Certain qualifying therapists can now volunteer to be administered the psychedelic MDMA in order to gain personal knowledge of the treatment—a process considered an important element in preparation and training to deliver psychedelics-assisted therapies to patients suffering from PTSD.
The U.S. Food and Drug Administration granted permission to the Multidisciplinary Association for Psychedelic Studies (MAPS), a research institution and key partner in clinical trials investigating the therapeutic effects of MDMA in PTSD patients. The Phase 1, open-label, multi-site research study will assess the safety and psychological effects of MDMA-assisted therapy in healthy volunteer therapists training to administer the same medicine to people suffering from PTSD. The study will measure the development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients.
“Allowing therapist trainees to enroll in [the study] will support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” says MAPS PBC Director and Head of Training and Supervision Shannon Carlin, M.A., L.M.F.T.
The approval comes after the FDA lifted a clinical hold it placed on the study 20 months ago due to concerns about the scientific merit of the study, risk-to-benefit ratio for healthy therapist participants, and the credentials of the clinical investigators. MAPS fought the appeal, eventually convincing the agency of the study’s merit.
“This is MAPS at its best, negotiating with the FDA in an evidence-based manner with existing and new data that we analyzed specifically for our response,” explains MAPS Executive Director Rick Doblin, Ph.D. “For three decades, we have sought to educate the FDA in our novel approach rather than simply accept FDA requirements that are unjustified by the evidence. The dedicated work and incisive strategy of our Clinical Development team continues to improve the regulatory landscape for all future patients of psychedelic-assisted medicines.”
MDMA-assisted therapy is currently under investigation for the treatment of PTSD, and other mental health conditions including eating disorders and social anxiety. Earlier this month results from a Phase 3 clinical trial published in the journal Nature, showed that two-thirds of PTSD patients who received MDMA-assisted therapy experienced so much improvement in symptoms two months after the therapy that they no longer met the criteria for PTSD. A second Phase 3 trial is currently underway and, provided the results are just as promising, could lead to FDA approval of MDMA.
