Multidisciplinary Association For Psychedelic Studies

MEDICAL RESEARCH AND EDUCATION

IN 2022, MAPS WAS THE SPONSOR OF CLINICAL TRIALS STUDYING INVESTIGATIONAL MDMA-ASSISTED THERAPY FOR PTSD AND FUNDER OF REGULATORY ACTIVITIES SUPPORTING THE PROPOSED NEW DRUG APPLICATION (NDA) SUBMISSION TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). THE SECOND PHASE 3 TRIAL THAT BEGAN IN NOVEMBER 2020 CONTINUED TO ENROLL PARTICIPANTS AT 13 SITES IN THE U.S. AND ISRAEL UNTIL APRIL 2022. THE TRIAL ENROLLED PARTICIPANTS WITH MODERATE-TO-SEVERE PTSD WHO WERE AT LEAST 18 YEARS OLD. THIS PHASE 3 STUDY PROTOCOL, ALONG WITH THE OTHER TRIALS IN THE CLINICAL PROGRAM, WERE DEVELOPED IN COLLABORATION WITH THE FDA. THE FINAL DATA POINT WAS COLLECTED IN NOVEMBER 2022. AT THE END OF 2022, THE COLLECTED DATA WAS ANALYZED WITH THE INTENTION OF DEVELOPING A MANUSCRIPT TO SUBMIT TO A PEER-REVIEW JOURNAL.MAPS PBC COMPLETED ENROLLMENT FOR MT1, A STUDY THAT COMPARED THE EFFECTS OF MDMA-ASSISTED THERAPY AND THERAPY WITH PLACEBO ON MOOD AND PSYCHOLOGICAL EXPERIENCE IN PEOPLE TRAINED TO PRACTICE INVESTIGATIONAL MDMA-ASSISTED THERAPY. THE FINAL DATA POINT WAS COLLECTED IN JULY 2022.IN PREPARATION FOR SUBMITTING THE NDA TO THE FDA, MAPS PBC INITIATED PREPARATION OF CLINICAL STUDY REPORTS FOR 17 MAPS-SPONSORED CLINICAL TRIALS OF INVESTIGATIONAL MDMA-ASSISTED THERAPY FOR THE TREATMENT OF PTSD IN ADULTS AND HEALTHY VOLUNTEERS. GIVEN THE IMPORTANCE OF ACCESS TO THE INVESTIGATIONAL THERAPY IF IT IS APPROVED, MAPS PBC BEGAN DISCUSSIONS WITH THE AMERICAN MEDICAL ASSOCIATION TO DEVELOP A CURRENT PROCEDURAL TERMINOLOGY CODE TO PROVIDE A POTENTIAL PATHWAY FOR REIMBURSEMENT FOR PSYCHEDELIC-ASSISTED THERAPIES. DISCUSSIONS WITH THE VETERANS ADMINISTRATION CONTINUED, WITH THE PURPOSE OF EXPANDING RESEARCH AT VA HEALTH CARE SYSTEM FACILITIES.MAPS CONDUCTED PUBLIC EDUCATION THROUGH PRESENTATIONS AT DOZENS OF PUBLIC CONFERENCES AND WEBINARS, PUBLISHING OUR FREE TRI-ANNUAL BULLETIN IN PRINT AND ONLINE, PUBLISHING EDUCATIONAL ARTICLES ON WEBSITES AND SOCIAL MEDIA CHANNELS, AND PUBLISHING BOOKS IN THE TRADE. IN 2022, MAPS EDUCATED MILLIONS THROUGH PROVIDING INTERVIEWS FOR HUNDREDS OF UNIQUE MEDIA EXPOSURES FROM ONLINE, BROADCAST, AND PRINT PUBLICATIONS INCLUDING NPR, CNN, NBC, CBS, ABC, TIME, NEWSWEEK, FORBES, ROLLING STONE, THE NEW YORK TIMES, THE WASHINGTON POST, FOX NEWS, STARS AND STRIPES, MILITARY TIMES, REUTERS, AND MANY MORE.THE ZENDO PROJECT'S PSYCHEDELIC HARM REDUCTION PROGRAM'S IN-PERSON SERVICES WERE PROVIDED AT BURNING MAN AND INCLUDED TRAINING VOLUNTEERS WHO PROVIDED PEER SUPPORT SERVICES TO MORE THAN 600 INDIVIDUALS HAVING CHALLENGING PSYCHOLOGICAL EXPERIENCES. MAPS STAFF FACILITATED THE ZENDO PROJECT'S TRANSITION IN ITS EFFORT TO BECOME AN INDEPENDENT 501(C)(3) IN 2023.