LSD and Psilocybin Research

June 28, 2010. 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.

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.

June 22, 2010. 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.

June 20, 2010. 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.

May 4, 2010. 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 subjects 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.

April 21, 2010. CNN. "Psychedelic Drugs For Your Health." With Campbell Brown and Sanjay Gupta, M.D.

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.

April 20, 2010. CNN. "Science Takes a New Look at Psychedelics." With Correspondent Dan Simon.

This television news article features short interviews with Rick Doblin and Michael Mithoefer, and coverage of the Psychedelic Science in 21st Century conference.

December 17, 2009. Eighth Subject Enrolled in LSD Trial

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.

December 3, 2009. 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.

October 26, 2009. Sixth Subject Enrolled in LSD Study.

The sixth subject out of an eventual 12 subjects has been enrolled in our LSD/end-of-life-anxiety study.

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 encourage MAPS supporters to host a viewing party in order to inform your friends and family about the benefits of psychedelic psychotherapy. In addition to this new documentary, MAPS has DVDs available of the Peter Jennings documentary, Ecstasy Rising, the best documentary ever made about MDMA. Depending on how you organize your party, you could show Ecstasy Rising at the same gathering after or before "Inside LSD." After watching one or both documentaries, wed like you to ask your friends and family to become MAPS members. This is perfect chance to take advantage of the 10-10-10 matching grant program mentioned above. If you are interested in hosting a party, please contact brian@maps.org with "National Geographic Party" in the subject line for more information about what materials MAPS can send you for distribution to the people at your party.

October 1, 2009. MAPS' LSD research was reported in Scientific American's article, "LSD Returns--For Psychotherapeutics," by Gary Stix. This article features commentary from MAPS-sponsored LSD researcher Peter Gasser, M.D.

September 27, 2009. An article about LSD reemerging in research laboratories by Erin Allday appeared on the front page of the San Francisco Chronicle's Sunday paper, "LSD's long strange trip back into the lab." .

August 31, 2009.

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.

April 8, 2009. 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.

November 25, 2008. 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.

November 3, 2008. MAPS Transfers $25,000 To The Swiss LSD Study:

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.

September 26, 2008. FDA Removes Clinical Hold on LSD Research--A Transformative Moment in Psychedelic History:

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.

The budget for our Swiss LSD/end-of-life anxiety study is $225,000. Weve raised about $125,000 and are still seeking the final $100,000.

July 6, 2008. The Sunday Baltimore Sun published an editorial ("Tuning In, Not Out") supporting research into the therapeutic potential of psychedelics. The editorial mentions the MAPS-supported research into MDMA-assisted psychotherapy in people with PTSD and ends by stating, "Instead of banning drugs that are perceived as bad simply because of their recreational use, scientists should be encouraged to pursue legitimate study - lest we miss out on a valuable medicinal tool."

July 3, 2008. Nature News published a piece on Griffiths' follow-up to his human psilocybin research. MAPS President Rick Doblin posted a comment in response to the piece.

July 2, 2008. 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.

July 1, 2008. 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.

Wired just published a story on Roland Griffiths' recently published 14-month follow-up to his initial human psilocybin study, and discusses another paper that he and collaborators M Johnson and W Richards publish in the same journal that presents guidelines for conducting research with high doses of psychedelic compounds, a report Griffiths describes in the Wired story as possibly the more important of the two papers.

CNN News produced a segment discussing Griffiths' follow-up research.

December 5, 2007. 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.

November 7, 2007. 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.

October 30, 2007. 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.

October 29, 2007. 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.

September 18, 2007. A major Swiss TV news report was broadcast earlier this month about Dr. Peter Gasser's MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to end-stage illness. The report includes a new interview with Albert Hofmann, who rarely speaks publicly due to his fragile health. Click here to watch the broadcast (in German, translation in process) on the MAPS site.

Dr. Gasser's protocol will be reviewed again on November 8 by the Swiss Ethics Committee (EC). The EC is reviewing a report about the protocol from a Swiss psychooncologist who raised issues about patient selection (cancer patients v. patients with a range of life-threatening illnesses) and the possibility of measuring any acute traumatic effects of the LSD experience. We expect that this meeting of the EC will resolve the final issues regarding protocol design.

The protocol has already been submitted to SwissMedic, the Swiss equivalent of the FDA. SwissMedic has begun its review and is waiting to consider the outcome of the EC meeting in November. After EC and Swissmedic approval have been obtained, we expect we'll need an additional several weeks to obtain final approval from the BAG, the Swiss equivalent of DEA. We expect the study to be fully approved by January11, 2008, Albert Hofmann's 102nd Birthday.

September 17, 2007. 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.

September 12, 2007. A major Swiss TV news report was broadcast earlier this month about Dr. Peter Gasser's MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to end-stage illness. The report includes a new interview with Albert Hofmann, who rarely speaks publicly due to his fragile health. Click here to watch the broadcast (in German) on the MAPS site. To follow the interview in English, we've posted an English-language transcript online.

Chemistry World's monthly podcast about medical research evaluating psychedelics features interviews with MAPS President Rick Doblin, PhD, and researcher John Halpern, MD.

July 13, 2007. 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.

March 21, 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.

February 19, 2007. Cosmos magazine published an article about medical research with LSD.

December 28, 2006. Nature featured an article describing MAPS-sponsored efforts to initiate research with LSD and psilocybin to treat cluster headaches, a rare and painful condition that is difficult to treat.

December 11, 2006. 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.

December 7, 2006. 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.

November 6, 2006. 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.

October 16, 2006. 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.

September 13, 2006. 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."

August 16, 2006. 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.

August 15, 2006. 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.

July 20, 2006. 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.

July 11, 2006. On Tuesday, July 11, a National Institute on Drug Abuse (NIDA) and Council on Spiritual Practices (CSP)-funded research team from John Hopkins University published in Psychopharmacology the first modern-day continuation of the Good Friday Experiment, finding that psilocybin is likely to induce spiritual experiences in most subjects. A former NIDA director and a former deputy director of ONDCP supported the results of the study in associated commentaries published with the article, but the current NIDA director issued a statement distancing NIDA from the study. Read about this amazing psychedelic research development as reported by the Economist, Washington Post, Wall Street Journal, LA Times, and ABC News, which features a salient quote from MAPS President Rick Doblin.

June 28, 2006. 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.

April 14, 2006. 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.

August 2, 2005. London's 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.