On October 16, 2012, MAPS Executive Director Rick Doblin, Ph.D., and the MAPS clinical team met via teleconference with a member of the grants administration staff at the National Institute of Mental Health (NIMH) in Washington, D.C. Earlier in October, Rick Doblin contacted NIMH Director Thomas Insel about whether NIMH would be willing to review a grant application from MAPS for research into MDMA-assisted psychotherapy for PTSD. Dr. Insel responded immediately and encouraged us to apply. The MAPS clinical team will continue working with NIMH staff to develop a grant proposal with the greatest chance of success. The proposal would be due in either February or June 2013. Due to the need to prioritize our limited resources, and because the FDA only requires proof of safety and efficacy to approve a treatment, MAPS has focused on developing studies that show safety and effectiveness rather than explaining how MDMA-assisted psychotherapy works. NIMH is interested in studies that investigate mechanisms of action as well as therapeutic outcomes. If federal funds were to be awarded for MDMA-assisted psychotherapy for PTSD research, we’d start gathering data about both mechanism of action and therapeutic outcomes. We are currently exploring whether to apply for the February or June 2013 deadline, after which the review process would take about a year. Obtaining grants for innovative treatments is challenging, so it’s not possible to predict the chances of success. Still, to be able to submit a grant application to NIMH with guidance from NIMH staff is a remarkable development. As far as we know, the last time NIMH funded psychedelic psychotherapy research was over 40 years ago. NIMH has recently funded research into the use of ketamine in the treatment of refractory depression; however, in this case the ketamine was not used as an adjunct to psychotherapy but rather as an independent pharmacological treatment. Should MAPS succeed in obtaining NIMH funding for a Phase 2 study of MDMA-assisted psychotherapy for PTSD, it’s possible that NIMH might be open to a larger grant supporting Phase 3 studies. “For NIMH, multi-year grants of several millions of dollars are not unusual,” said MAPS Executive Director Rick Doblin, Ph.D. “We can always dream!”
