Diamond Therapeutics Inc., a biotech company in the psychedelics sector has received authorization from Health Canada to launch a clinical trial to study the effects of low doses of psilocybin in healthy volunteers.
The trials mark the launch of Diamond’s clinical program which is aimed at analyzing the benefits of sub-perceptual, non-hallucinogenic treatments with psychedelics.
What Is Microdosing?
Microdosing is the practice of taking low, non-hallucinogenic doses of psychedelic molecules with the goal of receiving health benefits and other advantages such as mood enhancement or improved concentration.
While the practice received substantial press after it became public that several Silicon Valley executives and entrepreneurs engaged in microdosing, preliminary research conducted by the Imperial College of London raised doubts about its touted efficacy.
A placebo-controlled trial involving 191 participants found that the benefits reported by those who microdosed, or consumed tiny amounts of LSD, were equal to those found in the cohort consuming a placebo.
Still, a great deal of hope has been placed on anecdotal evidence showing the benefits of microdosing, as its commercialization could allow for a greater opportunity of revenue than high doses. Selling microdosing products could offer companies a window to sell psychedelic drugs continuously, providing a better market opportunity than the isolated high doses used in psychedelics-assisted psychotherapy.
Diamond’s Phase 1 Trial
Diamond’s trial will study the safety and pharmacokinetics of low doses of psilocybin in as many as 80 participants in a Phase 1, randomized, placebo-controlled, double-blind trial.
The company is basing its hypothesis on previously conducted animal studies, which showed that low, non-hallucinogenic doses of psilocybin could hold potential for therapeutic use. Diamond stated that these findings may help unlock the use of low-dose psilocybin to treat psychiatric disorders, including anxiety and depression.
“This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds,” said Dr. Edward Sellers, chair of Diamond’s scientific advisory board.
Diamond expressed plans to continue this research with a Phase 2 trial to investigate the efficacy of low-dose psilocybin in treating anxiety, which is the most common mental health disorder in the U.S. and causes moderate to severe disability in over 50% of sufferers.
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