MULTIDISCIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES
Programs
Program 1 [2018]
IN FY18, MAPS' PRIMARY FOCUS WAS ON PREPARING FOR ITS MULTI-SITE PHASE 3 CLINICAL TRIALS OF MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD, WHICH FINALLY BEGAN RECRUITMENT IN NOVEMBER 2018. THE RESEARCH WILL TAKE PLACE AT 14 SITES (LISTED BELOW) AND ENROLL 100-150 VOLUNTEERS WITH SEVERE PTSD. VOLUNTEERS MUST BE AT LEAST 18 YEARS OLD AND HAVE BEEN DIAGNOSED WITH PTSD, AND MUST BE IN GOOD PHYSICAL HEALTH TO PARTICIPATE. THIS WILL BE THE FIRST OF TWO PHASE 3 TRIALS OF MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD CONDUCTED UNDER U.S. FOOD AND DRUG ADMINISTRATION (FDA) GUIDELINES. THE SECOND TRIAL WILL TAKE PLACE AFTER AN INTERIM ANALYSIS OF THE DATA FROM THE FIRST TRIAL, AND WILL ENROLL AN ADDITIONAL 100-150 PARTICIPANTS. EUROPEAN TRIALS ARE PLANNED TO START IN 2019.ON JULY 28, 2017, MAPS SUCCESSFULLY COMPLETED THE FDA'S SPECIAL PROTOCOL ASSESSMENT (SPA) PROCESS AND RECEIVED AN AGREEMENT LETTER REGARDING ITS PHASE 3 MDMA/PTSD PROTOCOL DESIGN. THIS AGREEMENT CONFIRMS THAT THE PROTOCOL DESIGN, CLINICAL ENDPOINTS, PLANNED CONDUCT, AND STATISTICAL ANALYSES FOR THE PHASE 3 TRIALS ARE ACCEPTABLE TO SUPPORT REGULATORY APPROVAL BY THE FDA. IF MAPS OBTAINS STATISTICALLY SIGNIFICANT RESULTS IN PHASE 3 AND THERE ARE NO NEW SAFETY ISSUES, FDA IS COMMITTED IN WRITING TO APPROVING MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD AS A TREATMENT LEGALLY-AVAILABLE BY PRESCRIPTION. ON AUGUST 15, 2017, FDA DESIGNATED MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD AS A BREAKTHROUGH THERAPY, THE MOST VALUABLE PROGRAM FDA OFFERS FOR THE MOST PROMISING DRUGS.IN LATE DECEMBER 2017, MAPS HAD PRELIMINARY, PROMISING DISCUSSIONS WITH FDA AND DEA ABOUT THE ESTABLISHMENT OF A SPECIAL EXPANDED ACCESS PROGRAM, ALSO KNOWN AS COMPASSIONATE USE. THIS EXPANDED ACCESS PROGRAM ALLOWS TREATMENT-RESISTANT PATIENTS 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. THE PROGRAM IS DESIGNED TO ADDRESS URGENT AND LIFE-THREATENING CONDITIONS IN PATIENTS WHO HAVE CURRENTLY FAILED TO OBTAIN RELIEF WITH EXITING TREATMENT OPTIONS. MAPS LEARNED THAT FDA APPROVES OVER 98% OF APPLICATIONS FOR EXPANDED ACCESS AND DEA INDICATED THAT IT WOULD BE WILLING AND ABLE TO REVIEW SCHEDULE 1 LICENSE APPLICATIONS FROM 100 OR MORE APPLICATIONS FOR EXPANDED ACCESS SITES. IN THE FIRST FEW MONTHS OF 2019, MAPS SUBMITTED ITS EXPANDED ACCESS PROTOCOL TO FDA FOR REVIEW AND IS NOW AWAITING FINAL APPROVAL.ALSO IN DECEMBER 2017, AN ANONYMOUS BITCOIN PHILANTHROPIST CREATED THE PINEAPPLE FUND, WITH THE MISSION TO DONATE 5057 BITCOINS (THEN WORTH ABOUT $86 MILLION) TO WORTHY NONPROFITS AND PROJECTS. IN DECEMBER 2017, THE PINEAPPLE FUND DONATED $1 MILLION IN BITCOIN TO MAPS FOR ITS PHASE 3 MDMA/PTSD RESEARCH, AND THEN IN JANUARY 2018 OFFERED A $4 MILLION MATCHING GRANT, WHICH WAS MET ON MARCH 9, 2018 FROM A VARIETY OF DONORS, MANY FIRST-TIME. SOME OF THESE PLEDGES INCLUDED $2 MILLION OVER THREE YEARS FROM CODY SWIFT OF THE RIVERSTYX FOUNDATION; $1 MILLION FROM BRITT SELVITELLE, FORMER TWITTER ENGINEER; $1 MILLION OVER FOUR YEARS FROM THE SARLO FOUNDATION; AND $1 MILLION OVER FOUR YEARS FROM REBEKAH MERCER. ADDITIONALLY, MAPS RECEIVED OVER $800,000 WORTH OF LUN TOKENS FROM AN ANONYMOUS DONOR; $1 MILLION IN BITCOIN FROM AN ANONYMOUS DONOR; AND $1 MILLION IN BITCOIN FROM JAMES