MAPS has recently completed the first double-blind, placebo-controlled study of the therapeutic use of LSD in human beings since the early 1970s.
Experimental LSD capsule from our completed Swiss pilot study
LSD (lysergic acid diethylamide) is a semi-synthetic compound first developed in 1938 by Dr. Albert Hofmann at the Sandoz pharmaceutical company in Basel, Switzerland. After Dr. Hofmann first discovered its effects in 1943, LSD quickly became recognized for its possible therapeutic effects. LSD also played a significant role in the discovery of the serotonin neurotransmitter system.
Our recently completed Phase 2 pilot study in 12 subjects found positive trends in the reduction of anxiety following two LSD-assisted psychotherapy sessions. The study results also indicate that LSD-assisted psychotherapy can be safely administered in these subjects, and justify further research.
LSD is known for its ability to catalyze spiritual or mystical experiences and to facilitate feelings of interconnection. MAPS is interested in these substances for their potential to help people with a variety of conditions, focusing primarily on the treatment of anxiety associated with life-threatening illness, as well as for spiritual uses, creativity, and personal growth.
There is considerable previous human experience using LSD in the context of psychotherapy. From the 1950s through the early 1970s, psychiatrists, therapists, and researchers administered LSD to thousands of people as a treatment for alcoholism, as well as for anxiety and depression in people with advanced stage cancer. MAPS' completed and future research conforms to modern drug development standards, and will help guide the development of additional research into the risks and benefits of LSD-assisted psychotherapy.
Search our comprehensive Psychedelic Bibliography for scientific literature on the risks and benefits of LSD and other psychedelics.
LSD and Psilocybin for Anxiety Related to Life-Threatening Illness
LSD-Assisted Psychotherapy for Anxiety Associated with Life-Threatening Illness (Completed)
Location: Solothurn, Switzerland
MAPS is proud to sponsor the first study of the therapeutic use of LSD in humans in over 40 years. This study, based in Switzerland, investigates the safety and effectiveness of LSD-assisted psychotherapy in subjects with life-threatening illnesses and who are experiencing associated anxiety. The study received final approval from the BAG (the Swiss DEA) on December 5, 2007, final approval from the Ethics Committee (the Swiss IRB equivalent) on October 30, 2007, and clearance from SwissMedic (the Swiss FDA equivalent) on November 8, 2007. The first subject was enrolled on April 23, 2008, and all subjects have now been treated. The paper describing the results was published online on March 4, 2014, in the Journal of Nervous and Mental Disease.
Generous donations have been made by Robert Barnhart ($125,000), Kevin Herbert ($18,750), Vanja Palmers ($10,000), Fredi Muller (10,000 SF), Amanda Feilding/Beckley Foundation (5000 Euros), and Anonymous ($5,000). Thank you to all who contributed through book and art purchases as well!
Psilocybin-Assisted Psychotherapy for Anxiety Associated with Advanced Stage Cancer (Canceled)
MAPS has developed a protocol for a study of psilocybin-assisted psychotherapy in the treatment of anxiety associated with life-threatening illness.
This project has been canceled. We obtained Food and Drug Administration (FDA) approval for the protocol, the Principal Investigator's institution refused to permit him to submit the protocol to their Institutional Review Board (IRB). We are now developing a study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness.
On May 16, 2014, the annual report for LSD-assisted psychotherapy for anxiety associated with advanced-stage illness was submitted to the U.S. Food and Drug Administration. The required report provides an overview of the clinical and study methodology issues related to our Swiss LSD-assisted psychotherapy research from February 2013 through February 2014. Our completed study of LSD-assisted psychotherapy was published in the Journal of Nervous and Mental Disease on March 4, 2014, and reported in The New York Times and other international media. View the LSD annual report
Switzerland: Results Published in Journal of Nervous Mental Disease
On March 4, 2014, the results of our completed study of the therapeutic use of lysergic acid diethylamide (LSD) to treat anxiety associated with advanced-stage illness were published online in the peer-reviewed Journal of Nervous and Mental Disease. This is the first study of the therapeutic use of LSD in humans in over 40 years. The double-blind, placebo-controlled pilot study in 12 subjects found statistically significant reductions in trait anxiety following two LSD-assisted psychotherapy sessions. The results also indicate that LSD-assisted psychotherapy can be safely administered in these subjects, and justify further research. Eleven of the 12 subjects had never used LSD previously. “The study was a success in the sense that we did not have any noteworthy adverse effects,” reports Principal Investigator Peter Gasser, M.D.. “All participants reported a personal benefit from the treatment, and the effects were stable over time.” Download the paper…
On March 4, 2014, the results of the first study of the therapeutic use of lysergic acid diethylamide (LSD) in humans in over 40 years were published online in the peer-reviewed Journal of Nervous and Mental Disease. Sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the double-blind, placebo-controlled pilot study in 12 subjects with advanced-stage illness found statistically significant reductions in anxiety following two LSD-assisted psychotherapy sessions.
