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 Tue, 21 May 13 00:09:13 -0500 http://www.maps.org/media/view/u.s._veterans_study_13th_subject_completes_experimental_mdma-assisted_/ http://www.maps.org/media/view/u.s._veterans_study_13th_subject_completes_experimental_mdma-assisted_/#When:18:52:47Z On May 3, 2013, the 13th subject completed their second experimental MDMA-assisted psychotherapy session in our ongoing study for veterans, firefighters, and police officers with service-related PTSD. This subject is the second firefighter with chronic, treatment-resistant PTSD to be enrolled in this study, which will enroll 24 total subjects. Four subjects have now completed the study, including the long-term follow-up portion. http://www.maps.org/media/view/u.s._boulder_study_dea_mdma_order_forms_arrive_at_study_site/ http://www.maps.org/media/view/u.s._boulder_study_dea_mdma_order_forms_arrive_at_study_site/#When:18:52:21Z On April 30, 2013, the DEA Schedule I Controlled Substance order forms arrived at the site for our upcoming study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. Receiving these forms from the DEA, which took two months, marks the end of the regulatory approval process since we have now ordered the MDMA and can soon initiate the study. http://www.maps.org/media/view/social_anxiety_in_autistic_adults_fda_approves_protocol_design_for_new/ http://www.maps.org/media/view/social_anxiety_in_autistic_adults_fda_approves_protocol_design_for_new/#When:18:45:45Z On April 30, 2013, the U.S. Food and Drug Administration approved the protocol design for our pioneering study of MDMA-assisted therapy for social anxiety in autistic adults. The Advice Letter (pdf) from the FDA requested several changes to the exclusion criteria involving subject safety, some of which we thought were not necessary based on existing scientific literature. We have prepared an amended protocol incorporating some of these changes, along with evidence for why we don’t think the other changes are necessary. Once the FDA has reviewed and approved this amendment, we will submit the protocol and study materials for review by the Institutional Review Board at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study. http://www.maps.org/media/view/israel_first_subject_completes_experimental_mdma-assisted_psychotherapy_ses/ http://www.maps.org/media/view/israel_first_subject_completes_experimental_mdma-assisted_psychotherapy_ses/#When:18:51:00Z On April 17, 2013, the first subject was treated in our new Israeli study of MDMA-assisted psychotherapy for PTSD. This study will enroll 10 subjects with chronic, treatment-resistant PTSD, some of whom will be referred by the Israeli Defense Forces. This study is taking place at Beer Yaakov Mental Hospital, and is led by Principal Investigator Moshe Kotler, M.D. http://www.maps.org/media/view/canada_nine_grams_of_mdma_arrive_in_canada_after_four-year_delay/ http://www.maps.org/media/view/canada_nine_grams_of_mdma_arrive_in_canada_after_four-year_delay/#When:18:50:08Z On April 16, 2013, the nine grams of MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD arrived at the study pharmacy. Our efforts to start the study began in 2007, and we began seeking the import permit after Health Canada approved the protocol in March 2009. The Canadian pharmacist worked for more than 2½ years to make the security adjustments to the pharmacy required by Health Canada for the import permit. We are now preparing to submit a series of minor protocol amendments to Health Canada and to the Canadian Institutional Review Board. Once these amendments are approved, which could take several weeks to several months, we will begin screening and treating subjects. http://www.maps.org/media/view/canada_mdma_shipped_from_switzerland_to_canada_after_2-year_delay/ http://www.maps.org/media/view/canada_mdma_shipped_from_switzerland_to_canada_after_2-year_delay/#When:18:43:07Z On April 8, 2013, the nine grams of MDMA to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD were exported from Switzerland to Canada. The Canadian pharmacist worked for more than 2½ years to make the security adjustments to the pharmacy required by Health Canada for the import permit. MAPS’ efforts to design the protocol, receive all necessary approvals, and conduct the study began in 2007. Once the MDMA arrives at the study pharmacy after clearing customs, we will submit a series of minor protocol amendments to Health Canada and to the Canadian Institutional Review