Nova Advances Autism Research with Unique Psilocybin Microdosing Health Canada Approved Trial
May 26, 2023 2:14 pm
Nova Mentis has been setting the stage over the past several years for a potentially ground-breaking trial designed to provide new treatment options for the cognitive and behavioural symptoms associated with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).
From delivering promising preclinical research and collaborating with some of the brightest minds in the business, to producing >98% pure psilocybin capsules and earning approvals from all the necessary regulatory agencies, we are now set to begin testing our microdose psilocybin formulation on adult patients diagnosed with FXS.
Last month, we begun recruiting participants into the first-ever clinical trial investigating the safety and efficacy of psilocybin for FXS. Why do we think psilocybin can help with this condition? We believe that serotonergic insufficiency during childhood may have a compounding effect on brain patterning in ASD and FXS, manifesting as behavioural and emotional symptoms. Psilocybin is expected to mimic serotonergic signaling when innate serotonin synthesis is low, as is common in developmental delay.
The study is being led by our research partner, KGK Science, and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day. To qualify, you must be aged 18-50 with a FXS diagnosis. We are looking for participants with an IQ of 40-85 who can swallow capsules and are in general good health.
This is a 10-person, 28-day study with visits to the KGK Science clinic in London, Ontario, Canada at screening, baseline, day 7, 14, 21 and 28. Participants will be given a repetitive low-dose of psilocybin (1.5mg). All initial doses will occur at the KGK Science clinic under medical supervision to watch for any adverse effects.
A microdose is approximately one-tenth of a full dose. We believe that microdosing could provide similar benefits as full-dose interventions with less risk of adverse reactions and without the hallucinogenic effects experienced with higher doses.
The capsules being used in the study are pharmaceutical grade, cGMP >98% pure synthetic psilocybin, and were produced according to defined manufacturing processes and product specifications as outlined in chemistry, manufacturing and controls (CMC) published guidelines.
There will be paid compensation of up to $750 for each qualified participant upon completion of this study.
To express your interest in participating, please complete this eligibility questionnaire.
Please email, call 1-833-858-8359 or click here if you would like more information about this research.