Status:
COMPLETED
Pilot RECAP Study in Healthy Volunteers
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Psychedelic Experiences
Amnesia
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief 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 (P...
Detailed Description
The PILOT RECAP Study will investigate the effect of co- administering the amnestic agent midazolam with a single 25 mg dose of psilocybin on the induction of a psychedelic experience and subsequent m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04842045
Start Date
May 21 2021
End Date
November 17 2022
Last Update
May 19 2023
Active Locations (1)
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1
UWHealth, 600 Highland Avenue
Madison, Wisconsin, United States, 53792