A Randomized, Double-Blind, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
As we geared up for Phase 3 studies, finding a cost-effective and sustainable way to recruit effective therapists became a top priority. In this pilot study, we investigated the effectiveness of MDMA-assisted therapy for PTSD when one member of the standard co-therapist team was a healthcare intern (being trained in therapy, social work, or nursing). The other member of each team was a professional therapist trained in our treatment method. As interns work at a lower cost than fully-licensed therapists, this approach is theorized to reduce costs and train the next generation of psychedelic therapists.
“12 months after the third active-dose Experimental Session, 76% of participants no longer had PTSD.”
Participants in this study were U.S. veterans with PTSD, mostly from Iraq, Afghanistan, or Vietnam, along with survivors of childhood sexual abuse, assault, rape, as well as other types of trauma. This double-blind, placebo-controlled, Phase 2 pilot study in 28 participants found that one month after their second Experimental Session of MDMA-assisted therapy, 42.9% of participants in the active-dose (100 mg and 125 mg) MDMA groups did not qualify for a diagnosis of PTSD, compared to 33.3% of participants in the low-dose MDMA (40 mg active placebo) control group. 12 months after the third active-dose Experimental Session, 76% of participants no longer had PTSD.