Switzerland: Paper Accepted for Publication in Journal of Nervous and Mental Disease
On December 23, 2013, the results of our completed Swiss study of LSD-assisted psychotherapy for anxiety associated with life-threatening illness were accepted for publication in the peer-reviewed Journal of Nervous and Mental Disease. This will be the first paper published about a new study of LSD-assisted psychotherapy in over 40 years! This double-blind, placebo-controlled pilot study in 12 subjects found positive trends in the reduction of anxiety following two LSD-assisted psychotherapy sessions. The study results also indicate that LSD-assisted psychotherapy can be safely administered in these subjects, and justify further research. To learn more about the history and significance of this study, download Principal Investigator Dr. Peter Gasser’s update from the Spring 2013 MAPS Bulletin.
Paper Resubmitted to Scientific Journal with Responses to Reviewer Comments
On November 14, 2013, the results of our completed study of LSD-assisted psychotherapy for anxiety associated with life-threatening illness were resubmitted for publication in a peer-reviewed scientific journal. The paper, which reports on the first study of the therapeutic use of LSD in over 40 years, was originally submitted to the Journal of Nervous and Mental Disease on August 9. On October 8, reviewers responded with comments requesting additional references along with a discussion of secondary outcome measures collected in the study related to quality of life and additional psychological symptoms. We’re cautiously optimistic that the paper will be accepted for publication without requiring further changes.
Paper Resubmitted for Publication after Editorial Rejection
On August 9, 2013, the results of our completed study of LSD-assisted psychotherapy for anxiety associated with life-threatening illness were resubmitted for publication in a second peer-reviewed journal, the Journal of Nervous and Mental Disease. We initially submitted the paper to the American Journal of Psychiatry, one of the world’s top psychiatry journals, on June 30, but the editors rejected the paper without sending it to reviewers. The Journal of Nervous and Mental Disease is another prominent journal which published many of the pioneering LSD studies from 1956–1973. Led by Principal Investigator Peter Gasser, M.D., this was the first completed study of LSD in humans in over 40 years.The first subject was enrolled on April 23, 2008, and the last long-term follow-up interview was conducted on August 8, 2012.
Results Submitted for Publication in Peer-Reviewed Journal
On June 20, 2013, the paper reporting the results of our completed study of LSD-assisted psychotherapy for anxiety associated with life-threatening illness was submitted for review by a peer-reviewed scientific journal. Led by Principal Investigator Peter Gasser, M.D., this was the first completed study of LSD in humans in over 40 years.
LSD-Assisted Psychotherapy for Anxiety Associated with Advanced Illness: Closeout Visit Conducted
From September 3-7, 2012, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., visited the study site for our completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness for the final closeout meeting with Principal Investigator Peter Gasser, M.D. During the visit, the researchers collected study case report forms, ensured that data accountability procedures were in place, and the data files were complete and ready to be stored. The team also made progress preparing the results for publication.
LSD-Assisted Psychotherapy for Anxiety: Last Follow-Up Interviews Complete
On August 8, 2012, the last long-term follow-up interview was conducted in our recently completed study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness in Switzerland. All twelve subjects have now completed the follow-up portion of this study, and the results are being prepared for publication. MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., is scheduled to visit Switzerland in September for the final monitoring visit.
LSD-Assisted Psychotherapy for End-of-Life Anxiety: Annual Report Submitted to FDA
On May 2, 2012, the MAPS clinical team submitted to the FDA the annual report (PDF) for our ongoing long-term follow-up to our Swiss study of LSD-assisted psychotherapy for anxiety associated with life-threatening illness. The report summarizes the current status of the study, including information about enrollment and subject demographics, amendments to the study protocol, and the occurrence of any adverse events associated with participation in the study. Lead investigator Peter Gasser, M.D., several Swiss co-authors, and the MAPS clinical team are currently preparing a paper about the results to be submitted for publication in a peer-reviewed scientific journal.
Last Two-Month Follow-Up Completed in Swiss Study of LSD Psychotherapy Study
By October 21, 2011, five out of 12 subjects have completed the long-term follow-up portion of our Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness. These long-term follow-ups take place at least 10 months following subjects’ final treatment sessions. The last two-month follow-up visit was completed on July 26, 2011. This was the first clinical LSD study in over 35 years. The results from the treatment period of the study are now being prepared for publication in a peer-reviewed scientific journal. The clinical team is now collecting long-term follow-up data in the form of additional interviews and psychiatric measures from subjects who have completed treatment, 10 or more months after their final treatment session. Five out of 12 subjects have now completed the long-term follow-up portion of the study. Once this data has been collected, the clinical team will prepare the final report for submission to SwissMedic and the U.S. FDA, and will submit the results for publication in a peer-reviewed scientific journal.
On May 26, 2011, the 12th and final subject was treated in MAPS’ Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced-stage illness. Once we collect follow-up data from this subject in July, we will have completed the first clinical LSD study in a patient population in over 35 years, representing a major milestone in the renaissance of psychedelic research. In 30 treatment sessions, not a single subject experienced severe negative reactions (serious adverse events, or SAEs) such as psychotic experiences, suicidal crises, flashbacks, or severe anxieties (bad trips). According to Clinical Investigator Peter Gasser, M.D., all 12 patients reported benefits from the treatment—however, it is too early to say whether the results will be statistically significant. Regardless of statistical significance, however, the preliminary results indicate that the risk of administering LSD in carefully controlled clinical settings is acceptably low, and that there is a promising future for LSD research. You can also read more about the historical significance of this study in David Jay Brown’s May 27 article, “Landmark Clinical LSD Study Nears Completion.”
Swiss LSD Study Team Submits Annual Report to FDA; Study Nears Completion
On May 3, 2011, our clinical research team submitted to the FDA the annual report for our nearly-completed Swiss study of LSD-assisted psychotherapy for anxiety associated with advanced life-threatening illness. Annual reports are designed to give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) applications. In our report, which covered all study activity between February 28, 2010, and February 28, 2011, we provided information about enrollment (including the total number of subjects enrolled for each study), demographics (such as height, weight, race, and illness), amendments to the study protocol, and the occurrence of serious and severe adverse events. Although there have been three serious adverse events over the course of the study, they were related to disease progression or accidents and not to administration of LSD.
On May 26, 2011, the 12th and last subject will undergo his last experimental therapy session. The MAPS clinical team is conducting a preliminary data analysis and finalizing the clinical database for the FDA. Statisticians at the University of Zurich working with Franz Vollenweider, M.D., will be conducting the analysis to assist Clinical Investigator Peter Gasser, M.D., in preparing a manuscript for publication.
From February 17-19, 2011, in yet another stop on her whirlwind international tour, MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., met with Clinical Investigator Peter Gasser, M.D., in Switzerland to monitor the progress of our Swiss study of LSD-assisted psychotherapy for end-of-life anxiety. The study has completed recruitment, with 11 of 12 subjects having received LSD-assisted psychotherapy with either a full dose or a low dose of LSD. Preliminary data has been collected for an interim analysis. During her visit, Yazar-Klosinski also trained Christina Blank, a new study coordinator who will be conducting follow-up interviews with subjects in the Swiss LSD study. Blank previously worked with as a research associate with psychedelic researcher Franz Vollenweider, M.D. Subjects will be interviewed for at least 10 months after their final treatment session in order to gather qualitative and quantitative data about their anxiety symptoms and health. Results from the follow-up extension study will be compared with the quantitative data gathered during the treatment phase of the study.
Twelfth and Final Subject Enrolled in Swiss LSD Study
On January 11, 2011, our clinical team announced that the
twelfth and final subject passed the screening process and was enrolled in our Swiss
study of LSD-assisted psychotherapy for anxiety associated with
life-threatening illness. The study, which is taking place in Solothurn,
Switzerland, is led by Principal Investigator Peter Gasser, M.D., and is the
first clinical study of LSD in humans in over 35 years. We anticipate that the
treatment phase of the study and the two-month follow-up evaluations will be
completed before Fall 2011, at which point the results will be analyzed and
submitted to a peer-reviewed scientific journal. A subsequent paper will report
on the data from the 12-month follow-up evaluations.
Twelfth and Final Subject to be Screened for Swiss LSD Study
The twelfth and final subject in MAPS’ study of LSD-assisted psychotherapy to treat anxiety associated with life-threatening illnesses is now in the screening process. The study is taking place in Solothurn, Switzerland, and is led by Clinical Investigator Peter Gasser, M.D. Our goal is to enroll the twelfth subject and have the study completed by the late spring of 2011. When the study is completed and the data is analyzed, a paper about the results will be written and submitted for publication in a peer-reviewed scientific journal.
We are simultaneously sponsoring a long-term follow-up study of our subjects. This portion of the study will collect data from subjects one year after their treatment session to see whether results are sustained over time. One subject has completed the long-term follow-up so far. When this research is complete, we will prepare a separate paper for a peer-reviewed journal.
MAPS Grants $10K to Beckley Psilocybin/Brain Imaging Study
On Sept. 29, we wired $10,000 USD in grant money to help fund a British study that aims to discover how psilocybin works in the brain. The study investigators, Robin Carhart-Harris, Ph.D., Richard Wise, Amanda Feilding and David Nutt, Ph.D., will use brain imaging to measure the effects of psilocybin on brain activity and connectivity at rest, during attentional processing and during autobiographical recollection. The researchers will measure increases and decreases in activity induced by the drug in different regions of the brain. The study is part of the Beckley Foundation/Imperial College Psychedelic Research Programme, and is supported in part by $10,000 grants from both MAPS and the Heffter Research Institute.
Researchers, already armed with an understanding of functional and effective connectivity, hope the study will reveal network relationships between different brain regions and show whether activity in certain regions is exerting a causal or driving influence over activity in others. The researchers hope to address the hypothesis that psilocybin lowers repression and facilitates autobiographical recollection. If this hypothesis is supported, it will: 1) indicate that psilocybin can facilitate the recollection of memories, 2) offer a biological explanation for how this occurs, and 3) indicate how psilocybin might be useful as an adjunct to dynamic psychotherapy.
Swiss IRB Approves Subjects with Life-Shortening Illnesses: Parkinson’s and Bechterew’s Disease
The Swiss IRB approved two new subjects for our LSD study (subjects #10 and #11) who have anxiety related to their disease which will likely reduce their lifespan, although their condition is not likely to be fatal in the next few years. The subjects suffer from Parkinson’s Disease and Bechterew’s Disease. Since this is an exploratory study, we’ve decided it is worthy of scientific investigation to accept a few subjects with major anxiety over a life-shortening disease, rather than a life-threatening disease. This will enable us to gather preliminary information about a broader range of potential subjects for future LSD-assisted psychotherapy research.
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.
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 seeking 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.
This is one of many great media pieces that arose from the Psychedelic Science in the 21st Century conference. This television news piece features interviews with Steven Ross, M.D. from the NYU psilocybin/cancer research team and CNN health correspondent Sanjay Gupta, M.D.
Monitoring Visit Conducted on Swiss MDMA and LSD Studies
In late February, MAPS Clinical Operations Manager Amy Emerson, Deputy Director Valerie Mojeiko, and MAPS new clinical research specialist Berra Yazar Ph.D., conducted a monitoring visit in Switzerland. They worked with Peter Oehen M.D. on the Swiss MDMA/PTSD study, which has completed treating all 12 patients, to help prepare the data for reporting to Swiss Medic and the FDA, and also for writing an article for submission to a scientific journal.
This same team also paid a monitoring visit to Peter Gasser M.D.s MAPS-sponsored Swiss LSD/end-of-life study. The monitoring visit revealed that its more difficult than we had originally anticipated to work with people who are close to dying, because their underlying disease process affects their health and their anxiety, as well as their ability to come to the psychotherapy sessions on a schedule.
Swiss LSD researcher Peter Gasser had a teleconference with Rick Doblin, Ph.D., MAPS Research and Information Specialist Ilsa Jerome, Ph.D., and MAPS Clinical Research Associate Berra Yazar, Ph.D. They discussed ways to align the windows during which certain procedures should be taking place with the diminished abilities to keep to a schedule of the actual patient population that they are working with.
The eighth subject has been enrolled in the MAPS-sponsored clinical trial evaluating LSD to alleviate anxiety associated with a life-threatening illness. The subject has completed the screening process and will be given an experimental LSD session in the coming weeks. Principal investigator Peter Gasser, M.D, is leading the study.
