番茄社区

One of the first studies to examine a psychedelic's effects on the mental health of healthcare workers has received a green light from the FDA and is set to start, according to sources and reports.

Anthony Back, MD, of the University of Washington (UW) in Seattle, is leading a randomized trial into how the compound psilocybin (often dubbed "magic mushrooms") combined with psychotherapy might help frontline healthcare workers handle pandemic-induced distress. The FDA recently issued an investigational new drug approval letter for the research team to start what Back called a first efficacy, proof-of-concept study.

"The current situation for healthcare workers is pretty serious, and it's not clear that we have a documented therapy that really works," said Back, who co-directs UW's Center for Excellence in Palliative Care and studies communication within healthcare. "So I think it's important for us to be evaluating and assessing new treatments."

Back's team plans to administer 25 mg doses of synthesized psilocybin and host an initial therapy session, followed by three follow-up therapy sessions. The 30 participants will be evenly split into psilocybin and placebo groups, but all will get counseling. The researchers will measure levels of depression, anxiety, and burnout, among other outcomes.

Back's team is working with the Canadian biopharmaceutical company , planning to apply an adapted version of Cybin's new psychedelic-assisted therapy program to train and guide therapists. Approximately six to eight licensed clinicians across disciplines at UW and elsewhere are being trained to co-lead the sessions with individual participants, Back said.

Cybin also is co-funding the study; the chief funder is the .

Participants will be eligible if they have at least moderate depression, Back said, with enrollment screening set to start next week.

Researchers are striving for a diverse participant and clinician pool. That has been rare in modern psychedelics research, sources have told 番茄社区. "This [EMBARK] version includes material that specifically addresses cultural inclusion anticipating a diverse population of clinicians," according to.

Ladybird Morgan, RN, MSW, a hospice and palliative care specialist who helped author the EMBARK framework, told 番茄社区 that she pushed for the diversified approach.

"Medicine is such a world of self-sacrificing ... [without] understanding what the impact is on the culture at large," Morgan said. "I hope people in medicine realize everything is connected, how I take care of myself will affect how I take care of other people."

Back does not expect study results to be available for about a year, he said. The researchers settled on 25 mg of psilocybin because that dose has been validated in previous studies, he said. The nonprofit is supplying the psilocybin.

Cybin plans to apply this study to a future trial of a psilocybin derivative it is developing, according to the release. Back said the company plans to model the current study's design and clinician training.

"I am optimistic" that psilocybin could help frayed healthcare workers, including those whose mental health has been harmed by the pandemic, Back said. Previous studies have shown psilocybin acts in a different manner than selective serotonin reuptake inhibitors against depression, he noted, for example.

Back's study is believed to be the first in the U.S. to examine psychedelics and healthcare workers. Researchers with Vancouver Island University in Canada from a quality improvement trial of providers suffering from post-traumatic stress disorder and treatment-resistant mental health problems earlier this year.

These studies join the numerous examinations of psychedelics' mental health properties underway at several standalone academic psychedelics research centers that have launched over the last 2 years.

Cybin launched EMBARK in October, according to the release. The company did not return requests for comment early this week.

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