Cybin Inc. CYBN announced key highlights from its successful feasibility study conducted by its partner HI, LLC dba Kernel that tested its wearable technology to measure ketamine's psychedelic effect on the brain.
Results from this Cybin-sponsored study are intended to inform the future pathway for this program, explained CEO Doug Drysdale who called them “very promising.
"The possibility of using this technology to develop a predictive tool to aid in identifying appropriate candidates for psychedelic-based therapy is also quite exciting, as is the convenience of a portable device, which could lend itself to more widespread use in clinical settings.”
Cybin's sponsorship in the feasibility study allows it to retain an exclusive interest in any innovations discovered or developed through its independent analysis of the study findings.
Kernel's founder and CEO Bryan Johnson said the study constitutes “an important step towards larger-scale clinical studies using Kernel Flow to quantify the impact of psychedelics, or other neuroactive substances and central nervous system drugs, on the brain.”
Some of the highlights include providing proof-of-principle for Kernel Flow as a portable functional system providing real-time measurements of blood oxygenation changes in the brain associated with neural activity; demonstrated ketamine-induced changes to functional brain biomarkers associated with potential therapeutic effects including alterations in cortical function associated with psychedelic experiences.
One of the models combining neural and physiological metrics successfully predicted mystical experience scores on the Revised Mystical Experience Questionnaire, translating to potentially reduced depressive symptoms.
The Study Design
The study’s main goal was to assess a participant's experience wearing Kernel Flow while being in an altered state of consciousness, following the administration of ketamine. It received FDA IND approval in October 2021 and additional approval from the U.S. Institutional Review Board (IRB) approval in January 2022.
The 15 healthy volunteers had to complete study visits roughly once a week for four weeks: first a screening visit, then two dosing visits, and finally a follow-up phone call.
Dosing visits were placebo (saline, 0.9% NaCl) first and ketamine second, the ketamine visit occurring one week after the placebo one. Both were administered via intramuscular (IM) injections, with ketamine dosing based on participant weight (0.75 mg/kg, up to the maximum dose of 60 mg.)
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