CompletedPhase 1psilocybin
Pilot RECAP Study in Healthy Volunteers
Sponsored by University of Wisconsin, Madison
NCT ID
NCT04842045
Target Enrollment
8 participants
Start Date
2021-05-21
Est. Completion
2022-11-17
About This Study
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.
Conditions Studied
Interventions
- •Psilocybin and Midazolam
Eligibility
Age:21 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility 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 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
Study Locations (1)
UWHealth, 600 Highland Avenue
Madison, Wisconsin, United States