The US Food and Drug Administration (FDA) has just approved a new clinical trial that will allow therapists to legally use MDMA.
This new study, conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), will allow a select group of volunteer therapists to personally gain experience with using MDMA. For this Phase 1 trial, MAPS will recruit 150 therapists that are currently being trained to conduct MDMA-assisted therapy sessions for PTSD.
During the study, each participant will receive one session of psychotherapy from a licensed therapist after taking 120mg of MDMA. Over the next two months, researchers will evaluate whether the subjects experience increased self-compassion, professional burnout, or any other changes to their professional quality of life.
In addition to assessing the professional and health risks of allowing therapists to use MDMA, this trial will grant these clinicians valuable personal experience that will help them administer this therapy to others.
“Allowing therapist trainees to enroll in [this study] will support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” said MAPS PBC Director and Head of Training and Supervision Shannon Carlin, MA, LMFT in a statement. “This work builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment.”
MAPS actually asked the FDA for permission to begin the trial back in 2019, but the agency chose to put the trial on a 20-month clinical hold. At the time, the feds argued that allowing therapists to use MDMA was too risky, and that the researchers did not have enough qualifications 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 published the results of a groundbreaking Phase 3 clinical trial demonstrating that MDMA-assisted therapy is 90 percent effective at treating PTSD. The powerful findings of this study proved beyond reasonable doubt that the feds' concerns over the therapist study were unfounded, and the FDA released the clinical hold last week.
Based on the strength of MAPS' research, the FDA is working towards granting final approval to MDMA-assisted therapy under its “Breakthrough Therapy” program. If all goes to plan, this therapy will be legal by 2023, which underscores the need to train therapists to effectively administer these treatments.
“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,” said MAPS Executive Director Rick Doblin, PhD, in a statement. “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.”
Last December, the Canadian government also agreed to allow a select group of therapists to legally use psilocybin in order to gain personal insights that will help them conduct psychedelic-assisted therapy sessions.