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Safety Profile of Psilocybin for Cocaine Use Disorder

Not yet recruitingRegisteredCTG

This early-Phase I interventional trial (n=10) aims to assess the safety profile of psilocybin (25mg) in individuals with cocaine use disorder (CUD).

Details

The purpose of this single-group study is to establish the safe administration of 25 mg oral psilocybin in individuals with cocaine use disorder by assessing cardiovascular (heart rate, blood pressure) and subjective effects.

Ten participants attend a single 6-hour laboratory session (09:00–15:00) in a living-room-like environment with two clinicians present; psilocybin is given as five 5 mg capsules and measures are taken at 1-hour intervals.

No blood draws or neuroimaging are conducted; remote check-ins occur at 48 hours and at days 10, 50, and 90 post-session to monitor safety and wellbeing.

Topics:Substance Use Disorders (SUD)

Registry

Registry linkNCT06102434