MDMA-Assisted Therapy Study Protocols
Phase 3 Trials: FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment
MAPS' highest priority project is sponsoring Food and Drug Administration (FDA) drug development research into 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of posttraumatic stress disorder (PTSD). FDA has designated MDMA-assisted therapy for PTSD a Breakthrough Therapy, and has come to agreement with MAPS on Phase 3 protocol designs after a rigorous Special Protocol Assessment (SPA) process. MAPS' goal is to develop MDMA-assisted therapy for PTSD into an FDA-approved prescription treatment. The Phase 3 trials are expected to be complete in 2022, meaning that FDA could approve the treatment as soon as 2023. MAPS is also initiating Phase 2 trials in Europe.
We are studying whether MDMA-assisted therapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas. We also sponsored completed studies of MDMA-assisted therapy for autistic adults with social anxiety, and MDMA-assisted therapy for anxiety related to life-threatening illnesses.
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 access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked, and who are unable to participate in Phase 3 clinical trials. The program will enroll 50 PTSD patients at up to 10 sites in the U.S. Site locations will be announced in the next few months.
Expanded access is a U.S. FDA program that allows the use of an investigational drug under a Treatment Protocol. The program is designed to address urgent and life-threatening conditions in patients who do not currently have promising treatment options. Only sites within the U.S. and U.S. territories are eligible to participate in the U.S. FDA's expanded access program. You can learn more about expanded access on the FDA’s website.
New sites meeting the requirements listed below may seek approval to participate in MAPS PBC’s multi-center expanded access protocol under an FDA Treatment IND, which would allow them to administer open-label MDMA-assisted therapy for PTSD in line with the single approved protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted therapy per Schedule I regulations with approval by regulatory agencies and under supervision of MAPS PBC.
We have a online training application for eligible expanded access sites and providers.
Learn about our MDMA Therapy Training Program.
MAPS is undertaking a plan to make MDMA-assisted therapy into a Food and Drug Administration (FDA)-approved prescription treatment by 2023. For-profit pharmaceutical companies are not interested in developing MDMA into a medicine because the patent for MDMA has expired. The idea of using MDMA to assist therapy of any kind for any specific clinical indication has long been in the public domain.
In MDMA-assisted therapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for years, and sometimes forever.
MDMA is not the same as "Ecstasy" or "molly." Substances sold on the street under these names may contain MDMA, but frequently also contain unknown and/or dangerous adulterants. In laboratory studies, pure MDMA has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses.
Explore MAPS in the Media for the latest 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
- Expanded Access Program: MDMA-Assisted Therapy for PTSD
- Expanded Access Program Timeline
- Open-Label Lead-In Study of MDMA-Assisted Therapy for PTSD (United States and Canada)
- Open-Label Lead-In Study Timeline
- Phase 3 Program of MDMA-Assisted Therapy for the Treatment of Severe PTSD (MAPP2)
- Phase 3 Program Timeline
- U.S. Therapist Training Study (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 Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder (United Kingdom, Germany, Portugal, Norway, the Czech Republic, and the Netherlands)
- An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Therapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder Timeline
- Phase 3 Program of MDMA-Assisted Therapy for the Treatment of Severe PTSD
- Phase 3 Program Timeline
- MDMA + Cognitive-Behavioral Conjoint Therapy Study (Charleston, South Carolina)
- Conjoint Therapy Study Timeline
- MDMA and Startle Testing Study (Atlanta, Georgia)
- Startle Testing Study Timeline
- Israeli Study (Beer Yaakov, Israel)
- Israeli Study Timeline
- U.S. Boulder Study (Boulder, Colorado)
- U.S. Boulder Study Timeline
- U.S. Veterans Study (Charleston, South Carolina)
- U.S. Veterans Study Timeline
- Canadian Study (Vancouver, BC)
- Canadian Study Timeline
- U.S. Proof of Principle Study (Charleston, South Carolina)
- U.S. Proof of Principle Study Timeline
- Swiss Study (Soluthurn, Switzerland)
- Swiss Study Timeline
- Relapse Study (Charleston, South Carolina)
- Relapse Study Timeline
Studies Under Development
- Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (MT2)
- Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists Timeline (MT2) Timeline
- A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD Timeline
- A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Therapy in U.S. Military Veterans with Chronic PTSD Timeline Timeline
MDMA-Assisted Therapy for Eating Disorders
Studies Under Development
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
More MDMA Resources
MAPS-Sponsored MDMA Projects: Investigator's Brochure, Treatment Manual, Annual Report
- A Manual for Adherence Ratings of MDMA-Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder
- MDMA Investigator's Brochure and FDA Annual Report
- Treatment Manual: MDMA-Assisted Psychotherapy for PTSD
- MDMA Literature Review/Investigator's Brochure
- Participant Safety in Psychedelic Therapy
Resources from MAPS
Resources from Other Sites
MDMA Scientific Literature, Government Hearings, and Archive
Our archive includes articles about about the history of MDMA in science and politics.