U.S. Veterans Study: Treatment of First Subjects Begins

On January 7 and January 9, 2011, the first experimental sessions took place in our new study of MDMA-assisted psychotherapy for US veterans with chronic, treatment-resistant PTSD. Both patients underwent the first of three sessions with co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. These patients have also each received three preparatory non-MDMA psychotherapy sessions. The full study will eventually evaluate the safety and effectiveness of MDMA-assisted psychotherapy in 16 veterans with PTSD, and we are still in the process of recruiting additional subjects. As of January 19, 12 additional subjects have passed prescreening and are waiting on in-person medical and psychological screening. If you or someone you know might be eligible for the study and lives in the area of Charleston, SC, please contact berra@maps.org.

Two independent raters will simultaneously screen each of the first five subjects to assess baseline PTSD symptoms. In this process, both raters will score the same test (the Clinician- Administered PTSD Scale, or CAPS) to evaluate baseline PTSD symptoms. By using multiple independent raters, we can make sure that we are getting accurate and reliable information about the severity of each patient’s PTSD as well as train new raters. For both of the first two subjects, the raters have achieved an extremely high level of agreement, with ratings falling within three points of each other on a 136-point scale. This is also the first time we have used our internally generated web-based randomization software, which randomly assigns subjects to one of the three experimental conditions (pertaining to different dosages of MDMA). We are pioneering this randomization method because it is an extremely reliable and efficient way to randomly assign subjects to different conditions, which ensures the scientific validity of our results by increasing the effectiveness of the blind.

This new study builds on our recently completed study of MDMA-assisted psychotherapy (published July 2010 in the Journal of Psychopharmacology) in several ways. First, by separating the subjects into three groups (each group receiving different doses of MDMA) rather than two (each group receiving either a full dose of MDMA or an inactive placebo), we hope to get more detailed information about the role of MDMA in determining treatment effectiveness. Second, we hope to show that we can maintain an effective blind in these studies and affirm the scientific validity of clinical trials of psychedelic psychotherapy. Finally, since our previous study primarily involved female survivors of sexual abuse and assault, we hope this study will show that the benefits of MDMA-assisted psychotherapy extend to the population of veterans with war-related PTSD.