Board. Once the amendments are approved, which could take several weeks, we will begin screening and treating subjects. Co-Principal Investigator Andrew Feldmár will give an update on training future psychedelic therapists at Psychedelic Science 2013, after U.S. Embassy finally granted him permission to enter the country after banning him for writing about psychedelic experiences he had 40 years ago. http://www.maps.org/media/view/u.s._boulder_study_irb_approves_amended_protocol_site_prepares_for_subject_/ http://www.maps.org/media/view/u.s._boulder_study_irb_approves_amended_protocol_site_prepares_for_subject_/#When:18:48:30Z On April 5, 2013, an independent Institutional Review Board (IRB) approved the amended protocol and informed consent documents for our soon-to-be-initiated study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The amended protocol includes new study measures (the Dissociative Experience Scale II/DES-II and a Visual Analog Scale for Somatic Symptoms) and updated dosage information. We have also added additional study staff, including a new therapist and intern therapist. The FDA will now review the IRB-approved amended protocol while the site prepares to begin screening subjects. Principal Investigator Marcela Ot’alora will give an update on the study’s progress at Psychedelic Science 2013. http://www.maps.org/media/view/u.s._veterans_study_second_firefighter_receives_mdma-assisted_psychotherapy/ http://www.maps.org/media/view/u.s._veterans_study_second_firefighter_receives_mdma-assisted_psychotherapy/#When:21:37:51Z On March 2, 2013, the 13th subject of 24 received their first experimental session in our ongoing study of MDMA-assisted psychotherapy for veterans, firefighters, and police officers with service-related PTSD. This subject is the second firefighter with chronic, treatment-resistant PTSD to be enrolled in this study. Join Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., for a full-day workshop on Thursday, April 18 at Psychedelic Science 2013. http://www.maps.org/media/view/social_anxiety_in_autistic_adults_protocol_submitted_to_fda/ http://www.maps.org/media/view/social_anxiety_in_autistic_adults_protocol_submitted_to_fda/#When:21:38:13Z On February 28, 2013, the protocol (full protocol | synopsis) for our planned study of MDMA-assisted therapy for social anxiety in autistic adults was submitted to the U.S. Food and Drug Administration for review. This will be a MAPS-sponsored collaborative study between Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the Stanford University School of Medicine. Social anxiety is prevalent in autistic adults, and often compounds the considerable social challenges faced by autistic adults. The main objective of this study is to collect data on the safety of MDMA-assisted therapy in autistic adults, and to use standard clinical measures to estimate the extent to which MDMA-assisted therapy may reduce social anxiety symptoms in this group. Even though we did attempt to obtain external funding from a private foundation, our letter of intent was rejected. Please consider donating to help complete this study. Alicia Danforth, Ph.D.(c), will present the results of her research on the MDMA experiences of adults on the autism spectrum on Saturday, April 20 at Psychedelic Science 2013. http://www.maps.org/media/view/u.s._boulder_study_dea_approves_schedule_i_license_for_study_physician/ http://www.maps.org/media/view/u.s._boulder_study_dea_approves_schedule_i_license_for_study_physician/#When:03:37:56Z On February 21, 2013, the U.S. Drug Enforcement Administration approved the Schedule I license for the psychiatrist for our new study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The Schedule I license allows the study psychiatrist to store and administer the MDMA to be used in the study. The license was issued just one day after a favorable recommendation was sent to the DEA national headquarters by the agency’s Denver field office. We have now obtained all necessary approvals and can initiate the study months sooner than anticipated. In contrast, we waited about five months for the DEA issue a Schedule I license to Dr. Michael Mithoefer, the lead investigator of our ongoing study in U.S. veterans, and seven months to issue his Schedule I license for our therapist training protocol. According to MAPS executive director Rick Doblin, Ph.D., “When DEA headquarters processes a Schedule I license for MDMA/PTSD research in just one day, anything seems possible.”