Dear MAPS Members and Supporters,
There is a lot happening in the psychedelic research world, but one matter is especially outstanding. On next Monday, July 19, the Journal of Psychopharmacology is publishing our paper on the MAPS-sponsored U.S. study of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD)! We have been contacting the press and will be sending you more information in a few days including the full article with the results that you have been waiting for.
Currently we have three MDMA studies that we are ready to begin, but we are in a frustrating holding pattern due to regulatory issues. We are confident that by strategically and methodically working within the system, we will eventually be able to start these studies, but we cant predict exactly when. Detailed information regarding these approval obstacles,as well as information about where we are making progress, can be found in the news items in this update.
Randolph Hencken, M.A.
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What’s happening this month at MAPS:
(Articles are below)
- MAPS Receives Substantial Donations from Dr. Bronner’s Magic Soaps, Joby Pritzker and the Scorpio Rising Foundation, Peter Lewis, and the Libra Foundation
- Albert Hofmanns Heirs Donate $3816 From Book Royalties to Swiss LSD Study
- MAPS Wins $5000 Guidestar/Great Nonprofits Contest
- Long-Term Follow-Up of U.S. MDMA/PTSD Pilot Study Nears Completion
- Recruiting Subjects for MDMA/PTSD Study in War Veterans; Awaiting DEA Review
- MDMA in Healthy Subjects / Therapist Training Study Awaits DEA Approval
- Swiss MDMA/PTSD One-Year Follow-Up Study Continues; Data Collection Underway
- Canadian MDMA/PTSD Study Still Seeking Permission to Import MDMA; Protocol Amendment Being Submitted
- Swiss LSD/End-of-Life Anxiety Study Moving Forward; Protocol Amendment Accepted by IRB
- New Database Prepared for LSD-Study in Accordance with FDA Best Practices
- International Federation of Psychotherapy Congress in Lucern, Switzerland hosts Mithoefers, Gasser, Oehen, and Passie
- Doblin, Mithoefers, and Richards present at 17th International Transpersonal Conference in Moscow
- Observational Study of Ayahuasca-Assisted Therapy for Addiction and Patterns of Dependence Receives Support From MAPS
- Ibogaine Protocol Submitted to IRB
- Beckley Foundation Seeks Participants for Online Survey of Drug Use; Johns Hopkins Seeks Participants for Online Survey of Psilocybin and Spiritual Experience
- New Podcasts from Psychedelic Science in the 21st Century Conference by Rak Razam with Grof, Sand, Shulgin, Garcia, Greys, Grob, Metzner, and Doblin
MAPS Receives Substantial Donations from Dr. Bronner’s Magic Soaps, Joby Pritzker and the Scorpio Rising Foundation, Peter Lewis, the Libra Foundation
On May 27, at the recommendation of David Bronner, Dr. Bronner’s Magic Soaps granted MAPS $100,000, of which MAPS passed on $5000 to the Wo/mens Alliance for Medical Marijuana (WAMM) and $8,150 to Erowid. On May 28, MAPS received $100,000 in unrestricted funds from Joby Pritzker and the Scorpio Rising Foundation.
On June 21, the Libra Foundation donated $25,000 to the study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans with war-related trauma. On July 9, philanthropist Peter Lewis donated $50,000, which we have allocated to our MDMA/PTSD study in veterans of war, which is projected to cost $500,000. Including these two new donations and a July 9, $2,500 restricted donation from Latane Temple Keeler, we have now raised over $100,000 for this study.
We wish to extend our sincere gratitude to all of those mentioned here for their substantial contributions to psychedelic and marijuana research.
Albert Hofmanns Heirs Donate $3816 From Book Royalties to Swiss LSD Study
On July 6, Andreas Hofmann, Albert Hofmanns son, informed us that his family has decided to donate $3816 in royalties from the sales of the 3rd edition of LSD: My Problem Child to our Swiss study of LSD-assisted psychotherapy for the treatment of anxiety associated with life-threatening illnesses. MAPS is the publisher of the book and has an agreement with the Hofmanns to split profits 50/50. We are grateful that the Hofmann family has opted to donate their royalties to the worlds only therapeutic study of LSD. Andreas wrote that his family was all in agreement about making the donation, because we all want to support this very important project. I’m glad that the research on LSD is making progress.
In response to receiving this donation, the studys Principal Investigator Peter Gasser, M.D. wrote, I joyfully thanked the family of Albert Hofmann. This donation doesnt mean money only, but also acknowledgement and respect for our work. Of course I am proud to do this work and to know that Albert Hofmann saw the beginning of the study. Now after his death to feel the attention and goodwill of his family is a warm support.
MAPS Wins $5000 Guidestar/Great Nonprofits Contest
On July 1,we won the Guidestar/Great Nonprofits Health Campaign 2010, thanks to the efforts of 603 MAPS supporters who submitted reviews of MAPS between June 1 and June 30, 2010. We will receive a prize of $5000 along with increased credibility and visibility. Over 115 organizations entered the contest and the two closest runner-ups had just 379 or 338 reviews. This is a remarkable testimony to the strength of our community. As we strive to achieve our vision of mainstreaming psychedelics as therapeutic medicines, we know that our supporters are ready to mobilize, eventually to triumph. Each small victory like this one builds our capacity to make further progress toward our mission and brings us closer to historic achievements in the future.Guidestar is sending an email out to 1 million people on Thursday, August 5, which will announce that we won the challenge.
Long-Term Follow-Up of U.S. MDMA/PTSD Pilot Study Nears Completion
Our long-term follow-up to our flagship study of MDMA-assisted psychotherapy for the treatment of PTSD, which has been taking place in Charleston, SC, is coming close to completion. All that remains is for the researchers, led by Principal Investigators Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., to collect follow-up information from a few more subjects. Weve already obtained long-term follow-up data from 16 of the 20 subjects, at an average of about 3 years after their final experimental session. The results so far are encouraging.
Recruiting Subjects for MDMA/PTSD Study in War Veterans; Awaiting DEA Review
We are now in the process of recruiting subjects for our study of MDMA-assisted psychotherapy for veterans with war-related PTSD. We are mostly seeking veterans from Iraq and Afghanistan but are looking for a few from Vietnam as well. The study, to be conducted by Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., will be our second MDMA/PTSD study to take place in Charleston, SC. The Mithoefers’ previous study of MDMA-assisted psychotherapy included subjects whose PTSD was primarily the result of sexual assault, abuse and violent crime, with just two veterans with war-related PTSD. This new study will only enroll veterans with war-related PTSD. We will also be able to enroll subjects with the previously excluded risk factors of Hepatitis C or controlled hypertension, with additional screening evaluations and safety measures for these subjects.
The final hurdle before the study is able to move forward is that Dr. Mithoefer must obtain a renewed Schedule I license to handle the MDMA required for the study. He has already been waiting over 3 months on the DEA’s Office of Drug and Chemical Evaluation (ODE) to complete its review of his license application, which he submitted after obtaining both FDA and IRB permission. Unlike the FDA, the DEA has no time limits for issuing licenses. The ODE informed us on July 13 that the review could take an additional four months or more, meaning we may have to wait until October to start the study unless we can find a way to motivate the DEA to move faster. President Obamas announcement on July 11 that it is a national priority to expedite treatment to veterans with PTSD may prove helpful.
MDMA in Healthy Subjects / Therap
ist Training Study Awaits DEA Approval
Although our protocol for studying MDMAs effects on healthy volunteers was approved by the FDA on October 3, 2009, and by the IRB on December 21, 2009, we are still waiting on the DEA’s Office of Drug and Chemical Evaluation (ODE) to provide Michael Mithoefer, M.D. with a Schedule 1 license for this study. In this study, Principal Investigator Dr. Mithoefer and co-therapist Ann Mithoefer, B.S.N., will be administering MDMA to healthy volunteers who are part of our therapist-training program. The study will also allow us to learn more about the effects of MDMA in healthy individuals, as opposed to patients with chronic, treatment-resistant posttraumatic stress disorder (PTSD). We expect that, as with the study in veterans of war with PTSD, the ODE will grant approval based on Dr. Mithoefers excellent track record. The ODE told Dr. Mithoefer that he could expect to have his license in the mail by June 9, though it has not yet arrived. On July 13, the ODE told MAPS Executive Director Rick Doblin, Ph.D. that the approval letter would be coming soon.
Swiss MDMA/PTSD One-Year Follow-Up Study Continues; Data Collection Underway
The experimental treatment portion of our Swiss study of MDMA-assisted psychotherapy for PTSD ended in January 2010. The long-term (one year) follow-up portion of the study is currently underway and will be concluded in January, 2011.
Our new volunteer research intern, Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology), is entering the completed data from the Swiss study into the clinical database at our office in Santa Cruz, CA. Audrey is now entering data from the ninth subject, out of 14 enrolled (12 completed and 2 drop-outs). In the interest of timeliness and accuracy, we will be checking the data as we go.
