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.
December 22, 2005. Dr. Andrew Sewell's and Dr. John Halpern's research into the use of LSD and psilocybin in the treatment of cluster headaches has reached a major milestone, in that Dr. Sewell's colleagues recently submitted a case report series for publication with data from over 50 subjects.
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.
December 1, 2004. Currently Andrew Sewell and John Halpern are preparing a case series from responses to the clusterbusters surveys.