Swiss LSD Study is Renewed for Another Year by SwissMedic
SwissMedic, Switzerlands equivalent of the FDA, permitted our LSD/end-of-life study to proceed for another year. We are pleased with the outcomes of the study so far. Recruitment has been challenging, but we are now treating our sixth subject out of an eventual 12 and a seventh subject is being screened for inclusion.
The sixth subject out of an eventual 12 subjects has been enrolled in our LSD/end-of-life-anxiety study.
View As Single Entry > October 12, 2009 "Inside LSD" Broadcast on National Geographic Explorer 11/3/09 -- Host a Viewing Party to Build Community and Increase MAPS Membership With Our Matching Grant Program!
On Tuesday, November 3 at 10:00 PM EDT/7:00 PM PDT, National Geographics "Explorer" program will be featuring a documentary about the renewal of psychedelic research, focusing on LSD and psilocybin. The episode "Inside LSD" interviews several of MAPS colleagues and friends including pioneering psilocybin researcher Charles Grob, M.D. and one of the cancer patients in his psilocybin /cancer anxiety study
Here is how the show is described by National Geographic:
"Now science is taking a fresh look at LSD, including the first human trials in over 35 years. Using enhanced brain imaging, non-hallucinogenic versions of the drug and information from an underground network of test subjects who suffer from an agonizing condition for which there is no cure, researchers are finding that this trippy drug could become the pharmaceutical of the future. Can it enhance our brain power, expand our creativity and cure disease? To find out, Explorer puts LSD under the microscope." [read more].
We submitted to the FDA the annual report about our LSD research. Annual reports are designed to give the FDA an overview of new developments. We reported on the progress from the first 4 subjects out of an eventual 12 in our Swiss LSD/end-of-life study. We were able to report that there were no drug-related Serious Adverse Events (SAEs) and that our research was conducted safely. Its too early to say anything about efficacy.
Swiss LSD/End-of-Life Study Receives $25,695 donation:
On April 8, Robert Barnhart generously donated $25,695 to MAPS for our Swiss LSD/End-of-Life study. Robert has now donated over $100,000 to this study, with another $25,000 pledged for next month. This study is fully funded; now we can focus just on treating patients.
MAPS Clinical research team members Valerie Mojeiko and Joshua Sonstroem are currently out “in the field” meeting with MAPS researchers around the world on a several week- monitoring trip. Valerie currently writes from Switzerland where they have just finished a visit with our MDMA/PTSD therapy site under the direction of psychiatrist Peter Oehen, MD and are currently working with psychiatrist Peter Gasser, MD at our LSD/end-of-life anxiety study.
“I am amazed at how many regulations there are and how difficult it is to conduct this type of research accordingly,” said Valerie, “Only with careful attention to detail are we able to succeed in keeping up with the regulations—the researchers in Switzerland have put much effort into this endeavor.” These visits to the research sites not only keep our research compliant with International Council on Harmonization/Good Clinical Practice (international ethical and scientific quality standard for pharmaceutical research) (ICH/GCP) guidelines, but also serve as a way to communicate between research teams and identify training or resource needs and other opportunities. “It is great to see the data firsthand and to hear stories from the researchers of the people who were helped by this therapy—Im glad to be a part of this research,” said Valerie.
Swiss LSD/End-of-Life Anxiety Study Annual Report Completed: Dr. Peter Gasser, the Principal Investigator (PI) for the MAPS-sponsored LSD/end-of-life anxiety study, issued the first Annual Report discussing the progress weve made in this last year. Were making gradual progress in what will become the first study of the therapeutic use of LSD in almost 40 years.
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.
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.
A web exclusive piece published online by Newsweek discusses Griffiths' psilocybin research and his piece containing guidelines for human research with psychedelic compounds, relating it to the history and future of human stuides with psychedelic compounds.
Roland Griffiths and his study of psilocybin have made the news again, as recounted in this Associated Press news report, with the appearance of a 14-month follow-up to his original study that reported mystical experiences after psilocybin, but not methylphenidate. In the follow-up, people continue to say their experiences with psilocybin were some of the most meaningful in their lives.
