Category: MDMA-Assisted Psychotherapy for PTSD: MAPS-Sponsored Clinical Trials

A Phase 1/2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in which One Member Has Chronic Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Michael Mithoefer, M.D.

Sub-Investigator: Candice Monson, Ph.D.

Medical Monitor: Julie Holland, M.D.

Location: Charleston, SC (USA)

This is 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). This study enrolled 6 dyads (pairs) consisting of one participant diagnosed with PTSD, and one concerned significant other who does not have a current PTSD diagnosis but who is experiencing problems associated with the psychosocial circumstances related to the PTSD participant's diagnosis. The primary outcome measure is the Clinician-Administered PTSD Scale according to DSM-5 (CAPS-5) administered to the participant with PTSD. Additional measures evaluate the qualities of the relationship between the participants, and psychological distress in the significant other.

MDMA may hold promise in catalyzing the effects of CBCT for PTSD. Given the properties of MDMA, specifically in inducing empathy and interpersonal openness, these psychopharmacological effects are especially relevant to the purported mechanisms of CBCT for PTSD.

There are several important reasons to include significant others in PTSD treatment, and to treat them as clients versus “support persons,” in addition to the data supporting the efficacy of CBCT for PTSD. MDMA is expected to facilitate this communication and connection, given MDMA’s purported mechanisms of action. For these reasons, CBCT for PTSD was developed to be a true interpersonal treatment for PTSD, which is why MDMA will be administered to both participants.

This study combined methods described in the Treatment Manual for MDMA-Assisted Psychotherapy with methods from the CBCT for PTSD manual. The Treatment Manual for MDMA assisted-psychotherapy is not intended to define all interactions that occur in the therapy, instead providing a structure within which the therapy is expected to occur. This allows individual therapist teams to include therapeutic interventions based on their own training, experience, intuition, and clinical judgment, provided the interventions are compatible with the method and appropriate to the participant’s experience. The therapists carefully worked with both participants to establish a sense of safety, trust, and openness to create an environment supportive of healing.

Download the protocol for this study.

View the timeline for this study.

Read Breaking the Mold: Reflecting on Our Experiences in Same-Gender Therapist Teams with MDMA-Assisted Psychotherapy, written by Anne Wagner, Ph.D., C.Psych., Annie Mithoefer, BSN and Candice Monson, Ph.D., C.Psych.