By the end of August 2010, we expect that this preliminary data entry will be completed. As the remaining subjects complete the long-term follow-up measures, we will be adding their data to the database. The final analysis will be completed shortly after the final subject participates in the long-term follow-up in January 2011. We are tentatively planning to complete the writing of a paper for publication in the spring of 2011.
Canadian MDMA/PTSD Study Still Seeking Permission to Import MDMA; Protocol Amendment Being Submitted
We seem to be making slow, gradual progress in getting our Canadian MDMA/PTSD study started. On June 14, 2010, Principal Investigator Ingrid Pacey, M.D., met in person with Health Canada officials in Ottawa. Wed previously been informed that Health Canada requires that we she officially affiliated with a Canadian research institution (and not just with MAPS). Prior to the June 14th meeting, Dr. Pacey had obtained affiliation with two different research institutes, the University of Victorias (UVic)Center for Addiction Research of BC(CARBC) and the University of British Columbias (UBC)Center for Health Evaluation and Outcome Studies(CHEOS),and had provided this information to Health Canada.
The new information that Dr. Pacey was told on June 14 was that we must obtain written proof of affiliation from the Dean of either of the two Universities with which these research institutions are affiliated. This seems to be a politically motivated requirement since the research institutes have already approved our affiliation. In the U.S. and Switzerland, weve been able to conduct our research without any outside institutional affiliation. In any case, Dr. Pacey and the research organizations will be seeking to obtain approval from the Deans of UBC and UVic. We are pursuing both options simultaneously since approval from either of the Deans is difficult to predict. Wed obtained approval for the actual protocol from both Health Canada and a Canadian IRB by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we have not been deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.
While we wait for institutional affiliation that will satisfy Health Canada, along with permission to import MDMA to start the study, MAPS is submitting an amendment to the original research protocol to Health Canada. We are adding additional long-term (one year) measurements of the effectiveness of MDMA-assisted psychotherapy for PTSD, as well as a new measurement that the FDA now requires for evaluating long-term suicidality in subjects taking any psychiatric drug, known as the Columbia-Suicide Severity Rating Scale (C-SSRS).
Swiss LSD/End-of-Life Anxiety Study Moving Forward; Protocol Amendment Accepted by IRB
On May 25, 2010, the Swiss Ethics Committee approved our amendment to the original LSD protocol that will allow us to make audio and video recordings of the therapy sessions. These recordings will be available to patients who request them and will enable our research team to study the tapes for the development of an LSD-assisted psychotherapy treatment manual.
On June 22, the 8th subject in our Swiss study of LSD-assisted psychotherapy for the treatment of anxiety associated with life-threatening illnesses had the first of two experimental sessions with LSD. Principal Investigator Peter Gasser, M.D. is now s
eeking to recruit the final of the 12 subjects required for the study. Meanwhile, we’re moving forward collecting follow-up data on the first of the subjects who have already completed the research program.
New Database Prepared for LSD-Study in Accordance with FDA Best Practices
Beginning on June 28, MAPS clinical volunteer research intern Tim Whalen has been building a database to house data from our Swiss study of LSD-assisted psychotherapy for the treatment of anxiety associated with life-threatening illnesses. The database will be used prior to the end of the study to provide data analysis in real-time, in accordance with the FDAs best practices guidelines. This is an important step for MAPS as we continuously improve our clinical operations and prepare for many more scientifically rigorous clinical studies. Tims volunteer work is saving MAPS several thousands of dollars.
International Federation of Psychotherapy Congress in Lucern, Switzerland hosts Mithoefers, Gasser, Oehen, and Passie
From June 16-19, the International Federation of Psychotherapy convened a Congress in Lucerne, Switzerland. As a sign of the growing acceptance of psychedelic psychotherapy research, this mainstream psychotherapy conference had a seminar devoted to the topic. From the U.S., MAPS sent researchers Michael Mithoefer M.D. and Annie Mithoefer, B.S.N. to present information from our U.S. MDMA/PTSD study. MAPS also brought Swiss MDMA/PTSD researchers Peter Oehen, M.D. and Verena Widmer, R.N. and Swiss LSD/end-of-life researcher Peter Gasser, M.D. Also on the panel was renowned German psychedelic researcher Torsten Passie, M.D. This was the first presentation about new data from psychedelic psychotherapy research to a mainstream psychotherapy conference in over 35 years.
Out of about 800 attendees at the conference, approximately 50 people crowded the room for the two-hour panel. According to MAPS Executive Director Rick Doblin, Ph.D. who also attended the conference, the session on psychedelic research was remarkable because it wasnt remarkable it was a mainstream psychotherapy conference that happened to have a panel on psychedelic psychotherapy research. There were no protestors or vocal dissenters. The promising results were taken seriously and our call for expanding research wasnt even considered controversial.
