MDMA-Assisted Psychotherapy - MAPS

MAPS' highest precedence project is sponsoring Meals and Drug Administration (FDA) drug development analysis into 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the remedy of posttraumatic stress disorder (PTSD). FDA has designated MDMA-assisted therapy for PTSD a Breakthrough Therapy, and has come to settlement with MAPS on Phase three protocol designs after a rigorous Particular Protocol Evaluation (SPA) process. MAPS' goal is to develop MDMA-assisted therapy for PTSD into an FDA-authorised prescription therapy. The Section 3 trials are expected to be full in 2022, that means that FDA may approve the therapy as quickly as 2023. MAPS is also initiating Section 2 trials in Europe.

We're learning whether MDMA-assisted therapy will help heal the psychological and emotional harm attributable to sexual assault, conflict, violent crime, and other traumas. We additionally sponsored completed studies of MDMA-assisted therapy for autistic adults with social anxiety, and MDMA-assisted therapy for anxiety related to life-threatening illnesses.

FDA Agrees to Expanded Access Program for MDMA-Assisted Therapy for PTSD

On December 20, 2019, the U.S. Food and Drug Administration (FDA) agreed to MAPS’ application for an expanded access program for MDMA-assisted therapy for posttraumatic stress disorder (PTSD). The purpose of the expanded access program is to allow early entry to doubtlessly helpful investigational therapies for people facing a critical or life-threatening situation for whom at present out there remedies haven't worked, and who're unable to participate in Phase three clinical trials. This system will enroll 50 PTSD patients at up to 10 sites in the U.S. Site locations will likely be introduced in the subsequent few months.

Expanded access is a U.S. FDA program that permits the use of an investigational drug underneath a Treatment Protocol. The program is designed to deal with urgent and life-threatening circumstances in patients who do not at the moment have promising therapy choices. Only websites throughout the U.S. and U.S. territories are eligible to take part within the U.S. FDA's expanded access program. You may be taught extra about expanded access on the FDA’s web site.

New sites meeting the necessities listed below may search approval to take part in MAPS PBC’s multi-center expanded entry protocol below an FDA Remedy IND, which would permit them to administer open-label MDMA-assisted therapy for PTSD in step with the only permitted protocol. Qualified applicants may have a group of therapy suppliers, a physician, and a facility appropriate to conduct MDMA-assisted therapy per Schedule I regulations with approval by regulatory companies and underneath supervision of MAPS PBC.

buy dmt have now a online coaching software for eligible expanded access websites and suppliers.

Study our MDMA Therapy Coaching Program.

MAPS is endeavor a plan to make MDMA-assisted therapy right into a Meals and Drug Administration (FDA)-permitted prescription treatment by 2023. For-profit pharmaceutical companies usually are not curious about developing MDMA into a medication as a result of the patent for MDMA has expired. The concept of utilizing MDMA to assist therapy of any sort for any specific clinical indication has long been in the general public area.

In MDMA-assisted therapy, MDMA is only administered a couple of times, in contrast to most medications for mental illnesses which are sometimes taken day by day for years, and sometimes ceaselessly.

MDMA isn't the identical as "Ecstasy" or "molly." Substances sold on the road under these names could include MDMA, however frequently also include unknown and/or harmful adulterants. In laboratory studies, pure MDMA has been proven sufficiently safe for human consumption when taken a restricted variety of times in reasonable doses.

Explore MAPS in the Media for the newest headlines.

Learn about MDMA-assisted therapy for social anxiety in autistic adults at mdma-autism.org.

MDMA-Assisted Therapy for PTSD: MAPS-Sponsored Clinical Trials

Ongoing Studies

Expanded Access Program: MDMA-Assisted Therapy for PTSD - Expanded Entry Program Timeline Open-Label Lead-In Examine of MDMA-Assisted Therapy for PTSD (United States and Canada) - Open-Label Lead-In Study Timeline Section 3 Program of MDMA-Assisted Therapy for the Treatment of Extreme PTSD (MAPP2) - Phase three Program Timeline MDMA and Startle Testing Research (Atlanta, Georgia) - Startle Testing Study Timeline U.S. Therapist Training Research (Boulder, Colorado, and Charleston, South Carolina) - U.S. Therapist Training Study Timeline An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Therapy with an Elective fMRI Sub-Research Assessing Changes in Mind Exercise in Subjects with Posttraumatic Stress Disorder (United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands) - An Open-Label, Part 2, Multicenter Feasibility Examine of Manualized MDMA-Assisted Therapy with an Optional fMRI Sub-Examine Assessing Adjustments in Brain Exercise in Subjects with Posttraumatic Stress Disorder Timeline

Completed Research

Part 3 Program of MDMA-Assisted Therapy for the Therapy of Severe PTSD - Part three Program Timeline MDMA + Cognitive-Behavioral Conjoint Therapy Examine (Charleston, South Carolina) - Conjoint Therapy Research Timeline Israeli Examine (Beer Yaakov, Israel) - Israeli Study Timeline U.S. Boulder Study (Boulder, Colorado) - U.S. Boulder Examine Timeline U.S. Veterans Examine (Charleston, South Carolina) - U.S. Veterans Study Timeline Canadian Study (Vancouver, BC) - Canadian Research Timeline U.S. Proof of Precept Study (Charleston, South Carolina) - U.S. Proof of Principle Examine Timeline Swiss Research (Soluthurn, Switzerland) - Swiss Examine Timeline Relapse Research (Charleston, South Carolina) - Relapse Research Timeline

Studies Under Growth

Open-Label, Multi-Site Research Research of the Security and Psychological Results of Manualized MDMA-Assisted Therapy in Wholesome Volunteer Therapists (MT2) - Open-Label, Multi-Site Research Examine of the Security and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists Timeline (MT2) Timeline A Part 2, Open-Label, Randomized Comparative Effectiveness Examine for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD Timeline - A Section 2, Open-Label, Randomized Comparative Effectiveness Examine for MDMA-Assisted Therapy in U.S.