Pilot RECAP Study in Healthy Normal Volunteers

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Midazolam; Psilocybin

Criteria

Inclusion Criteria:

• Age 21 to 60 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

• Able to swallow oral medications

Exclusion Criteria:

• Pregnancy

• Current exclusionary medical illness

• Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behavior within prior 12 months

• Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and 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, major depressive disorder with psychotic features