Grant Application Page

Grant Application for Treatment Manual Development

Introduction

MAPS has long desired to submit a grant to the National Institute of Mental Health (NIMH) to support one of its studies. Obtaining a grant would be a great help in funding any one of our studies, and completing a grant application for a human clinical trial with MDMA or psychedelics would make the grant the first of its kind. It could no longer be said, as has Alan Leshner, former head of the National Institute on Drug Abuse (NIDA) that no one had ever written a grant to NIH for medical research with MDMA. Writing and submitting a grant also provided us all with greater experience on the process that might serve us well later.

We were advised by a consultant who has conducted research on psychotherapy for PTSD, we sought to obtain an RO3 or "Small research grant" rather than the usual "standard" grant. This kind of grant can be requested by a "new" researcher (an individual conducting research for the first time or who has not received a grant before). We chose to respond to a particular "announcement" in reference to developing novel methods or interventions. In this case, the aim of our proposal is to develop a working treatment manual for MDMA-assisted psychotherapy in people with PTSD suitable for training other therapists working in subsequent research studies. The grant requests support for a program including writing the treatment manual, producing evaluative guidelines and developing measures of therapist adherence and competence. This program will involve examination of recordings from psychotherapy sessions and input from chief treatment manual author June May Ruse and study PI Michael Mithoefer. Once developed, we can begin developing a training program for therapists interested in conducting studies of MDMA-assisted therapy, and this, in turn, should allow for the development of an innovative treatment.

The grant application was prepared in over two months, and involved at least one conference call between all participants. The grant application was prepared by MDMA/PTSD principal investigator Michael Mithoefer MD, with help from all other MDMA/PTSD treatment manual team members (June May Ruse PsyD, Ilsa Jerome PhD and Rick Doblin PhD) and with additional and much appreciated editorial help from Elizabeth Gibson MS. The consultant offered her expertise and answered questions concerning content, presentation, and the trivia and unwritten rules of completing grant forms. Finally, the grant was completed a day before the June 1 deadline and sent off by Dr. Mithoefer. On July 1, 2005, we received a notice from NIMH that they received the grant. Upon receipt, grants are either rejected without comment or scored on the basis of criteria such as significance, innovation, the unique qualifications of the investigators and the proposed setting for hte projects, with half the grants receiving a score and a critique. To be funded, grants must receive scores in the upper 15% or so. On November 5, 2005, Dr. Mithoefer received the disappointing news that NIMH had rejected the grant application. The NIMH prepared a summary statement containing reviewers' comments and critiques. After considering these comments and consulting with knowledgeable others, we decided to revise and resubmit the grant application upon completion of the study, and if the pilot data we obtain from the study is promising.

The Application

Here is the grant application in full and including the research plan in PDF and HTML format. Some segments of the grant have been edited to remove personal information and specific preliminary data.

Full Application (PDF format)
Research plan (PDF format)
Research plan (HTML)
Grant application rejection (PDF format)

News and Progress Reports

November 8, 2005. Dr. Michael Mithoefer received the disappointing news that the National Institute of Mental Health (NIMH) has rejected our grant application seeking $125,000 over two years for the development of a treatment manual for the use of MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD). MAPS' grant application was not scored (it was considered in the bottom half of all applications). This rejection isn't really surprising since the last time NIMH gave a grant for anything to do with psychedelic psychotherapy was over 30 years ago, with all NIMH intramural psychedelic psychotherapy research stopping in 1967. MAPS invested $2,768 in the NIMH grant application, but the money is not wasted. We have gained a better understanding of what it will take to complete the treatment manual that we have already begun to develop and we now can say that we have indeed tried to obtain funding from NIMH. Maybe once we complete the initial pilot study, we can submit the results to NIMH and try again to obtain support. It has been reported that in 2004, the Veterans Affairs Department (VA) spent $4.3 billion on PTSD disability payments! In 2006, the VA requested $2.2 billion for mental health services. Once we have completed our initial pilot study, we may have a better chance of obtaining some federal funding for MDMA/PTSD research.

May 31, 2005. Michael Mithoefer printed out and sent the grant application to NIMH.

May 4, 2005. The treatment manual research team engages in a conference call with MAPS research associate Lisa Jerome and MAPS president Rick Doblin presiding over the call.The discussion included study PI Michael Mithoefer MD, treatment manual first author June May Ruse PsyD, MAPS research associate and MDMA expert Lisa Jerome and the grant writing consultant. We reached many a valuable decision during this telephone conversation and the discussion shaped the development of our grant application.