Dr. Peter Gasser’s MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with anxiety secondary to advanced-stage illness received final approval from the BAG (Swiss DEA) on December 5, Ethics Committee (Swiss IRB equivalent) approval on October 30 and SwissMedic (Swiss FDA equivalent) clearance on November 8. This study—the first to evaluate LSD’s therapeutic applications in over 35 years—will be initiated in early 2008.
In September, MAPS submitted an application to FDA for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma. On October 18, we learned that the study will receive clearance from FDA, with only one clinical hold due to a request from FDA for a stability study of the psilocybin. The study was conducted earlier this month, and the results showed that the psilocybin is 100% pure. The results will be submitted to FDA soon. Earlier this month, we also submitted the protocol to an IRB, where it is currently under review.
MAPS President Rick Doblin, PhD, spoke at the second annual Clusterbusters conference in Austin, Texas, held from October 26-28. At a Clusterbusters business meeting after the conference, MAPS donated $26,000 to Clusterbusters for the protocol development and approval process for LSD/psilocybin cluster headache research. Clusterbusters and McLean Hospital, Harvard Medical School, have entered into an agreement calling for Clusterbusters to cover expenses related to protocol development and FDA, IRB and DEA approval for studies at McLean into the use of LSD and psilocybin in the treatment of cluster headaches. MAPS' donation will further Clusterbusters' funding of its contract with McLean Hospital. Dr. John Halpern is leading the LSD/psilocybin cluster headache research effort at McLean Hospital.
MAPS raised these funds in 2005 from the sale of Dean Chamberlain's signed and numbered prints (1 -50) of his portrait of Albert Hofmann, at which time our only active project intending to study LSD and psilocybin was the cluster headache research. MAPS currently has for sale a larger and more limited edition (1-25) set of prints of Dean's portrait of Albert, also signed by Albert, with funds from those sales going to support MAPS-sponsored LSD and psilocybin psychotherapy research in people with anxiety associated with end-of-life issues.
London's Guardian published an article about a consulting survey of the British public finding that Albert Hofmann, PhD, shares the top spot for #1 as the person considered to be the greatest living genius. Hofmann, the Swiss chemist who is best known for synthesizing LSD, shares the top spot with British computer scientist Tim Berners-Lee, and surprisingly ranks ahead of Stephen Hawking (#7), Nelson Mandela (#5), Matt Groening (#4) and George Soros (#3). Click here to read "Sheer Genius: From the Web to Homer Simpson." In 2006, MAPS published a new edition of Hofmann's long-out-of-print autobiographical book, LSD: My Problem Child. MAPS is also raising funds for LSD and psilocybin research by selling books and visionary artwork signed by Albert Hofmann. For details and more information, please visit the MAPS Webstore.
Later this week, MAPS will submit an application to FDA this week for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma. The study will take place in the US and will evaluate nine subjects with anxiety secondary to advanced-stage melanoma. MAPS has been working with the researchers on protocol development for over one year. The protocol was submitted last month to FDA and to an IRB, with the review currently in process. We will be able to post the protocol on the MAPS Website and disclose the names and institutional affiliations of the researchers after the study receives IRB and FDA approval. The researchers for this study have generously offered to volunteer their time, which will reduce overall costs significantly. The estimated budget for this study is $50,000, all of which remains to be raised.
Chemistry World's monthly podcast (MAPS Permalink to the MP3 File) about medical research evaluating psychedelics features interviews with MAPS President Rick Doblin, PhD, and researcher John Halpern, MD. A transcript of the interview is also is available.
Yesterday, Peter Gasser, MD, received final approval from the Ethics Committee (Swiss IRB equivalent) for a MAPS-sponsored study to evaluate the safety and efficacy of LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to life-threatening illness. Dr. Gasser originally submitted his protocol on January 10, 2007, received conditional approval in March, and has been working closely with the Ethics Committee in the meantime to refine the protocol design to address the committee’s concerns. Today, July 13, Dr. Gasser submitted the protocol to SwissMedic, the Swiss equivalent of FDA. Thankfully, like FDA, SwissMedic must respond to the application within 30 days.
Obtaining Ethics Committee approval is the first of three formal regulatory reviews for the protocol to obtain full government approval. After SwissMedic approves the study, Dr. Gasser will submit an application to the BAG (Swiss DEA) for a license to possess and administer the LSD to be used in the study. We were previously informed by a staff member at the BAG that its review process should take about a week, so we are still planning to begin the study by the Fall of 2007.
