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Trial to Test Low-Dose Psilocybin for Mental Distress

Psilocybe aztecorum

Psilocybe aztecorum, also known as “magic mushrooms,” the source of psilocybin (Alan Rockefeller, Wikimedia Commons)

21 Mar. 2023. A developer of mental health therapies from psychedelic compounds says it received FDA clearance for a clinical trial testing low doses of psilocybin. The trial is being conducted and sponsored by Diamond Therapeutics Inc. in Toronto, Ontario, Canada with University of Alabama at Birmingham, the site of the study.

Diamond Therapeutics is a five year-old enterprise developing treatments for mental health disorders derived from chemical compounds such as psilocybin associated with psychedelic experiences. Psilocybin is a mind-altering compound found in some types of mushrooms and considered a controlled substance under U.S. drug laws, but since 2020 legalized in Oregon for certain prescription therapies. As a recreational drug, psilocybin is associated with feelings of euphoria and sensory distortion, and while not considered addictive, its users run risks of psychotic episodes such as hallucinations, panic, and anxiety.

Feelings of hopelessness and helplessness

In Dec. 2022, Diamond completed an early-stage trial testing the safety of low-dose psilocybin that the company says was regulated by Health Canada. Diamond says the study enrolled 56 participants who tested psilocybin at various doses to determine a safe low-dose quantity. The company says its findings show psilocybin is psychoactive, but participants still show no adverse effects at low doses that might preclude its use as an outpatient treatment. Diamond announced the findings on its web site, which are not yet peer-reviewed.

The new clinical trial, also an early-stage study, is enrolling 60 participants age 25 to 65 experiencing demoralization syndrome, a disorder marked by feelings of hopelessness and helplessness from loss of meaning or purpose in life. Clinical demoralization is found in some people with progressive or terminal diseases, such as cancer. The trial is directed by Peter Hendricks, professor of public health at University of Alabama at Birmingham, who studies medical cannabis and psychedelics as mental health treatments. Diamond says the U.S. Food and Drug Administration approved the company’s investigational new drug application that in effect authorizes a clinical trial.

Participants in the trial are randomly assigned low doses of psilocybin ranging from 1 to 5 milligrams, or a placebo, given once a week for five weeks. The study team led by Hendricks is looking primarily at changes in participants’ scores on a standard scale of demoralization over eight weeks, but also participants’ reports of mystical experiences, an indicator of hallucinogenic reactions, and challenging experiences, another name for “bad trips” — panic, confusion, or paranoia — during the five-week administration of low-dose psilocybin.

“This clinical trial will allow us to explore the therapeutic potential of low-dose psilocybin,” says Hendricks in a Diamond Therapeutics statement released through Cision. “We have only begun to understand how and when psilocybin might be beneficial to mental health, and I see this study as the first of many to come.”

“This trial is a key milestone,” notes Diamond’s founder and CEO Judith Blumstock, “in Diamond’s pursuit of low-dose, sub-perceptual, psychedelic-derived medicines that are safer and more effective for patients than the current first-line treatments.” The company says it also plans a mid-stage clinical trial in Canada testing low-dose psilocybin to treat generalized anxiety disorder, with therapies taken at home rather than a clinic.

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