During the trip to Switzerland, MAPS supporter and friend Vanja Palmers hosted Rick and the Mithoefers at his home in Lucerne, only several blocks from the conference center.
Doblin, Mithoefers, and Richards present at 17th International Transpersonal Conference in Moscow
From June 23-27, the 17th International Transpersonal Conference took place in Moscow. Vladimir Maykov, Ph.D. and Stanislav Grof, M.D. organized the conference. MAPS was represented by Michael Mithoefer, M.D., Annie Mithoefer, B.S.N. and Executive Director Rick Doblin, Ph.D. MAPS also sponsored the attendance of distinguished psychotherapist and researcher William Richards, Ph.D., from the Johns Hopkins psilocybin research team funded by the Council on Spiritual Practices and the Heffter Research Institute. Also in attendance was Evgeny M. Krupitsky, M.D., Ph.D, who along with Rick chaired the panel on psychedelic research.
In the 1990s, Dr. Krupitsky was the only researcher in the world conducting legal psychedelic psychotherapy studies; he was investigating ketamine-assisted psychotherapy as a treatment for alcoholism and heroin addiction. Sadly, in 2002, the Russian government ended his research and to this day psychedelic research is completely forbidden in Russia. Despite this obstruction of scientific freedom, the Russian and international attendees were especially eager to hear the speakers discuss psychedelic research taking place in the U.S.
Observational Study of Ayahuasca-Assisted Therapy for Addiction and Patterns of Dependence Receives Support From MAPS
On June 8, MAPS granted $10,000 to an ayahuasca research project coordinated by Philippe Lucas, M.A. (of MAPS Canada) with Principal Investigator Gerald Thomas, Ph.D. The researchers are developing a protocol for an observational study of ayahuasca-assisted therapy for addiction and dependence. The study will take place in British Columbia, Canada, and will combine Western psycho-emotional therapeutic techniques with shamanic healing practices from the South American Vegetalismo tradition. The research intends to gather preliminary evidence of the potential of ayahuasca-assisted therapy to reduce problematic substance use as well as psychological and physical addictions, compulsive behavior, and self-harming thought patterns. It is anticipated that the protocol will be ready for submission to the University of Victoria Research Ethics Committee within the next few months.
Ibogaine Protocol Submitted to IRB
On June 2, MAPS Deputy Director Valerie Mojeiko submitted MAPS new protocol investigating the long-term outcomes of ibogaine treatment for people with opiate addiction for review to the Human Research Review Committee at the California Institute of Integral Studies (CIIS). The study is co-led by University of California, San Diegos Thomas Kingsley Brown, Ph.D., and CIIS graduate students Karim Rishi: Gargour, M.A. and Meg Ryan. The study is following patients at Pangea Biomedics in Playas de Tijuana, Mexico. The protocol is designed to follow 20 subjects, but if more funding is obtained we will add an additional 10 subjects to the protocol.
Beckley Foundation Seeks Participants for Online Survey of Drug Use; Johns Hopkins Seeks Participants for Online Survey of Psilocybin and Spiritual Experience
MAPS colleagues at the Beckley Foundation, in collaboration with the Department of Psychology at University College London (UCL), are conducting an online International Drug Survey. The survey is anonymous, and intends to find out what people think are the harms and benefits associated with recreational drugs from alcohol and caffeine to mescaline and amphetamines. Researchers at UCL and the Beckley Foundation already have more obtained information from more than 2500 respondents, and are hoping to get hundreds of thousands more. Visit www.internationaldrugsurvey.com to take the survey and help contribute to scientific research about how people really feel about recreational drugs.
Researchers at Johns Hopkins are studying the effects of psilocybin in healthy people.Now, they’re conducting an anonymous survey. If you’ve had a spiritual or meaningful psilocybin mushroom experience, visitwww.csp.org/hopkins/survey. Because many responses are needed, please share this survey with others.
New Podcasts from Psychedelic Science in the 21st Century Conference by Rak Razam with Grof, Sand, Shulgin, Garcia, Greys, Grob, Metzner, and Doblin
Freelance writer and wanderer extraordinaire Rak Razam has made available a number of MP3 podcasts of interviews with prominent participants at the Psychedelic Science in the 21st Century conference.
Podcast 1: Charles Grob, M.D., Ralph Metzner, Ph.D. and Rick Doblin, Ph.D.
Podcast 2: Sasha Shulgin, Ph.D., Carolyn Garcia, Alex and Allyson Grey
Podcast 3: Stan Grof, M.D. and Nick Sand
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