http://www.maps.org/images/mapslogo-sm.gif http://www.maps.org/ 50 50 Psychedelic Research News http://www.maps.org/ Psychedelic Research News en-us editor@maps.org webmaster@maps.org Fri, 10 Feb 12 14:22:25 -0600 http://www.maps.org/media/view/last_two-month_follow-up_completed_in_swiss_study_of_lsd_psychotherapy_stud/ http://www.maps.org/media/view/last_two-month_follow-up_completed_in_swiss_study_of_lsd_psychotherapy_stud/#When:19:36:29Z 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 concludes the data collection portion of 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. http://www.maps.org/media/view/last_subject_treated_in_swiss_study_of_lsd-assisted_psychotherapy_for_end-o/ http://www.maps.org/media/view/last_subject_treated_in_swiss_study_of_lsd-assisted_psychotherapy_for_end-o/#When:21:52:56Z 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.” http://www.maps.org/media/view/swiss_lsd_study_team_submits_annual_report_to_fda_study_nears_completion/ http://www.maps.org/media/view/swiss_lsd_study_team_submits_annual_report_to_fda_study_nears_completion/#When:00:36:49Z 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. http://www.maps.org/media/view/swiss_lsd_study_in_final_stages/ http://www.maps.org/media/view/swiss_lsd_study_in_final_stages/#When:22:33:32Z 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. http://www.maps.org/media/view/twelfth_and_final_subject_enrolled_in_swiss_lsd_study/ http://www.maps.org/media/view/twelfth_and_final_subject_enrolled_in_swiss_lsd_study/#When:00:14:34Z 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. http://www.maps.org/media/view/twelfth_and_final_subject_to_be_screened_for_swiss_lsd_study/ http://www.maps.org/media/view/twelfth_and_final_subject_to_be_screened_for_swiss_lsd_study/#When:21:43:51Z 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. http://www.maps.org/media/view/maps_grants_10k_to_beckley_psilocybin_brain_imaging_study/ http://www.maps.org/media/view/maps_grants_10k_to_beckley_psilocybin_brain_imaging_study/#When:03:13:31Z 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. http://www.maps.org/media/view/swiss_irb_approves_subjects_with_life-shortening_illnesses_parkinsons_/ http://www.maps.org/media/view/swiss_irb_approves_subjects_with_life-shortening_illnesses_parkinsons_/#When:17:56:53Z 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. http://www.maps.org/media/view/new_database_prepared_for_lsd-study_in_accordance_with_fda_best_practices/ http://www.maps.org/media/view/new_database_prepared_for_lsd-study_in_accordance_with_fda_best_practices/#When:19:37:19Z 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. http://www.maps.org/media/view/swiss_lsd_end-of-life_anxiety_study_moving_forward_protocol_amendment/ http://www.maps.org/media/view/swiss_lsd_end-of-life_anxiety_study_moving_forward_protocol_amendment/#When:19:24:09Z 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.