Summmary: Marijuana Moment chronicles MAPS’ recent success in gaining FDA authorization to proceed with a Phase 1 trial of MDMA-assisted therapy in healthy volunteer therapists after a 20-month clinical hold on the study.
“This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful,” explains MAPS Public Benefit Corporation (MAPS PBC) CEO Amy Emerson.
Originally appearing here.
The Food and Drug Administration (FDA) has already authorized clinical trials into the therapeutic potential of MDMA for patients with post-traumatic stress disorders—but now it’s given the green light to a psychedelics research institute to expand its studies by administering the substance to certain therapists.
Volunteer therapists who are being trained to treat people with PTSD will be able to participate in the Phase 1 trials to gain personal experience with the treatment option. This is a complementary research project that comes as the Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of conducting Phase 3 trials involving people with the disorder.
The development comes months after Canadian regulators announced that certain therapists would be allowed to take psilocybin in order to gain a better understanding of the psychedelic when treating patients.
MAPS sought permission to proceed with the therapist-specific trials in 2019, but FDA placed them on a 20-month hold because of concerns about the merits, risks and credentials of investigators. MAPS appealed that hold, providing evidence about the study’s scientific value and ability of its staff, and FDA cleared them on Tuesday.
The organization “chose to dispute” FDA’s hold not just because of the impact it had on the planned studies, “but in an attempt to resolve an ongoing issue with the FDA regarding investigator qualifications across studies,” it said in a press release on Wednesday.
“While the term ‘dispute’ may seem adversarial, this process can actually strengthen the relationship and trust between us and our review Division and ensures the Division has support on this project from the [FDA] Office of Neuroscience,” MAPS Public Benefit Corporation (PBC) CEO Amy Emerson said. “This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful.”
Now MAPS is able to launch the Phase 1 clinical trials into MDMA-assisted therapy for therapists.
It will be designed to “measure development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients,” the association said.
Getting personal experience with the substance “is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.”
This will “support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” and it “builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment,” MAPS PBC Director and Head of Training and Supervision Shannon Carlin said.
FDA first granted MAPS’s request for an emergency use authorization for MDMA in PTSD in 2017. The organization expects to complete its Phase 3 trails in 2022.
The scientific expansion move also comes as the psychedelics decriminalization movement continues to build in the U.S.