired by video.
MAPS will have a table at this event, as part of our educational outreach and membership development efforts. Our tables at festivals and conferences have been funded by a $5,000 donation from Seth Hollub. Bioneers has paid most of the expenses for this particular trip including entrance fees, lodging, and a complimentary exhibitor space.
Nearly 300 people packed Judson Memorial Church near Washington Square Park in NYC, for the second annual Horizons Conference, September 19-21, 2008. The audience heard talks by MAPS President Rick Doblin, pharmacologist David Nichols, Ann and Sasha Shulgin, psilocybin/mystical experiences researcher Dr. Roland Griffiths, visionary artists Alex and Allyson Grey, Author Daniel Pinchbeck, Video Artists Sean Helfritsch & Isaiah Saxon, conference promoter and psychotherapist Neal Goldsmith PhD, and others. Recordings of the talks are available online.
Steven Wishnia reported about Horizons on Alternet in this article called “What happens when you put 300 experts on psychedelics in the same room? [MAPS Permalink]
Horizons promoter Neil Goldsmith was interviewed on September 26, 2008 on Bob Fass’ radio show on WBAI FM in NYC. The topic was Psychotherapy, Psychedelics, and the Emergence of an Integral Society. You can listen to it at this URL: https://maps.org/avarchive/sept26.2008_radiounamable.mp3 [MAPS Permalink].
We extend our gratitude to Kevin, Hillary, and Martha for volunteering their time at our table at the conference.
MAPS President Rick Doblin was in Ireland from October 8-10, to debate drug policy reform at the world’s oldest debating society, in the 324th Session of the University Philosophical Society, Trinity College, Dublin, Ireland. The University Philosophical Society, which was founded in 1684, funded Rick’s trip to Ireland. Supporting the legalization of drugs was Rick, German publisher and drug legalization advocate Werner Pieper, columnist and blogger Tony Allwright (rebuttal text), and Trinity College’s Paul O’Mahony. Supporting continued criminalization was former Fine Gael (centre-right Irish political party) spokesperson on drug policy Damien English, and head of the Health Service Executive’s drugs and alcohol program Chris Murph.
“Traditionally, the Phil has been a paper-reading Society, which means that our debates generally open with an essay on the subject under discussion, prepared by one of our members.” Rick’s invitation stated. “Our invited speakers and members of the Society are then given the opportunity to speak in response and bring their expertise and experience to bear on the essayist’s ideas.”
The debate will be posted next week on the University Philosophical Society website: www.tcdphil.com
Psychologist Rachel Harris is conducting a research study about North Americans and their ayahuasca experiences. She is exploring whether their ayahuasca experiences change their lives in terms of behavior, decisions, beliefs, moods, and attitudes. This is the first study of its kind to explore these areas of ayahuascas lasting effects on North Americans. A recent study by another researcher found no evidence for a decline in the neurocognitive skills of US subjects who use ayahuasca in the Santo Daime religion.
Harriss early training was as a Residential Fellow at the Esalen Institute in the late 1960’s. She is the recipient of a National Institute of Health New Investigator Award. She has operated a private psychotherapy practice for over thirty years.
Persons who have used ayahuasca in North America are encouraged to download and take Harriss questionnaire (PDF) and then email it to her anonymously to ensure confidentiality.
We expect our workload to continue to ramp up as we head towards the latter portion of 2008. The Winter MAPS Bulletin is in the process of being created and will be mailed to members in the middle of November. If you aren’t a member, you are missing out on recieving our top notch publication. We would love to have you join the thousands of others who recieve our bulletin by becoming a member today.
Randolph Hencken, MA BS
Communications and Marketing Director, MAPS
You should also visit MAPS on youtube and myspace.
Hey you — don’t forget to tell all your friends to sign up for this newsletter!