Consciousness, Psilocybin, and Well-Being

NCT05592379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-16

No results posted yet for this study

Summary

This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.

Conditions

  • Healthy
  • Psychedelic Experiences
  • Sleep

Interventions

DRUG

Psilocybin

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

DRUG

Clonidine

Clonidine will be administered orally in a 0.2mg dose

OTHER

Saline

The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.

Sponsors & Collaborators

  • Usona Institute

    collaborator OTHER
  • Tiny Blue Dot Foundation

    collaborator OTHER
  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Charles Raison, MD · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2025-02-19
Completion
2025-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592379 on ClinicalTrials.gov