Michael Mithoefer, M.D.

It’s exciting that other studies of MDMA-assisted psychotherapy will soon be starting at Harvard and, most likely, in Israel, Switzerland and Germany.

MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD): Sixth Update on Study Progress

By Michael Mithoefer, M.D.

We’re approximately at the halfway point of the study of the MAPS-sponsored study using MDMA-assisted psychotherapy in the treatment of Posttraumatic Stress Disorder in Charleston, South Carolina. Currently the numbers are as follows:

• We have done telephone screening on seventy-eight potential subjects. If they pass phone screening they are then eligible to come for full screening in person.
• Thirteen people have come for full screening which involves meeting with us to sign the informed consent, meeting with the psychologist for measurement of PTSD symptom levels and screening for other psychiatric diagnoses, and undergoing medical screening (physical exam, EKG and laboratory tests).
• Eleven subjects have been enrolled in the study. About two thirds have been from South Carolina or North Carolina. The rest have come from as far away as Hawaii.
• The eleventh subject completed the full screening in late August and will soon begin the rest of the protocol.
• Nine subjects have completed the double blind protocol.
• One subject withdrew before having the second experimental session. The reason for withdrawal did not appear to be related to the experimental session. In keeping with our intention to collect as much data as possible about anyone who does not complete the protocol, she has agreed to return for repeat outcome measures.
• Two of the subjects who received placebo in the double blind stage have returned for two open-label MDMA sessions along with nine additional non-drug psychotherapy sessions and additional outcome measures.
• Three potential subjects are currently scheduled to come for screening visits. This is providing useful additional data as these subjects serve as their own controls.

At times recruiting has been slower than we would like, but we’re pleased with the steady progress of the study, and our results continue to be very encouraging. It’s exciting that other studies of MDMA-assisted psychotherapy will soon be starting at Harvard and, most likely, in Israel, Switzerland and Germany. It will be extremely useful to compare data from similar studies in different locations. The ongoing support for protocol development and psychedelic research provided by MAPS members, donors and staff is making this possible.