Dr. Peter Gasser submitted his protocol to the Swiss Ethics Committee on January 10, 2007, for a study to evaluate the safety and efficacy of LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to life-threatening illness. On March 19, we learned that Dr. Gasser had a promising discussion with the Chair of the Ethics Committee (Swiss IRB equivalent) about the design of his proposed MAPS-sponsored pilot study. Dr. Gasser was informed that the Ethics Committee had several concerns about the protocol design that would be expressed to him in writing before the end of April. He was also informed that these concerns were about how the study should be conducted, not about whether the study should be conducted. We’ll soon have a clearer idea as to how the Ethics Committee thinks the protocol should be modified.
Today’s BBC News features an article describing Dr. Francisco Moreno’s Heffter- and MAPS-sponsored research at the Univ. of Arizona-Tucson evaluating psilocybin-assisted psychotherapy as treatment for individuals suffering from treatment-resistant Obsessive-Compulsive Disorder (OCD). Dr. Moreno recently published his findings in the Journal of Clinical Psychiatry.
The Chronicle of Higher Education published the article “Researchers Explore New Visions for Hallucinogens.” This article describes the current renaissance in psychedelic research, particularly Dr. Francisco Moreno’s recently-published Heffter- and MAPS-sponsored study evaluating psilocybin as treatment for OCD. The article also discusses the recent psilocybin/mystical experience study at John Hopkins, and Dr. Charles Grob’s ongoing Heffter’ sponsored study at UCLA evaluating psilocybin-assisted psychotherapy as treatment for individuals with anxiety disorders secondary to advanced-stage cancer.
The Spanish-language journal Revista de Neurologia published a case report of a man with chronic cluster headaches treating the condition with monthly sub-psychedelic doses of psilocybin-containing mushrooms.
The Globe and Mail published an editorial entitiled, “The LSD Treatment”, describing a study just published in the journal Social History of Medicine about a long-term follow-up study on Dr. Humphrey Osmond’s research treating alcoholics with LSD-assisted therapy.
The science journal Nature reported today on MAPS-initiated research at Harvard/Maclean Hospital investigating the efficacy of LSD and psilocybin to treat cluster headache. Click here to read “Dropping acid may help headaches.”
Health Reporter Jim Ritter published in the Chicago Sun-Times today “Pain Sufferer Turns to ‘Shrooms’.” The article describes the use of psilocybin as a treatment for cluster headaches and MAPS-initiated research at Harvard/McLean Hospital investigating LSD and psilocybin as treatment for subjects with cluster headache.
In their “Newsdesk” section, the journal Lancet Neurology published “Hallucinogen Research Inspires Neurotheology,” a report on developments in research with psychedelic compounds, such as ketamine or psilocybin. The piece contains comments from Roland Griffiths, John Halpern and Deborah Mash.
We’re posting today a report about a very unusual death linked to LSD written on Oct. 2, 1982, by MAPS President Rick Doblin. We’re making this public as part of MAPS’ educational mission and as part of our mission to lead the way into research into the risks of psychedelics as well as the benefits. Coincidentally, on January 13, 2006, after a lecture Rick Doblin gave at the LSD conference in Basel held to honor Albert Hofmann on his 100th birthday, Rick was asked a question about a death linked to LSD. After some discussion, it turned out the question was about the same person as discussed in the report we are posting today.
Results of Dr. Andrew Sewell and Dr. John Halpern’s interviews with people who reported attempting to treat their cluster headaches with psilocybin-containing mushrooms or LSD are now published in the journal Neurology. Their results are promising and lend support to embarking on further research into the therapeutic potential of these drugs.
A recently published editorial in the Lancet supports research into the potential therapeutic benefits of psychedelic drugs and calls for a new legal structure that makes this research easier and less burdensome to conduct. The Lancet editorial was likely inspired by a commentary published in the British Journal of Psychiatry. This editorial was then covered by the British newspaper, the Guardian.
Guardian publishes a positive article by Mark Honigsbaum, "Headache sufferers flout new drug law- Calls for clinical trials and rethink of legislation as patients claim that magic mushrooms can relieve excruciating condition." MAPS' effort to sponsor research into the use of LSD and psilocybin in treating cluster headaches is favorably mentioned.
London Publication Mail on Sunday reports on Francis Crick, the Nobel Prize-winning father of modern genetics, who was under the influence of LSD when he first deduced the double-helix structure of DNA nearly 50 years ago.