FDA Grants Authorization Allowing Research Institute to Study Psychedelic Use by Therapists
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The Multidisciplinary Association for Psychedelic Studies (MAPS) was recently granted authorization to administer MDMA to therapists. This comes after the FDA, which gave its approval, also allowed institutes to conduct clinical trials on MDMA and its therapeutic potential in treating PTSD.
The therapists, who have all volunteered, are currently undergoing training on how to treat individuals suffering from post-traumatic stress disorder and will be allowed to take part in phase 1 trials in an attempt to acquire personal experience from this treatment option. This complementary research project will be conducted by MAPS, which is also conducting phase 3 clinical trials on individuals suffering from PTSD.
This development comes after regulators in Canada revealed that therapists would be permitted to consume psilocybin in an attempt to better understand the substance, which may be administered as a treatment to patients.
The psychedelics research institute had first sought authorization in 2019. However, the Food and Drug Administration placed the request on hold for more than a year as there were concerns about the credentials, risks and merits of the investigation. To appeal the hold, the research institute provided evidence about the scientific value of the study.
Last week, the organization revealed in a press release that it had disputed the hold because of the effect it had on the planned research, adding that it also aimed to settle an issue concerning researcher qualifications across studies with the agency.
Amy Emerson, CEO of the MAPS Public Benefit Corporation, noted that the process would help strengthen the trust and relationship between the institute and the review division, while also making sure that the division received support from the agency’s office of neuroscience.
MAPS may soon commence phase 1 clinical trials on psychedelic-assisted therapy for therapists, with a focus on MDMA. The association revealed that the trial would measure professional burnout, quality of life and development of self-compassion in therapists administering the psychedelic treatment to patients.
Shannon Carlin, director and head of training at MAPS PBC, noted that it would also help support the institute’s MDMA therapy training program objectives, the primary one being to offer comprehensive training to future practitioners. This, she said, was in addition to building the capacity to deliver accessible and quality care to patients, even before MDMA-assisted therapy was approved as a legal prescription treatment.
Earlier in 2017, the Food and Drug Administration granted MAPS emergency use authorization for MDMA in the treatment of post-traumatic stress disorder. The research institute plans to conclude its phase 3 trials in 2022.
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