Pilot RECAP Study in Healthy Normal Volunteers
Pilot dosing, single-arm Phase 1 study (n=8 actual) evaluating single 25 mg psilocybin combined with repeated IV midazolam boluses to determine a midazolam regimen that permits a psychedelic experience while inducing amnesia for it in healthy volunteers.
Details
The PILOT RECAP study tests whether co‑administration of IV midazolam with a single 25 mg oral dose of psilocybin can produce a psychedelic experience followed by amnesia, to identify an optimal midazolam dosing schedule for later patient studies.
Psilocybin is given as a single 25 mg oral capsule; midazolam is delivered as repeated IV boluses titrated to the individual’s level of amnesia and sedation. The intervention is delivered within a standard set-and-setting (SaS) protocol including pre-dosing psychoeducation, support during dosing, and post-dosing integration.
Phase 1 enrolment includes medically and psychiatrically healthy adults; key exclusions include current psychiatric diagnosis, recent psychedelic use, pregnancy, significant labs/ECG abnormalities, cardiovascular instability, and relevant family history of psychosis.