Potential Road To At-Home Psychedelics Use Permits: Low Dosing's Positive Outcomes In Phase 1 Trial

Canadian drug development company Diamond Therapeutics Inc. announced it has successfully completed its Phase 1 clinical study on low-dose psilocybin and shared the trial’s most relevant results. 

The Toronto-based company is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a spectrum of mental health disorders.

As such, the randomized, double-blind, placebo-controlled study assessed safety and efficacy of a single-ascending low dose of psilocybin in fifty-six subjects over four and a half months.

The company states that the trial is the first to identify a safe, active, well-tolerated, non-psychedelic -but yes psychoactive- dose range of psilocybin. "Before this study, little, if any, controlled research had been done to investigate low doses of psilocybin," commented Diamond’s CMO Dr. Michael B. McDonnell. 

Furthermore, the company’s lead medical officer noted that the study showed that low-dose psilocybin is “well-tolerated with no adverse events that would preclude its usage on an outpatient basis at home, removing the barrier of lengthy time spent in a clinic."

This point is particularly interesting, as it would open the door for future psilocybin-based medicines to be prescribed on an outpatient basis, against what experts in the field believe would take place regarding this specific psychedelic-assisted therapy.

As for upcoming steps, Diamond’s founder and CEO Judy Blumstock said results from this trial exceeded the company’s expectations, “bringing us closer to achieving our goal of providing new, better and more broadly accessible therapeutics to the millions of people struggling with mental health disorders," and that they will proceed “full tilt” with Phase 2 trial plans based on the data generated from the Phase 1 study.

The new study is being set to investigate the efficacy of low-dose psilocybin in the treatment of Generalized Anxiety Disorder (GAD) under Health Canada regulations.

Image by Mohamed Hassan from Pixabay