Summer 2009 Vol. 19, No. 2 Research Edition
MAPS is preparing a follow-up study to our US pilot study of MDMA-assisted psychotherapy for the treatment of PTSD, conducted under the direction of MAPS-sponsored researchers Michael Mithoefer, MD, and Ann Mithoefer, BSN. This new study will enroll eight US veterans with PTSD from the wars in Iraq or Afghanistan.
There are three purposes for conducting this study. The first purpose is to see if veterans respond any differently than those who suffer PTSD from sexual assault, sexual abuse, or victims of crime. Veterans made up a small minority of subjects in the Mithoefers’ previous study (out of 21 subjects, only two were veterans). The EMEA has published guidelines for PTSD research that call for studies with homogenous subpopulations of people who suffer from PTSD from different causes. This is to determine if the same therapy can be administered across these subpopulations. It is possible that people with PTSD from different causes will require different therapeutic protocols for MDMA–assisted psychotherapy, or that some subpopulations could be unresponsive to MDMA-assisted psychotherapy. If people with PTSD from different causes are found to respond well to similarly designed protocols, then we can include all of these subpopulations in the larger Phase 3 multi-site studies. If we find that the treatments are different, we will have to take this into consideration when designing the Phase 3 studies.
The second purpose of this new study in veterans will be to gather methodological information about how different doses of MDMA succeed in creating an effective double-blind study. The researchers and subjects in our pilot study were often able to accurately guess when asked whether subjects had received an active dose of MDMA or an inactive placebo. The new study of veterans involves administering doses of 125 mg, 75 mg, or 25 mg (with four of the subjects randomized to receive 125 mg, two to 75 mg and two to 25 mg). We will see if the use of these three doses can be a successful double-blind study. We will also look to see if people who receive the higher doses showed a larger therapeutic effect than people who receive the lower doses.
The third and final purpose of the study is to enroll some subjects previously excluded for risk factors such as hepatitis C and hypertension. There is not strong evidence that MDMA poses greater risks to people with these health conditions, but we excluded these factors from our first pilot study in order to proceed cautiously and please our Institutional Review Board (IRB). The new protocol will involve special pre and post-screening and monitoring plans to evaluate whether MDMA can be safely administered to people with previously excluded risk factors. If we can safely enroll these subjects, then recruitment into our Phase 3 studies will be faster since fewer subjects will be excluded for risk factors.
This protocol will be submitted to the FDA in September. After it is submitted and approved by the FDA, it will be submitted to our IRB. We hope to have the first subject enrolled before the end of November 2009.
On March 4, 2009, MAPS’ MDMA/PTSD research was featured on military.com, a popular military website (read the full text of this article on the MAPS website: www.maps.org/media). Since then, numerous war veterans who wish to be in the study have contacted us. However, it is not clear whether all of them will pass the screening process and some may no longer be interested in participating by the time the study gets started. If you know, or are yourself, a war veteran suffering from PTSD who would be interested in participating in a study in Charleston, South Carolina, please contact MAPS at: email@example.com.