Multidisciplinary Association For Psychedelic Studies

MEDICAL RESEARCH AND EDUCATION

IN 2021, MAPS PRIMARILY FOCUSED ON SPONSOR ACTIVITIES RELATED TO ITS TWO MULTI-SITE PHASE 3 CLINICAL TRIALS OF MDMA-ASSISTED THERAPY FOR PTSD HOSTED AT SITES IN THE U.S., CANADA, AND ISRAEL. PEER-REVIEWED RESULTS OF THE FIRST PHASE 3 TRIAL WERE PUBLISHED IN NATURE MEDICINE IN MAY 2021 AND LATER NAMED AMONG THE TOP TEN BREAKTHROUGHS OF THE YEAR BY THE JOURNAL SCIENCE. THE SECOND PHASE 3 TRIAL BEGAN ENROLLMENT AT 13 SITES IN THE U.S. AND ISRAEL IN NOVEMBER 2020; THE FINAL DATA POINT IS EXPECTED TO BE COLLECTED IN NOVEMBER 2022. VOLUNTEERS WERE PEOPLE DIAGNOSED WITH MODERATE TO SEVERE, CHRONIC PTSD WHO WERE AT LEAST 18 YEARS OLD AND IN GOOD PHYSICAL HEALTH. THE TWO PHASE 3 TRIALS OF MDMA-ASSISTED THERAPY FOR PTSD ARE CONDUCTED UNDER U.S. FOOD AND DRUG ADMINISTRATION (FDA) GUIDELINES. IN 2020, MAPS BEGAN RECRUITMENT FOR A PHASE 2 TRIAL OF MDMA-ASSISTED THERAPY FOR PTSD IN EUROPE, AND THE FIRST PARTICIPANT WAS TREATED IN 2021. IN LATE 2017, MAPS BEGAN PRELIMINARY, PROMISING DISCUSSIONS WITH FDA AND DEA ABOUT THE ESTABLISHMENT OF A SPECIAL EXPANDED ACCESS PROGRAM, ALSO KNOWN AS COMPASSIONATE USE. THE PROGRAM IS DESIGNED TO ADDRESS URGENT AND LIFE-THREATENING CONDITIONS, IN PATIENTS WHO HAVE CURRENTLY FAILED TO OBTAIN RELIEF WITH EXITING TREATMENT OPTIONS, TO USE AN INVESTIGATIONAL TREATMENT ON A COMPASSIONATE BASIS AT THEIR OWN RISK AND AT THEIR OWN COST WHILE THE PHASE 3 STUDIES FOR THAT TREATMENT ARE STILL ONGOING. IN 2020, THE FDA APPROVED MAPS' EXPANDED ACCESS PROTOCOL FOR 50 SUBJECTS WITH TREATMENT-RESISTANT PTSD AND IN 2021, PATIENT SCREENING FOR THE PROGRAM BEGAN.EIGHT HUNDRED THERAPISTS COMPLETED THE 100-HOUR MDMA THERAPY TRAINING PROGRAM IN 2021, AND ADDITIONAL THERAPISTS IN OUR TRAINING PROGRAM COMPLETED THEIR CONSULTATION AND CLINICAL EXPERIENCE CRITERIA BY TREATING ONE PTSD PATIENT IN AN OPEN-LABEL PROTOCOL PROVIDING THE SAME TREATMENT DESIGN AS IN OUR PHASE 3 STUDY. MAPS' THERAPIST TRAINING TEAMS VIEWED VIDEOTAPES OF THE THERAPY SESSIONS AND PROVIDED SUPERVISION AND FEEDBACK TO THE THERAPISTS ON HOW WELL THEY WERE ADHERING TO OR TREATMENT MANUAL FOR MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD. MAPS ENROLLED ADDITIONAL THERAPISTS IN OUR THERAPIST TRAINING PROTOCOL, MT1. IN THIS PROTOCOL, THERAPISTS IN OUR TRAINING PROGRAM CAN VOLUNTEER TO FULFILL THEIR EXPERIENTIAL ELECTIVE BY RECEIVING MDMA IN A THERAPEUTIC SETTING ADMINISTERED BY TWO CO-THERAPISTS FROM OUR THERAPIST TRAINING TEAM.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 EIGHT WEBSITES AND SOCIAL MEDIA CHANNELS, AND BOOKS IN THE TRADE. IN 2021, 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 CURTAILED DUE TO COVID-19. ZENDO PROJECT STAFF LEAD EFFORTS TO DEVELOP PILOT COMMUNITY- AND INSTITUTION-BASED HARM REDUCTION EDUCATION, PARTICULARLY FOR FIRST RESPONDERS, AND ONLINE PUBLIC EDUCATION PROGRAMS. ZENDO PROJECT EXPERTS DELIVERED TRAINING PROGRAMS FOR PEER-TO-PEER HARM REDUCTION PROVIDERS AND PRESENTED AT CONFERENCES.MAPS SERVED AS FISCAL SPONSOR TO ABOUT THREE DOZEN ENTITIES, PROVIDING ADMINISTRATIVE STRUCTURE AND A MECHANISM TO RECEIVE CHARITABLE DONATIONS. EACH ENTITY -- WHICH MAY BE EITHER A LIMITED-TERM PROJECT OR A NON-PROFIT STARTUP SEEKING (OR LIKELY TO SEEK) INDEPENDENT 501(C)(3) STATUS -- HAS A MISSION RELATED TO MAPS'.