EVANS.MAPS ALSO COMPLETED ITS STUDY LOOKING AT THE SAFETY AND EFFICACY OF USING MDMA-ASSISTED PSYCHOTHERAPY FOR SOCIAL ANXIETY IN ADULTS ON THE AUTISM SPECTRUM, WITH THE PAPER RECENTLY PUBLISHED IN JOURNAL OF PSYCHOPHARMACOLOGY, AND COMPLETED ITS STUDY OF MDMA-ASSISTED PSYCHOTHERAPY FOR END-OF-LIFE ANXIETY, WITH THE PAPER AWAITING PEER REVIEW. MAPS ALSO CONTINUED ITS STUDY BLENDING MDMA-ASSISTED PSYCHOTHERAPY WITH COGNITIVE BEHAVIORAL CONJOINT THERAPY (CBCT) AND ITS STUDY BLENDING MDMA-ASSISTED PSYCHOTHERAPY WITH PROLONGED EXPOSURE THERAPY (PE). MARIJUANA RESEARCH CONTINUED IN FY18. AFTER SEVEN YEARS OF STRUGGLE, MAPS FINALLY RECEIVED DEA AND IRB APPROVAL IN FY16 TO MOVE FORWARD WITH ITS STUDY EXAMINING THE THE EFFICACY OF SMOKED MARIJUANA IN 76 VETERANS WITH CHRONIC, TREATMENT-RESISTANT PTSD. THIS RESEARCH IS FUNDED BY A $1.156 MILLION GRANT FROM THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVRIONMENT (CDPHE). IN FEBRUARY 2017, THE FIRST PARTICIPANT WAS ENROLLED AND RECEIVED CANNABIS. THE STUDY CONCLUDED IN 2019 AND IS SCIENTIFIC PAPER WILL SOON BE COMPLETED AND SUBMITTED FOR PEER REVIEW AND PUBLICATION.GeographiesNot indicatedDatesJun 1, 2017 – May 31, 2018Source990No causes providedNo populations provided–$1.2MProgram 2 [2018]
EDUCATION EXPENSES INCLUDE EVENTS, CONFERENCES, PUBLICATIONS, COMMUNICATIONS, AND PSYCHEDELIC HARM REDUCTION.ADDITIONALLY, IN FY18, MAPS PROVIDED SPONSORSHIP, SPEAKERS, TABLES, FORMAL REPRESENTATIVES, AND/OR PROMOTIONAL SUPPORT FOR 70 OUTREACH EVENTS.MAPS' COMMUNICATIONS INCLUDE ACTIVE ENGAGEMENT IN PUBLIC EDUCATION THROUGH MEDIA CONTACTS, WEBSITE AND SOCIAL MEDIA PRESENCE, PUBLISHING THREE MAPS BULLETINS, 12 EMAIL NEWSLETTERS, AND SEVERAL BOOKS. MAPS MAINTAINS NUMEROUS WEBSITES, INCLUDING MAPS.ORG, MDMAPTSD.ORG, MDMAAUTISM.ORG, MAPSCANADA.ORG, PSYCHEDELICSCIENCE.ORG, PSYCHEDELICDINNERS.ORG, MAPSBCORP.COM, AND ZENDOPROJECT.ORG. IN FY18, MAPS RECEIVED 549 UNIQUE MEDIA MENTIONS FROM ONLINE AND PRINT PUBLICATIONS. MEDIA OUTLETS INCLUDE: TIME, FORBES, ROLLING STONE, NEW YORK MAGAZINE, THE WASHINGTON POST, PLAYBOY, THE NEW YORK TIMES, FOX NEWS, BREITBART, STARS AND STRIPES, REUTERS, THE SAN FRANCISCO CHRONICLE, AND MANY MORE.THE ZENDO PROJECT PSYCHEDELIC HARM REDUCTION PROGRAM EXPERIENCED CONTINUED EXPANSION OF SERVICES IN FY18. THE ZENDO PROJECT PROVIDED SERVICES AT OVER SEVEN MAJOR FESTIVALS INCLUDING: BURNING MAN, INSOMNIAC EVENTS WITH PROJECT OPEN TALK, ENVISION, AND LIGHTNING IN A BOTTLE. THE ZENDO PROJECT PROVIDED SUPPORT TO 670 GUESTS AT TWO LOCATIONS AT BURNING MAN 2017. ZENDO'S LOCATION WAS HIGHLIGHTED ON BURNING MAN'S OFFICIAL MAP OF BLACK ROCK CITY AND ZENDO COLLABORATED CLOSELY WITH MEDICAL STAFF, LAW ENFORCEMENT FROM THE BUREAU OF LAND MANAGEMENT, AND BLACK ROCK CITY RANGERS. A PUBLIC THREE-HOUR TRAINING ON THE PRINCIPLES OF PSYCHEDELIC HARM REDUCTION WAS HOSTED FOR SEVERAL HUNDRED PEOPLE. ZENDO STAFF ALSO HOSTED TWO INTEGRATION SESSIONS.GeographiesNot indicatedDatesJun 1, 2017 – May 31, 2018Source990No causes providedNo populations provided–$1.6MMDMA-Assisted Therapy Clinical Trials
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. IN 2023, THE COLLECTED DATA WAS ANALYZED INTO A MANUSCRIPT AND SENT TO A PEER-REVIEW JOURNAL.GeographiesNot indicatedDatesJan 1, 2023 – Dec 31, 2023Source990No causes providedNo populations provided–$9M
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