Therapist Training Protocol Submitted to FDA

We submitted to FDA a protocol that would allow therapist from our MDMA/PTSD research teams to take MDMA in a clinical-therapeutic setting. We believe that it will benefit therapist who will be working with patients undergoing difficult emotional therapy to have a subjective understanding of an MDMA experience. The only way such an experience can be legally obtained is through FDA approval of a protocol for that purpose.

There is a precedent for our current protocol from the 1970s. Dr. Stanislav Grofs team at Spring Grove Hospital had FDA permission to administer LSD to mental health professionals involved in LSD research. Over 100 medical professionals received LSD in those training sessions, including doctors, therapists, counselors, nurses and attendants. These LSD sessions helped the mental health workers apply a therapeutic approach to patients undergoing LSD psychotherapy and when consulting with patients who had had LSD experiences. We submitted letters from two participants of that program to FDA, including one from John Hopkins researcher William Richards, PhD.

Protocol: MDMA Administration in a Therapeutic Setting in People Who Have Completed the MAPS Training Program for Therapists Learning to Conduct MDMA-Assisted Therapy Research in Subjects with PTSD .