Clinical TrialHealthy VolunteersPsilocybinCompleted

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.

Target Enrollment
8 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + midazolam

experimental

Single-arm open trial: single 25 mg oral psilocybin combined with repeated IV midazolam boluses administered in a supportive set-and-setting protocol.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total
  • Compound
    via IV• boluses titrated

    Repeated IV midazolam boluses titrated to sedation/amnesia; total dose individualized by age, weight, and response.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 21 to 65 years at screening
  • Medically healthy (does not meet criteria for an exclusionary medical condition)
  • No current DSM-5 psychiatric diagnosis
  • No current use of psychotropic medications
  • Ability/willingness to complete all study activities
  • Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)
  • Speaks and reads English
  • No use of psychedelic drugs within prior 3 months of dosing visit
  • Able to swallow oral medications
  • Refrain from use of psychotropic medications and illegal psychoactive substances from screening until study termination
  • Tobacco/nicotine abstinence from screening until study termination; alcohol abstinence 72 hours prior to dosing visit

Exclusion Criteria

  • Exclusion Criteria:
  • Pregnancy
  • Current exclusionary medical illness
  • Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behaviour within prior 12 months
  • Clinically significant safety lab abnormalities (CBC, CMP, urinalysis)
  • Clinically significant electrocardiogram (ECG)
  • Hypertension or tachycardia
  • First-degree relative(s) with a history of schizophrenia, schizophreniform disorder, bipolar I disorder, bipolar II disorder, or major depressive disorder with psychotic features

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment8 participants
  • Timeline
    Start: 2021-05-21
    End: 2023-12-01
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

UWHealth, 600 Highland Avenue — Madison, Wisconsin, United States

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