Feds Greenlight New Clinical Study Enabling Therapists to Use MDMA Legally

The US Food and Drug Administration (FDA) has just approved a new clinical study that enables therapists to legally use MDMA.

This new study, conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), enables a select group of volunteer therapists to gain personal experience with the use of MDMA. For this Phase 1 study, MAPS will hire 150 therapists who are currently being trained to deliver MDMA-assisted therapy sessions for PTSD.

During the study, after taking 120 mg of MDMA, each participant received a psychotherapy session from a licensed therapist. Over the next two months, the researchers will assess whether the subjects experience increased self-compassion, professional burnout, or other changes in their professional quality of life.

This study not only assesses the occupational and health risks associated with using MDMA for therapists, but also provides these clinicians with valuable personal experiences to help them administer this therapy to others.

“Allow therapists’ trainees to enroll [this study] will support the goals of the MDMA therapy education program to provide comprehensive training to future providers, “said MAPS PBC Director and Head of Education and Monitoring, Shannon Carlin, MA, LMFT, in a statement. “This work strengthens the ability to provide quality, accessible care to patients until MDMA-assisted therapy is approved as a statutory prescription treatment.”

MAPS actually asked the FDA for permission to start the study as early as 2019, but the agency decided to put the study on clinical hold for 20 months. At the time, the government argued that it was too risky to allow therapists to use MDMA and that the researchers were insufficiently qualified to conduct the study safely.

Fortunately, MAPS has already conducted several clinical studies confirming that this treatment is both safe and effective. Just last week, the organization released the results of a groundbreaking Phase 3 clinical trial that found MDMA-assisted therapy to be 90 percent effective in treating PTSD. The compelling results of this study have proven beyond any doubt that the government’s concerns about the therapist study were unfounded, and the FDA cleared the clinical suspension last week.

Based on the strength of MAPS research, the FDA is working towards final approval of MDMA-assisted therapy as part of its Breakthrough Therapy program. If everything goes according to plan, this therapy will be legal by 2023, underscoring the need to train therapists to administer these treatments effectively.

“This is MAPS at its best, which is evidence-based negotiating with the FDA on existing and new data that we have analyzed specifically for our response,” said Dr. Rick Doblin, executive director of MAPS, in a statement. “For three decades we’ve tried to train the FDA on our novel approach, rather than simply accepting FDA requirements that the evidence doesn’t justify. The dedicated work and radical strategy of our clinical development team continue to improve the regulatory landscape for all future patients with psychedelic assisted drugs. ”

Last December, the Canadian government also agreed to allow a select group of therapists to legally use psilocybin to gain personal insights that will help them conduct psychedelic therapy sessions.