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, 24 May 13 03:56:41 -0500 http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_anxiety_associated_with_advanced_illness_clo/ http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_anxiety_associated_with_advanced_illness_clo/#When:17:32:36Z 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. http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_anxiety_last_follow-up_interviews_complete/ http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_anxiety_last_follow-up_interviews_complete/#When:18:10:26Z 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. http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_end-of-life_anxiety_annual_report_submitted_/ http://www.maps.org/media/view/lsd-assisted_psychotherapy_for_end-of-life_anxiety_annual_report_submitted_/#When:22:19:06Z 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. http://www.maps.org/media/view/last_two-month_follow-up_completed_in_swiss_study_of_lsd_psychotherapy/ http://www.maps.org/media/view/last_two-month_follow-up_completed_in_swiss_study_of_lsd_psychotherapy/#When:19:36:22Z 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. 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.