Developing MDMA (3,4-methylenedioxymethamphetamine) into an FDA-approved prescription medicine for PTSD is our top funding priority. We are currently conducting or developing clinical trials of MDMA-assisted psychotherapy in the United States, Canada, Israel, and Switzerland.
MDMA is known for its unique ability to give users a gentle yet profound feeling of self-acceptance, thus allowing them to confront difficult traumas and emotions in the context of psychotherapy. To learn more about why MDMA-assisted psychotherapy holds such promise for PTSD patients, please see our prospectus or visit www.mdmaptsd.org.
A large body of research is already available on the physiological and psychological risks of MDMA, enabling MAPS to move forward with clinical studies of its safety and effectiveness in specific patient groups. MAPS is currently conducting numerous “Phase 2” pilot studies of MDMA-assisted psychotherapy for PTSD, in which we evaluate the effectiveness of the treatment and add to existing safety data in relatively small numbers of subjects.
We are preparing to move to “Phase 3” of our drug development program, involving scores of therapists and hundreds of subjects in multiple countries. The challenge is no longer convincing regulatory agencies of the value of this research, but finding the financial resources for conducting the Phase 3 studies required to make MDMA-assisted psychotherapy a legally available treatment for those who need it most. Learn more about the U.S. Food and Drug Administration’s guidelines for drug development.
Our results have been promising: A full 83% of the subjects receiving MDMA-assisted psychotherapy in our flagship US Phase 2 study no longer met the criteria for PTSD, and every patient who received a placebo and then went on to receive MDMA-assisted psychotherapy experienced significant and lasting improvements. These results were published in July 2010 in the Journal of Psychopharmacology.
We are now conducting a new Phase 2 study of MDMA-assisted psychotherapy for PTSD in US veterans of war, which will expand on these results and help improve our treatment methodology. These improvements include developing our therapeutic model, training therapists to conduct Phase 2 and 3 studies, determining whether different causes of PTSD require different treatment methods, establishing an effective double-blind for our studies, discovering the size and variability of treatment effects, and determining how cultural differences affect treatment outcomes. Finding the funds to complete our current Phase 2 study in veterans is therefore of critical importance, not just for the patients involved but also for the future of psychedelic research worldwide.
Prominent media routinely feature our MDMA-assisted psychotherapy research program, including O: The Oprah Magazine, CNN, The Washington Post Magazine, The New York Times, The Boston Globe, and many more.
Donations to the MDMA-assisted psychotherapy research fund will help to:
- Complete our study of MDMA-assisted psychotherapy for PTSD in U.S. war veterans
- Complete an “intern study” comparing the effectiveness of different forms of MDMA-assisted psychotherapy for PTSD
- Analyze and publish the results of our long-term follow-up to our U.S. study of MDMA-assisted psychotherapy for PTSD
- Analyze and publish the results of our study of MDMA-assisted psychotherapy for PTSD in Switzerland
- Complete our study of MDMA-assisted psychotherapy for PTSD in Israel
- Initiate a study of MDMA-assisted psychotherapy for PTSD in Jordan
- Initiate a study of MDMA-assisted psychotherapy for PTSD in Canada
- Train therapists in our ongoing training protocol for MDMA psychotherapists
- Host a training retreat for MDMA-assisted psychotherapy researchers
- Revise our treatment manual for MDMA-assisted psychotherapy for PTSD
- Develop a training program for therapists interested in practicing MDMA-assisted psychotherapy
- Plan additional Phase 2 pilot studies of MDMA-assisted psychotherapy for PTSD in England and Australia
We estimate that it will take $2 million and three years to be ready for our End-of-Phase 2 meeting with the FDA, and an additional $13 million and seven years to complete Phase 3 and establish MDMA-assisted psychotherapy as a legally available treatment for PTSD. Our current funding needs for Phase 2 clinical trials are:
MDMA-assisted psychotherapy for PTSD in Veterans of War (South Carolina)
$1,401,000 estimated study cost / $610,000 still needed
MDMA-assisted psychotherapy for PTSD intern study (Colorado)
$481,000 estimated study cost / $291,000 still needed
MDMA-assisted psychotherapy for PTSD (Australia)
$50,000 needed / additional funds provided by co-sponsor
MDMA-assisted psychotherapy for PTSD (Switzerland)
MDMA-assisted psychotherapy for PTSD (Canada)
$584,000 estimated study cost / $568,000 still needed
MDMA-assisted psychotherapy for PTSD (Israel)
$468,000 estimated study cost / $428,00 still needed
MDMA-Assisted Therapy Research Fund