First Two Subjects in U.S. Veterans Study Scheduled for MDMA Session in January

The first two veterans in our newest MDMA-assisted psychotherapy study are now scheduled for their experimental sessions in January. Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., are leading this MAPS-sponsored study at their private office in Charleston, SC. In this study we are only enrolling veterans suffering from war-related PTSD who have tried other treatments and failed. In preparing the study, we found that veterans are different from survivors of sexual abuse and assault in that they are more likely to be taking opiate medications for pain. In the current protocol, we are using fixed dosages and cannot increase the dose of MDMA if the opiates blunt the effect. The team was concerned that opiates could cause MDMA to be less effective. When we learned that one of the potential subjects was prescribed opiate pain medication, our clinical team conferred with medical monitor Julie Holland, M.D., to create a policy for enrolling patients with chronic pain. We decided we would enroll subjects who are currently taking opiate medications for pain as long as they agreed to forego or reduce their medication on the day that they receive MDMA. We’ll use what we learn in this pilot study to decide whether, and under what conditions, it makes sense in future studies to continue to enroll subjects on opiate pain medications.