Conjoint Therapy: FDA Accepts New Study Protocol

On January 26, 2016, the U.S. Food and Drug Administration (FDA) accepted the protocol for our upcoming study of MDMA-assisted psychotherapy for PTSD in couples. Led by Principal Investigator Michael Mithoefer, M.D., and Sub-Investigator Candice Monson, Ph.D., this will be a pilot Phase 1/Phase 2 open-label study exploring Cognitive-Behavioral Conjoint Therapy (CBCT) integrated with MDMA-assisted psychotherapy for the treatment of chronic posttraumatic stress disorder (PTSD). Candice Monson, a developer of CBCT, was introduced to MAPS by the U.S Department of Veterans Affairs National Center for PTSD.

The study will enroll 10 pairs of participants, each with one participant diagnosed with PTSD, and one concerned significant other who does not have PTSD. There are several important reasons to include significant others in PTSD treatment, in addition to the data supporting the efficacy of CBCT for PTSD. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists.