Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA
The FDA permitted us to proceed with our clinical investigation, “A Phase I Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA when Administered to Healthy Volunteers,” also referred to as our MDMA/PTSD therapist training protocol.
Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDAs goals and MAPS goals. Now that we have the FDAs “may proceed” letter, we will be seeking approval from an Institutional Review Board (IRB).
We will be measuring the psychological effects of MDMA on “healthy normals” as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS). As a crossover study, subjects will get placebo on one occasion and MDMA on the other.
The FDAs “may proceed letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams.