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 13:52:11 -0600 http://www.maps.org/media/view/mdma-assisted_psychotherapy_relapse_study_initiated/ http://www.maps.org/media/view/mdma-assisted_psychotherapy_relapse_study_initiated/#When:22:18:47Z On January 16, 2012, the official study initiation took place for our upcoming relapse study of MDMA-assisted psychotherapy for PTSD. The first subject will be enrolled shortly thereafter. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again free these subjects from a diagnosis of PTSD. This study is the first time we are offering an additional MDMA-assisted psychotherapy session after a considerable amount of time has passed (up to 64 months) after completing assessments following the initial therapy.   http://www.maps.org/media/view/protocol_design_completed_for_new_australian_study_of_mdma-assisted_ps/ http://www.maps.org/media/view/protocol_design_completed_for_new_australian_study_of_mdma-assisted_ps/#When:21:16:00Z On January 8, 2012, our clinical team finalized the basic design of the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The study, which will be led by Clinical Investigators Dr. Stuart Saker, MBBS, and Fiona MacKenzie, MPsych(Clinical), will compare the effectiveness of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD using two different dosages of MDMA: a full dose of 125mg (with a supplemental 62.5mg) and a low dose of 30mg (with a supplemental 15mg). Seven subjects will be allocated to the full dose condition, with the remaining five to the low dose condition. Subjects in this study will receive two experimental sessions instead of three, enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies. The lead investigators both completed MAPS’ training course for MDMA-assisted psychotherapy researchers, which took place in Israel last January. The protocol will be submitted to an Independent Human Research Ethics Committee (HREC) by February 8, and to the Australian Therapeutic Goods Administration (TGA) once it has been approved. MAPS has pledged $25,000 to this study, which the researchers already matched with their own $75,000. We are now offering an additional $25,000 if they can raise an additional $75,000 in matching funds. http://www.maps.org/media/view/contracts_finalized_for_israeli_study_of_mdma-assisted_psychotherapy_for_pt/ http://www.maps.org/media/view/contracts_finalized_for_israeli_study_of_mdma-assisted_psychotherapy_for_pt/#When:22:24:17Z On December 25, 2011, MAPS and the Research Fund at Beer Ya’akov Mental Hospital finalized the contracts for our upcoming Israeli study of MDMA-assisted psychotherapy for PTSD. The Ethics Committee at Beer Ya’akov Mental Hospital approved the insurance certificate for the study on November 29, which was the final document required prior to finalizing the study contract. The Ministry of Health and the Ethics Committee has already approved the protocol. The second of three Israeli therapists have received MDMA in our therapist training protocol, with the third to receive MDMA in a few weeks. Our clinical team is now preparing for a study kick-off meeting with the site to prepare for screening Israeli subjects. http://www.maps.org/media/view/mdma-assisted_psychotherapy_intern_study_protocol_under_development/ http://www.maps.org/media/view/mdma-assisted_psychotherapy_intern_study_protocol_under_development/#When:22:23:13Z On December 9, 2011, the MAPS clinical team met with the site team at Cartographie Psychedelica to plan for our planned intern study of MDMA-assisted psychotherapy for PTSD. This study will investigate the effectiveness of MDMA-assisted psychotherapy when one member of the standard male/female co-therapist team is a healthcare intern. The study will be led by Marcela Ot’alora G., M.A., L.P.C., and will take place in Boulder, CO. At the December 9 meeting, the clinical team began planning for a visit to the study site, and made some final adjustments to the study design. The team discussed the logistics of the trial site and Schedule I license application, reviewed investigator responsibilities according to Good Clinical Practice (GCP) guidelines, and determined how investigators could best prepare themselves for conducting the study. The protocol design stage has now been completed, and documents are being prepared for submission to FDA and Institutional Review Board. Discussions are underway for scheduling a five-day therapist training seminar for the Boulder team. http://www.maps.org/media/view/mdma-assisted_psychotherapy_for_autism_study_proposals_accepted_until_decem/ http://www.maps.org/media/view/mdma-assisted_psychotherapy_for_autism_study_proposals_accepted_until_decem/#When:16:26:16Z We are welcoming proposals for a MAPS-sponsored pilot study of MDMA for Asperger’s syndrome and Autism Spectrum Disorders from interested researchers until December 16. A number of people with high-functioning autism and Asperger’s Syndrome have reported improvements after taking MDMA outside of research contexts. MDMA shows promise for treating Autism Spectrum Disorders since the effects of MDMA that increase empathy and enhance communication are precisely the abilities that autism tends to degrade. MAPS is offering a grant of $10,000 for protocol development expenses for this pilot study. We have prepared a Request for Proposals (RFP) for researchers based in the U.S. We’re looking for an established research team that would also have a good chance of obtaining funds for research from other grant agencies, as autism research is currently a well-funded field. At present, we have not yet raised funds for the study itself, but we do have funds for protocol development. Once we have a completed protocol, we will develop a budget and a fundraising plan. We will also work to raise additional funds through MAPS and perhaps other sources. To facilitate the protocol development process, MAPS has collected numerous anecdotal reports from individuals with Autism Spectrum Disorders who have used MDMA. Many of these accounts are from people who considered MDMA to be helpful. If you or someone you know has heard of MDMA having either positive or negative effects on symptoms of Autism Spectrum Disorders or Asperger’s syndrome, we would like to hear from you. Please contact MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., at berra@maps.org. http://www.maps.org/media/view/health_canada_requests_additional_changes_to_canadian_mdma_ptsd_study_pharm/ http://www.maps.org/media/view/health_canada_requests_additional_changes_to_canadian_mdma_ptsd_study_pharm/#When:22:25:55Z On December 2, 2011, Health Canada sent a report of the results of their second security inspection to the manager of the pharmacy where the MDMA will be stored for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. The report summarizes several changes that will be needed at the pharmacy before Health