On June 14, 2016, the U.S. Drug Enforcement Administration (DEA) approved 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). Dr. Monson is a leading expert on individual and conjoint cognitive therapies to treat PTSD.
The study will enroll 10 dyads, each pair with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. This is the first MAPS-sponsored MDMA study to employ measures developed for the DSM-5. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists. The study has received approval from all necessary government agencies, and will begin screening local participants residing around South Carolina for enrollment this summer.
