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 Thu, 24 May 12 21:28:01 -0500 http://www.maps.org/media/view/u.s._veterans_study_revised_budget_completed_seventh_subject_treated/ http://www.maps.org/media/view/u.s._veterans_study_revised_budget_completed_seventh_subject_treated/#When:22:02:49Z The seventh subject out of 24 has now received their first MDMA-assisted psychotherapy session in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD. We have expanded the study from 16 to 24 subjects, added the possibility of enrolling local firefighters and police officers with work-related PTSD, and revised and updated the budget to accommodate the study expansion. This study has been ongoing for the past two years, and has an estimated two additional years before completion. We have incorporated into this budget more precise cost estimates based on a review of the actual costs of treating the initial subjects. The total estimated budget for this study is $1.25 million. We have already $600,000, and are seeking to raise the additional $650,000 to complete this study. The revised budget for this crucial study represents a further professionalization in MAPS’ clinical research procedures. MAPS Director of Clinical Research Amy Emerson created a new budget template for our clinical studies, based on her extensive experience budgeting and monitoring multi-site clinical studies for Novartis. The updated budget distinguishes between start-up costs, site- and procedure-specific patient costs, and internal MAPS staff costs to enable more accurate budget projections for our larger, multi-site Phase 3 studies. The ability to track expenses on a per-patient, per-procedure basis will allow us to understand the implications of protocol changes on clinical research budgets, and by linking our budget to our outcome data analysis to estimate the impact of budgetary changes on our treatment method and clinical results. http://www.maps.org/media/view/u.s._intern_study_fda_gives_official_go-ahead_for_new_boulder_study/ http://www.maps.org/media/view/u.s._intern_study_fda_gives_official_go-ahead_for_new_boulder_study/#When:16:21:50Z On May 4, 2012, the U.S. Food and Drug Administration notified the MAPS clinical team that our new “intern study” of MDMA-assisted psychotherapy for subjects with PTSD had been cleared for initiation. The study will take place in Boulder, Colorado with Marcela Ot’alora as Principal Investigator. The FDA cleared the study as it was designed, with no changes required prior to initiation. The new study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The use of interns is an effort both to reduce costs and to train the next generation of psychedelic psychotherapists. The study will be initiated once the study physician has received his Schedule I license from the DEA, which we anticipate will take place within the next month. http://www.maps.org/media/view/u.s._intern_study_dea_conducts_inspection_of_mdma_storage_facility/ http://www.maps.org/media/view/u.s._intern_study_dea_conducts_inspection_of_mdma_storage_facility/#When:21:55:09Z On May 3, 2012, an official from the Denver office of the Drug Enforcement Administration conducted an inspection of the safe and facility to be used to store the MDMA for our upcoming intern study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The inspection is required to establish that the MDMA storage site is adequately secure and compliant with federal regulations. However, since the safe was at the study physician’s office rather than where the treatments will take place, it will need to be unbolted from the floor and moved to the treatment location. Once the safe has been moved, a new inspection will be required. Once we have met the DEA’s security requirements, the study physician will be granted his Schedule I license and we will proceed with the study initiation and begin screening subjects. http://www.maps.org/media/view/u.s._relapse_study_first_subject_completes_follow-up_evaluation_after_succe/ http://www.maps.org/media/view/u.s._relapse_study_first_subject_completes_follow-up_evaluation_after_succe/#When:21:51:55Z On April 27, 2012, the first subject completed their follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in two or three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study. The co-therapists for this study are Dr. Michael Mithoefer and Annie Mithoefer, B.S.N., who also conducted the original proof of principle study. The two-month follow-up evaluation revealed that a single additional open-label MDMA-assisted psychotherapy session was sufficient to reduce this subject’s score on the Clinician-Administered PTSD Scale (CAPS) below the diagnostic cutoff for PTSD. The results suggest that people who relapse after the initial series of treatments as a result of additional life stressors could benefit substantially from a single additional MDMA-assisted psychotherapy session. http://www.maps.org/media/view/dea_approves_license_for_mdma_transfer_to_new_storage_facility/ http://www.maps.org/media/view/dea_approves_license_for_mdma_transfer_to_new_storage_facility/#When:22:05:48Z On April 23, 2012, we learned that the U.S. Drug Enforcement Administration had approved the application for a Schedule I MDMA distributor’s license by a contract research firm specializing in synthetic, organic, and medicinal chemistry. This will enable us to transfer the supply of MDMA we use in our U.S. clinical studies to this new facility. The MDMA was originally manufactured in 1985 by Dr. David Nichols at Purdue University, and paid for by MAPS’ predecessor non-profit, Earth Metabolic Design Labs, at a cost of $4/gram. Since Dr. Nichols is retiring from Purdue on June 30, 2012, he will not be able to store the MDMA under his existing Schedule I license after that date. Without an alternative location to store and distribute the MDMA, it would have been destroyed. Our next step is to identify a facility certified under Good Manufacturing Practices (GMP) that can reprocess the MDMA and certify it as compliant with GMP. Phase 3 trials generally require that investigational drugs be compliant with GMP. The alternative would be to pay to have new MDMA manufactured from scratch. Certifying our existing batch of MDMA as GMP would save MAPS the cost of remanufacturing the drug to be used in our remaining Phase 2 and Phase 3 studies, perhaps as much as $200,000. Obtaining GMP certification for MAPS MDMA would enable us to export it around the world for our international studies, though the facilities storing and distributing the MDMA would need to obtain additional licenses. http://www.maps.org/media/view/u.s._proof_of_principle_study_revised_long-term_follow-up_paper_submitted_t/ http://www.maps.org/media/view/u.s._proof_of_principle_study_revised_long-term_follow-up_paper_submitted_t/#When:22:00:48Z On April 16, 2012, Dr. Michael Mithoefer, the lead investigator for our recently completed long-term follow-up of subjects who participated in the initial U.S. proof of principle study, submitted a revised version of the paper in response to comments from reviewers. We’re hopeful the paper will soon be accepted for publication. The long-term follow-up, conducted an average of 3½ years after the last MDMA-assisted psychotherapy session, found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors. http://www.maps.org/media/view/u.s._intern_study_therapist_teams_complete_training_in_south_carolina/ http://www.maps.org/media/view/u.s._intern_study_therapist_teams_complete_training_in_south_carolina/#When:15:31:27Z From April 8-11, 2012, the therapist teams for our MDMA-assisted psychotherapy for PTSD “intern” study completed therapist training in Charleston, South Carolina, with MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. The new intern study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The intern study will take place in Boulder, Colorado, and will be our second clinical trial site in the United States. http://www.maps.org/media/view/u.s._proof_of_principle_study_reviewers_respond_to_long-term_follow-up_pape/ http://www.maps.org/media/view/u.s._proof_of_principle_study_reviewers_respond_to_long-term_follow-up_pape/#When:15:36:28Z On March 27, 2012, reviewers for a scientific journal responded with their comments on the paper describing the results of our long-term follow-up of subjects who participated in our initial U.S. proof of principle study of MDMA-assisted psychotherapy for PTSD. In their comments and feedback, all four reviewers concluded that it was a strong paper that substantially contributed to the existing scientific research on MDMA-assisted psychotherapy for PTSD. We have incorporated the reviewers’ feedback into the paper, which will be resubmitted for publication in the next few days. The study, conducted by lead investigator Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., found that the benefits of MDMA-assisted psychotherapy for PTSD persisted for an average of 3½ years after the last treatment. The study found no evidence of harm associated with the administration of MDMA, either immediately following treatment or during the long-term follow-up. These results are even more important than the remarkable results of our initial proof of principle of study as measured at the two-month follow-up, confirming that the benefits of MDMA-assisted psychotherapy persist over time. http://www.maps.org/media/view/u.s._intern_study_protocol_passes_30-day_fda_review_period_cleared_for_init/ http://www.maps.org/media/view/u.s._intern_study_protocol_passes_30-day_fda_review_period_cleared_for_init/#When:15:32:26Z On March 27, the study protocol for our upcoming U.S. intern study of MDMA-assisted psychotherapy for PTSD was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27.  This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA. http://www.maps.org/media/view/u.s._veterans_study_seventh_subject_enrolled_site_visit_completed/ http://www.maps.org/media/view/u.s._veterans_study_seventh_subject_enrolled_site_visit_completed/#When:15:37:20Z On March 20, 2012, the seventh subject out of 24 was enrolled in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. This study, led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., will enroll 24 U.S. veterans suffering from chronic, treatment-resistant PTSD occurring as a result of war-related PTSD. On March 19-23, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., completed a monitoring visit at the site to ensure data accuracy and compliance with Good Clinical Practice (GCP) guidelines.