Canada grants it the license to store the study MDMA. These include (1) the installation of an additional alarm system for the area surrounding the safe, (2) the reinforcement of the windows, door, and lock to the room containing the safe, and (3) the addition of the words “Restricted Drug” to the MDMA label. Health Canada requested additional information after their initial May 10 inspection, after which a follow-up took place on October 18. A third security inspection will be scheduled once we have made the required changes to the pharmacy site. The creation of additional security regulations following the initial inspection has delayed the security clearance, and therefore the study initiation, by almost six months. The process of meeting the security requirements of Health Canada is exceedingly frustrating. At times, the amount of security required for about $1500 of MDMA seems absurd, as compared to security for other items at the pharmacy worth much more. Nevertheless, our policy is still to comply with whatever is required and to continue to persevere until we are able to start this study. http://www.maps.org/media/view/u.s._veterans_study_of_mdma-assisted_psychotherapy_for_ptsd_screens_eighth_/ http://www.maps.org/media/view/u.s._veterans_study_of_mdma-assisted_psychotherapy_for_ptsd_screens_eighth_/#When:22:16:25Z On December 1, 2011, the eighth (out of 16) veteran passed in-person screening for participation in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with PTSD. Five subjects have now been enrolled and treated, and have entered the long-term follow-up portion of the study, which will last twelve months following their final experimental treatment session. As of January 9, our clinical team had received 172 inquiries about participation in the study, emphasizing the widespread need among veterans for more effective treatments for PTSD resulting from military service. We are now seeking an additional $250,000 to expand this study from 16 subjects to 24. http://www.maps.org/media/view/new_mdma_ptsd_training_videos_under_development/ http://www.maps.org/media/view/new_mdma_ptsd_training_videos_under_development/#When:19:29:30Z Two essential parts of conducting methodologically rigorous and state-of-the-art MDMA-assisted psychotherapy research are standardizing the method of MDMA-assisted psychotherapy itself and the method by which data is collected about subjects’ PTSD symptoms. We have standardized our treatment in our MDMA-assisted psychotherapy treatment manual and related adherence criteria. Having a consistent, reliable way to measure PTSD symptoms at baseline and over time during and after treatment is also essential. MAPS has recently completed the development of a training manual for independent raters who conduct the Clinician-Administered PTSD Scale (CAPS) interviews in our international series of Phase 2 MDMA/PTSD pilot studies. The CAPS is the primary measure used by clinicians and therapists worldwide for evaluating the severity of PTSD symptoms, and is the principle measure we use to assess the effectiveness of our treatment method. The CAPS training manual will be supplemented by video tutorials of CAPS interviews, drawn from actual recordings of interviews with subjects enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD in veterans of war. By building on the training materials provided by the U.S. Veterans Administration, creating Hebrew and Arabic versions of the CAPS through rigorous double back translation methods, and providing a uniform set of training tools for independent raters, we will be able to standardize how the CAPS is administered across study sites. This is a necessary step before moving on to the larger Phase 3 studies required for federal approval of MDMA-assisted psychotherapy as a legal treatment for PTSD. http://www.maps.org/media/view/two_more_subjects_pass_in-person_screening_for_u.s._mdma_ptsd_veterans_stud/ http://www.maps.org/media/view/two_more_subjects_pass_in-person_screening_for_u.s._mdma_ptsd_veterans_stud/#When:19:27:29Z As of October 21, 2011, our ongoing Phase 2 study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD has enrolled five out of 16 subjects. Three subjects have started the long-term follow-up portion of the study, and two are still in treatment. Two additional veterans have passed in-person screening, involving thorough assessments of PTSD severity and medical eligibility, with their treatment sessions soon to be scheduled. One subject has chosen to discontinue treatment after just one experimental MDMA-assisted psychotherapy session, reporting being cured and needing no further sessions. http://www.maps.org/media/view/health_canada_conducts_follow-up_pharmacy_inspection_for_mdma_ptsd_stu/ http://www.maps.org/media/view/health_canada_conducts_follow-up_pharmacy_inspection_for_mdma_ptsd_stu/#When:16:01:26Z On October 18, 2011, Health Canada conducted a follow-up inspection of the pharmacy for our planned Phase 2 Canadian study of MDMA-assisted psychotherapy for PTSD. We expect that Health Canada will report on the results of this inspection within four to six weeks. Frustratingly, even though we followed Health Canada’s exact written requirements, the requirements have now changed and additional security measures may be needed. This will delay the start of the study for several additional months. The pharmacy inspection is required under Canadian regulations to ensure that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. Once we obtain clearance from Health Canada we will be able to import the MDMA for the study into Canada from Switzerland. We’ve done everything Health Canada requested in their written communication but the inspector has now stated that new regulations have been created and that we may need to comply with them as well. The inspector said that she will submit her report to officials in Ottawa, and that we should hear back from Health Canada by the end of November. We have now been told we will receive the report the first or second week of December. Some of the changes that may be necessary could be to replace the glass door to the pharmacy with a solid wood or metal door and to replace the windows of the room with shatterproof/bulletproof glass. We haven’t heard back from Health Canada yet about their verdict, but the video certainly shows the lengths to which the pharmacy has gone to protect the MDMA supply. The lead investigator for this study, Ingrid Pacey, M.D., will speak on the MDMA-Assisted Psychotherapy for PTSD Research Panel at our 25th anniversary conference this December. Watch this brief video made by Canadian documentary filmmaker Arwen Hunter featuring a personal interview with pharmacist Colin Holyk discussing the challenges of negotiating the strict security requirements required by Health Canada and for a look inside the Vancouver pharmacy where the MDMA will be stored.